John Block: “COOL” Isn’t Cool

By John R. Block

As a farmer, we understand that if you have something that doesn’t work, you fix it. It will just cost you money if you ignore the problem. Somehow, the federal government doesn’t seem to understand that common sense fact.

The Country of Origin Labeling (COOL) law was first passed in 2002. Canada and Mexico have been challenging the law now for 13 years. The World Trade Organization (WTO) just this week ruled it to be a violation of U.S. international trade obligations. We are a member of the WTO and therefore should live within the rules. That is our obligation, and we expect other countries to do the same.

This week, for the third time, the WTO ruled against us. That ruling gives Canada and Mexico the legal right to retaliate. Canada already has a list of proposed restrictions, which will result in a dramatic cut in our exports to Canada and Mexico. That is serious. Canada and Mexico are our number 1 and 2 export markets. Besides, they are our closest neighbors.

Senator Pat Roberts (KS) had this to say: “If Congress doesn’t act swiftly, retaliation will wreak havoc on the U.S. economy.” I think we should be aware that if we don’t fix this law, it will cost us millions of dollars in ag exports as well as other exports.

The law today requires that meat from a calf born in Canada and shipped to the U.S. bare a label that reads “Born in Canada, raised and slaughtered in U.S.”  Just imagine the cost and confusion that can cause.  What about the Montana farmer who imports Canadian calves and mixes his own U.S. calves with the Canadian calves?  By law, he would have to keep track of them and market them separately. The U.S. processing plant would then have to process them separately. That would be the only way to ensure the Canadian label was on the Canadian steak.

Consumers say they have the right to know where that animal has been. Why? It isn’t worth the hassle. USDA just released new study results that point out the COOL labeling policy costs consumers nearly 8 billion dollars over 10 years.

We don’t need to try and change COOL. We’ve tried that before. COOL isn’t cool. Just get rid of it.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

Recapping Round 1 of the Vermont GMO-Labeling Lawsuit

By John G. Dillard

Millions across the globe tuned into this weekend’s Mayweather-Pacquiao bout, which was billed as “the fight of the century.” However, the pay-per-view event was not the only high stakes fight to report on from last week. Far away from the glitz and glamor of Las Vegas, a federal court in Vermont issued a much-anticipated opinion in what will be one of the true fights of the century for the American food industry – whether state governments can mandate GMO labels.

On April 27, 2015, Chief Judge Christina Reiss of the U.S. District Court for the District of Vermont issued an opinion that mostly favored the State of Vermont and the positions of GMO-labeling advocates. In the case, Grocery Manufacturers Association v. Sorrell (No. 5:14-cv-117), the Grocery Manufacturers Association, Snack Food Association, International Dairy Foods Association, and National Association of Manufacturers (the “Plaintiffs”) are challenging Vermont’s Act 120, which requires that certain foods sold at retail stores in Vermont bear mandatory labeling if they contain genetically-engineered ingredients. Act 120 also prohibits manufacturers from advertising or labeling foods that contain genetically-engineered ingredients as “natural” or “all natural.”

Both supporters and opponents of mandatory GMO-labeling have been keeping a close eye on this lawsuit. This is because Act 120, if it survives litigation, will make Vermont the first state in the country to require that certain foods containing ingredients produced with genetic engineering bear mandatory labels. GMA v. Sorrell is the test case for this issue, which will certainly reach the Second Circuit Court of Appeals and, possibly, the Supreme Court.

The Plaintiffs challenged Act 120 from several angles. First, the Plaintiffs asserted that Act 120’s GMO-labeling mandate was unconstitutional under both the First Amendment and the Constitution’s Commerce Clause. The Plaintiffs also argued that the GMO-labeling mandate was preempted by the Federal Food, Drug, and Cosmetic Act (FFDCA), the Nutritional Labeling and Education Act (NLEA), the Federal Meat Inspection Act (FMIA), and the Poultry Products Inspection Act (PPIA). Furthermore, the Plaintiffs asserted that the ban on “natural” labeling is unconstitutional under the Commerce Clause and the First Amendment.

The State of Vermont filed a motion to dismiss the Plaintiffs’ case on August 8, 2014. Subsequently, the Plaintiffs sought a preliminary injunction that would halt implementation of Act 120 while the Court decides whether to issue a permanent injunction invalidating Act 120. Chief Judge Reiss heard oral arguments on both of these motions on January 7, 2015, and issued an 84-page opinion in the case last Monday.

GMO-Labeling Mandate

The Plaintiffs challenged Act 120’s GMO-labeling mandate under the First Amendment, Commerce Clause, and Supremacy Clause. Here is how the Court addressed these issues:

  • First Amendment. The Plaintiffs alleged that Act 120’s GMO-labeling mandate violated the First Amendment’s protections against unlawfully-compelled speech. The Court held that “strict scrutiny” was not warranted in this case and dismissed the Plaintiffs’ complaint to the extent that it argued strict scrutiny applied. Instead, the Court held that the proper standard is most likely the “reasonable relationship” test. Under this test, also known as the Zauderer test, the Court held that for the purposes of preliminary injunction, the Plaintiffs were not likely to succeed on their First Amendment complaints. The Court reasoned that unless Vermont’s “legislative findings” prove unfounded at the permanent injunction stage of this litigation, the State has demonstrated a reasonable relationship between the state’s interest and the GMO-labeling mandate.
  • Commerce Clause. The Plaintiffs argued that Vermont’s labeling measure violates the Constitution’s Commerce Clause because the state-based labeling measure would create an undue burden on interstate commerce, ultimately resulting in a 50-state patchwork of labeling laws. The Court was not convinced, noting that there were no other states with conflicting labeling laws. The Court dismissed the Plaintiffs’ complaint to the extent that it alleged the GMO-labeling mandate was unconstitutional under the Commerce Clause.
  • Supremacy Clause. The Plaintiffs asserted that the GMO-labeling mandate was preempted by the FFDCA, NLEA, FMIA, and PPIA. The Court was not convinced by the Plaintiffs’ arguments with regards to the FFDCA or the NLEA. However, the Court agreed that the FMIA and PPIA expressly preempted state standards for “[m]arking, labeling, packaging, or ingredient requirements in addition to, or different than, those mandated by federal law.” This means that processed and packaged foods that are subject to USDA inspection, such as canned soups or frozen dinners containing meat or poultry products, cannot be subject to state GMO-labeling mandates. Vermont has already conceded this issue in its final rule, which implements Act 120.

“Natural” Labeling Prohibition

The Plaintiffs also challenged Act 120’s prohibition on advertising and labeling of products containing genetically-engineered ingredients as “natural,” “all natural,” or words of similar import. The Plaintiffs argued that this prohibition violated the First Amendment. The Court sided with the Plaintiffs on the First Amendment argument, reasoning that prohibitions on commercial speech are subject to “intermediate scrutiny” under the Central Hudson test. The Court held that Vermont has failed to demonstrate a “substantial” state interest in prohibiting these labels. The Court also held that the “natural” labeling prohibition violated the Commerce Clause to the extent that it attempted to regulate advertising that occurred outside of Vermont.

Although the Court largely sided with the Plaintiffs on the “natural” labeling prohibition, Chief Judge Reiss did not grant a preliminary injunction on this matter, citing to a lack of proof of “irreparable harm” on the part of the Plaintiffs.

Next Steps

This first round of the litigation is certainly a setback for those in the food industry that oppose state-level GMO-labeling mandates. However, this is only the first round. The Plaintiffs have not announced their next steps. At this point, they may either (1) seek an interlocutory appeal of this decision at the Second Circuit Court of Appeals, or (2) move forward to the permanent injunction stage of this litigation.

In the meantime, support is growing for the proposed Safe and Accurate Food Labeling Act of 2015, which would preempt state GMO-labeling measures and set standards for when GMO labels could and could not be required. However, no votes have been taken on this measure and it is uncertain whether the measure has a chance of being enacted into law.

OFW Law will continue to monitor developments in this case.

The Vilsapp: Secretary Vilsack’s High Tech Solution to Labeling

By Marshall L. Matz, as published in Agri-Pulse

The March edition of the National Geographic Magazine, in its cover story entitled “The War on Science,” notes that “there’s no evidence that GMO’s are harmful to human health.” A recent Pew poll found that 90% of all scientists believe GMO’s are safe but only 37% of the public agrees. In short, the public is skeptical and is seeking more information about foods made with genetic engineering. We live in an era of transparency, open data and the world-wide web. It is difficult to deny consumers the right to know what is in their food. And given the safety of genetic engineering, there is no reason to block that information.

The question on the table is how to do this in a nationally-uniform, unbiased manner? To allow each of fifty states to have its own labeling scheme would be confusing, very expensive, bad public policy and, in my opinion, unconstitutional. It would be as crazy as having fifty different Dietary Guidelines or fifty different Nutrition Facts panels on the foods we buy.

Secretary VilsackAgriculture Secretary Tom Vilsack has a better idea: a smartphone application that can scan a bar code on the food package and tell the consumer what is in the product. He took his idea to Congress last month. His idea is a very modern and clever solution to address the desire for more information about the foods we consume.

There is only so much room on the food label. So, Secretary Vilsack is suggesting a symbol on the food label that connects to a database that can tell those consumers who want such information whether there is an ingredient in the food produced with genetic engineering. According to a recent edition of the Economist, “about half of the adult population owns a smartphone; by 2020, 80% will. Smartphones have also penetrated every aspect of daily life.” For those without smartphones, there could be in-store computers or scanners.

Dr. Cathy Enright, VP for Agriculture at the Biotechnology Industry Organization (BIO), posted a blog last month that said:

“I also support a right-to-know. In 21st century America, consumers are increasingly asking questions about how their food is grown and made. We all need to be working together to provide that information, in a way that doesn’t misinform consumers. Have you seen USDA Secretary Vilsack’s idea….using a bar code or other code on a food package or sticker?”

Last year, Cardinal Peter Turkson, speaking on behalf of the Vatican, said we must use biotechnology to feed the world’s expanding population, but also supported the idea of transparency to provide information to consumers who desire such information. The Vatican seems to be in agreement with the Secretary and those who believe in both the safety of genetic engineering and the moral imperative of using science to feed the hungry, but also the consumers’ right to know.

Nutrition FactsUSDA and HHS will issue a new edition of the Dietary Guidelines for Americans later this year. The Dietary Guidelines Advisory Committee and the FDA are seeking to put more information on the actual food label. It is time to use technology to expand the physical size of the label.

Every industry seems to be using technology to the maximum possible extent. The food industry should follow suit. There are questions that would still have to be resolved as with any app: who would maintain the data base? What would be the definition of genetic modification and would there be some threshold that triggers the GE designation? What happens with foods that used a GE ingredient where it was then processed out of the product and there is no trace in the final food?

These are all challenging questions that would have to be resolved. But this much is clear, there must be federal preemption of state labeling schemes and a uniform national system established. To date, the labeling campaign has been pushed as an attack on genetic engineering as a part of the larger war on science. Information should be provided, not as a scare tactic and warning, but just as factual information for those who care.

Perhaps there is a better idea than the Vilsack App, but this idea sure deserves serious attention. On March 5th, at the House Agriculture Appropriations Subcommittee hearing to review the FDA budget, Dr. Hamburg reiterated that FDA does not see mandatory labeling as appropriate if there’s not a significant change to the product. If the process changes the nature of the product, then it would have to be labeled. She also said FDA supports individual companies that want to voluntarily label products and plans to issue a guidance to guide them in the near future. Dr. Hamburg should include the Vilsapp as a way of providing consumer information and include it in the guidance that FDA issues.

The Wall Street Journal recently published a guide to some of the terms being used on supermarket egg cartons. They include Organic, Cage-Free, Free-Range, All Natural, Pasture Raised, and Vegetarian Fed and Omega-3. The Vilsapp could help the confused consumer better understand these terms as well.

In short, the Vilsapp is a creative idea that could provide the transparency deemed important by consumers and also preempt the need for state legislation. The need for state preemption is paramount and was emphasized by all of the witnesses at the House Agriculture Hearing on March 24th.

Dr. Nina Fedoroff, the Senior Science Advisor at OFW Law, concluded her testimony with the following: “We will need to produce more crops per drop of water and square meter of land” in order to feed 9 to 10 billion of people. Genetic modification is not a magic bullet but is safe and an important part of the arsenal needed to defeat food insecurity.

A patch quilt of different state labeling schemes would be a barrier to global food security. Transparency and full disclosure is reasonable but it must be done with a national system that is based on sound science and provides objective information.

Mr. Collin Peterson, the Ranking Member, summed it up best: “When it comes to labeling, we need to be able to find a smart way to balance the consumer demand with what we know about the safety of the foods that our farmers produce.” Sounds like a Vilsapp.

Marshall Matz, formerly Counsel to the Senate Select Committee on Nutrition and the Senate Committee on Agriculture, specializes in agriculture and nutrition at OFW Law.

CDRH’s 2015 Weather Forecast Predicts A Storm of Guidance Documents

By Mason Weeda

Earlier this month, FDA’s Center for Devices and Radiological Health issued its FY 2015 Proposed Guidance Development and Focused Retrospective Review of Final Guidance.  CDRH lists 28 guidance documents in total.  The “A-list” includes both draft and final guidances that CDRH intends to publish by January 2016, and the “B-list” includes guidance documents that it intends to publish “as resources permit.”   CDRH is required by the Medical Device User Fee Amendments of 2012 to publish these lists.

The “A-list” includes the following final and draft guidances:

  1. Applying Human Factors & Usability Engineering to Optimize Medical Device Design (Final);
  2. 510(k) Submissions for Medical Devices that Include Antimicrobial Agents  (Final);
  3. Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval (Final);
  4. Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (Final);
  5. Framework for Regulatory Oversight of Laboratory Developed Tests (Final);
  6. FDA Notification and Medical Device Reporting for Laboratory Developed Tests (Final);
  7. Coronary Drug Eluting Stents-Nonclinical and Clinical Studies (Final);
  8. Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements (Final);
  9. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (Final);
  10. Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications (Final);
  11. Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile (Final);
  12. Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing Biocompatibility (Final);
  13. General Wellness Products (now published in Draft);
  14. Medical Device Accessories (now published in Draft);
  15. Medical Device Decision Support Software (Draft);
  16. Benefit-Risk Factors to Consider When Reviewing IDE Submissions (Draft);
  17. UDI Direct Marking (Draft);
  18. Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements (Draft);
  19. Adaptive Design for Medical Device Clinical Studies (Draft); and
  20. UDI FAQs (Draft).

The “B-list” includes the following:

  1. Finalizing various existing draft guidance documents;
  2. Medical Device Interoperability (Draft);
  3. Transfer of Ownership of a Premarket Notification: Questions & Answers (Draft);
  4. Direct Access Genetic In Vitro Diagnostics Testing (also known as Direct to Consumer Genetic Testing) (Draft);
  5. Patient Access to Information (Draft);
  6. 3D Printing (Technical) (Draft);
  7. Manufacturing Site Change Supplements (Draft); and
  8. Use of Symbols in Labeling (Draft).

Significantly, CDRH acknowledges that it is not realistic for FDA to publish all guidances on both the “A-list” and the “B-list” by January 2016 and that priorities may change throughout the year.

The Agency also published a third list, containing final guidance documents that were issued in 2005, 1995, and 1985 and are now subject to retrospective review.  CDRH will conduct “a staged review of previously issued final guidances in collaboration with stakeholders,” and it is seeking feedback on whether such guidance documents should be revised.  These guidance documents are:

1985 Final Guidances include:

  1. Medical Laser Delivery System Interlocks (Laser Notice 34) (PDF – 90KB) (1/20/1985);
  2. User Instruction Hazard Warnings (Laser Notice 35) (PDF – 63KB) (2/5/1985);
  3. Policy on Warning Label Required on Sunlamp Products (PDF – 71KB) (6/25/1985);
  4. Low Power Laser Exemption (Laser Notice 36) (PDF – 101KB) (8/23/1985); and
  5. Walk-In Workstations (Laser Notice 37) (PDF – 86KB) (10/21/1985).

1995 Final Guidances include:

  1. Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters (PDF – 896KB) (3/15/1995);
  2. Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians’ Office Laboratory and Home Use (7-13-1995);
  3. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Submerged (Underwater) Exercise Equipment (7/26/1995);
  4. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Electromyograph Needle Electrodes (7/26/1995);
  5. Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles (7/26/1995);
  6. Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Immersion Hydrobaths (7/26/1995);
  7. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Tables and Multifunctional Physical Therapy Tables(7/26/1995);
  8. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems (7/26/1995);
  9. Guidance Document for the Preparation of Notification (510(k)) Applications for Therapeutic Massagers and Vibrators (7/26/1995);
  10. Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Heating and Cooling Devices (7/26/1995);
  11. User Instruction for Medical Products (Laser Notice 44) (PDF – 123KB) (8/11/1995);
  12. Labeling of Laser Products (Laser Notice 45) (PDF – 90KB) (8/15/1995); and
  13. Guidance On The Content Of Premarket Notification [510(k)] Submissions For Protective Restraints (Text Only) (12/1/1995).

2005 Final Guidances include:

  1. Guidance for Industry – Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (1/14/2005);
  2. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/2005);
  3. Guidance for Industry and FDA Staff – Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) (7/27/2005);
  4. Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features (8/9/2005);
  5. Guidance for Industry – Review Criteria for Assessment of C Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays (9/22/2005);
  6. Guidance for Industry and FDA Staff: Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions (10/26/2005);
  7. Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 C.F.R. § 1040.30) (11/6/2005);
  8. Guidance for Industry and FDA Staff: A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures (11/10/2005); and
  9. Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s (11/17/2005).

FDA has established a docket for comments on any or all of the proposed FY2015 guidance documents or guidance documents subject to CDRH’s focused retrospective review.  FDA invites stakeholders to submit comments on the guidance documents listed, the relative priority of guidance documents for Agency attention and/or suggestions that CDRH revise or withdraw a final guidance document that issued previously in 2005, 1995 or 1985.

A Flurry of End-of-Year Activity from FDA on Food

By Robert A. Hahn

In what seemed like a bit of end-of-year housekeeping, FDA issued a series of minor guidance documents, notices, and other regulatory paraphernalia related to food.  Coming in under the wire in 2014 were:

  • A notice requesting nominations for non-voting industry representatives to the Food Advisory Committee. Nominations are due by January 7, 2015.  FDA is also requesting that industry organizations interested in participating in the selection of non-voting industry representatives to the Food Advisory Committee should notify FDA in writing of their interest by January 7, 2015.
  • A notice requesting nominations for voting members to FDA’s Food Advisory Committee. Nominations are due by January 30, 2015.
  • A final rule establishing January 1, 2018 as the uniform compliance date for food labeling regulations issued between January 1, 2015 and December 31, 2016.
  • A response to objections to FDA’s final rule approving advantame as a non-nutritive sweetener and flavor enhancer for use in foods generally, except for meat and poultry products. FDA determined that the final rule approving advantame should not be modified and confirmed the final rule’s May 21, 2014 effective date.
  • A final guidance document on labeling of certain beers subject to FDA labeling jurisdiction – Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration. Under the guidance, beers that are not made from both malted barley and hops but instead made from substitutes for malted barley, such as sorghum, rice, or wheat, or are made without hops (other than sake, which is classified as a wine), are not “malt beverages” under the Federal Alcohol Administration Act.  Such beers must comply with FDA labeling requirements, but are also subject to certain Alcohol and Tobacco Tax and Trade Bureau (TTB) labeling requirements (g., the Government Health Warning Statement about consumption of alcoholic beverages).
  • A final guidance document on labeling of processed and blended seafood products made primarily with fish protein – Compliance Policy Guide Sec. 540.700 (Labeling of Processed and Blended Seafood Products Made Primarily with Fish Protein).
  • A notice announcing the availability of a revised draft guidance document on the level of coli in crabmeat at which the agency will consider crabmeat products to be adulterated (i.e., 3.6 Most Probable Number per gram (MPN/g) of E. coli) – Compliance Policy Guide Sec. 540.275 (Crabmeat – Fresh and Frozen – Adulteration with Filth, Involving the Presence of the Organism Escherichia coli). To be considered before FDA begins work on a final guidance, comments must be received by February 17, 2015.
  • An update on other pending food labeling matters – Update for Industry on Certain Proposed Rules, Draft Guidance and Petitions Related to Food Product Labeling.  This update includes some interesting tidbits about the current status of matters FDA did not complete in 2014.  For example, FDA completed data collection for a consumer study on “whole grain” label statements, and is now considering comments received on FDA’s 2006 draft guidance and developing a final guidance document on this subject.  Missing is any mention of the status of a final guidance document on “non-GMO” label statements, which FDA had promised to issue in 2014.

Some notable end-of-year announcements related to food made by other federal agencies include:

  • An announcement of a public workshop on “Options for Consideration of Chronic Disease Endpoints for Dietary Reference Intakes” to be held on March 10 and 11, 2015 by the Dietary Reference Intakes (DRI) Committees of the U.S. and Canada. The workshop will evaluate the scientific issues involved in using chronic disease endpoints to set DRIs.  The DRI Committees are also requesting public comments on the specific questions posed in the workshop announcement.  Comments are due January 30, 2015.
  • Recommendations of the Presidential Task Force on Combating Illegal, Unreported and Unregulated Fishing and Seafood Fraud.  The recommendations submitted to President Obama by the Task Force include: work with Congress to pass legislation implementing the 2009 Agreement on Port State Measures to Prevent, Deter, and Eliminate Illegal, Unreported and Unregulated (IUU) Fishing; direct the Secretaries of Agriculture, Commerce, Health and Human Services (HHS), Homeland Security, and Interior and the Attorney General to develop a strategy to collect, share, and analyze information and resources to prevent IUU and fraudulently labeled seafood from entering U.S. commerce; direct the Secretaries of Agriculture, Commerce, HHS, and Homeland Security to standardize and clarify rules on identifying the species, common name, and origin of seafood; direct the Task Force to establish a regular forum with harvesters, importers, dealers, retailers, processors, and non-governmental organizations to improve collaboration in combating IUU fishing and seafood fraud; direct the Task Force to develop a list of the types of information and operational standards needed for an effective seafood traceability program; and direct the Task Force to establish the first phase of risk-based traceability program to track seafood from point of harvest to entry into U.S. commerce.  Comments on the recommendations are due by January 20, 2015.

2014 And 2015

By Arthur Y. Tsien

As we say goodbye to 2014 and welcome 2015, it’s time for a little backward and forward looking.

Here’s what we saw in the 2014 rear view mirror in our little corner of the Universe devoted to the regulatory aspects of foods, drugs, medical devices, agriculture, and the like.

In January, the Food and Drug Administration (FDA) published its long-awaited, long-overdue draft guidance on the promotion of drug and biologic products in interactive social media.  The draft guidance, formally entitled “Fulfilling Regulatory Requirements for Post-Marketing Submission of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics,” is long on process (how and when to make required submissions to FDA), and short on substance.  Presumably, draft guidances that will address FDA’s views on the substantive content of drug and biologic promotion through social media will follow.

The Agricultural Act of 2014, almost universally known as the 2014 Farm Bill, became law in February.  The Farm Bill is the primary agriculture and food policy tool of the federal government. Enacted every five years, plus or minus (mostly plus), the Farm Bill addresses a broad range of substantive programs administered by the U.S. Department of Agriculture (USDA), including commodity programs, rural development, foreign agriculture and trade, conservation, renewable energy, forestry, nutrition, and other topics.  Unbeknownst to the average American, the Supplemental Nutrition Assistance Program (commonly known as “food stamps”) and other nutrition assistance programs represent by far the biggest expenditure of funds under the Farm Bill.

In March, FDA proposed to update its “Nutrition Facts” nutrition labeling requirements, which have largely been unchanged for over 20 years.  The proposed changes appear to be significant for industry, as FDA estimates the compliance price to be $2 billion.  Even if the proposed changes are not readily noticeable to more casual observers (like me), they are surely of major interest to my colleagues who spend their time looking at the back or side panels of pasta sauce jars or cereal boxes.

In April, President Obama appeared to signal his support for the important role that biotechnology plays in modern agriculture.  Mr. Obama did so in a letter to the granddaughter of Dr. Norman Borlaug, the Nobel laureate who is often recognized as the “Father of the Green Revolution.”

In May, Vermont became the first state to require labeling of genetically engineered foods.  Effective in 2016, Vermont will require the affirmative labeling of foods containing ingredients that are commonly referred to as “genetically modified organisms” or “GMOs.”  The legislation may be vulnerable to a constitutional challenge under the First Amendment.  It, and the prospect of similar legislation in other states, may also serve as the impetus for federal legislation that would preempt some or all state labeling laws related to GMOs.

In June, the U.S. Supreme Court decided Pom Wonderful LLC v. Coca-Cola Co.  The Court held that a company may bring a private lawsuit against a competitor under the Lanham Act to challenge the competitor’s food label, even if the competitor’s label technically complies with FDA requirements.  In essence, the Pom Wonderful decision means that FDA food labeling requirements are a floor, but not a ceiling.  It appears that Pom Wonderful is limited to FDA-regulated products where FDA does not approve or mandate specific labeling, such as food and beverage products.

The Biologics Price Competition and Innovation Act became federal law in 2009, creating a regulatory pathway for FDA approval of “biosimilar” products.  In July, FDA finally accepted the first biosimilar application under that statute.

In August, Grocers Manufacturers Association (GMA) announced an industry initiative that is, in its view, designed to improve the process and transparency for making “generally recognized as safe” (GRAS) determinations for food ingredients.  GMA’s GRAS initiative is intended to respond to criticism about the widespread use of the GRAS process, including FDA’s GRAS notification pilot program, as a mechanism for the review and marketing of new or modified food ingredients.

September marked the 30th anniversary of the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.  Hatch-Waxman is the legislative foundation for the modern generic drug industry in the United States.  Today, generic drugs account for about 80 percent of all prescriptions filled in the U.S.  My personal musings on 30 years of Hatch-Waxman can be found here.

In October, the World Trade Organization ruled in favor of Canada and Mexico, rejecting USDA’s mandatory country-of-origin labeling (COOL) requirements for meat products.  The current U.S. labeling rules, which went into effect in 2013, require meat sold at the retail level to identify the country or countries where the animal was born, raised, and slaughtered.  The USDA COOL requirements were upheld by the D.C. Circuit earlier in 2014.  The U.S. has appealed within WTO; a decision early in 2015 is expected.

In November, OFW Law celebrated its semiseptuagennial anniversary.  Phil Olsson and Rick Frank founded Olsson and Frank in 1979 as a two-lawyer shop.  Fast-forward 3½ decades to 2014.  OFW Law now has nearly 40 lawyers and Policy Advisors, and is one of the few remaining FDA/USDA law and lobbying boutique firms.  Phil’s and Rick’s musings on the past 35 years can be found here.  We look forward to our second 35 years of providing outstanding client service, with creative solutions to difficult problems.

In December, FDA published two companion final rules regarding the labeling of foods sold in chain restaurants and in vending machines.  Covered chain restaurants (and similar chain retail food establishments) will have to declare the caloric content of standard menu items on menus and menu boards and make other nutrition information available on the premises.  Restaurants that are not covered by the final rule may voluntarily register with FDA to receive the protection of federal preemption from inconsistent state and local menu labeling laws.  Foods sold in vending machines will also have to declare caloric content.  Most packaged foods sold in vending machines likely will provide caloric information in the form of a “front-of-pack” label that can be viewed by prospective purchasers.

*          *          *

Enough looking back.  Let’s briefly turn our attention to looking forward, to see what 2015 may have in store for us.  The following come to mind:

  • FDA final rules under the Food Safety Modernization Act (FSMA) on produce safety, preventive controls for human food, preventive controls for animal food, and foreign supplier verification, presumably by the court ordered deadlines in 2015. (Other FSMA final rules have 2016 deadlines.)
  • FDA’s first biosimilar approval. There is no track record here, so no one knows quite what to expect.  For whatever it’s worth, FDA review of biosimilar applications is subject to user fee performance goals, much like user fee performance goals for a variety of other products that require FDA premarket approval.
  • Additional FDA guidance on drug and biologic promotion through social media, hopefully addressing the substance of what FDA considers acceptable and not acceptable.
  • Federal GMO labeling legislation to preempt some or all state requirements in this area.
  • The WTO’s final decision on USDA’s COOL requirements.
  • The extent of cooperation between President Obama and the Republican Congress. Personally, I’m skeptical that they can work together towards less gridlock and more bipartisanship going forward.

*          *          *

Thanks for reading!  Best wishes to one and all for a wonderful 2015, personally and professionally.  May 2015 be better than 2014!

GMO Hearing

By Peter B. Matz

Yesterday, the House Energy and Commerce Subcommittee on Health held a hearing to examine FDA’s role in the regulation of genetically engineered foods (commonly, but inaccurately, referred to as “genetically modified organisms” or “GMOs”).  Congressman Mike Pompeo’s (R-KS) Safe and Affordable Food Act (H.R. 4432), which would preempt state GMO labeling laws and require labeling only if a food product were deemed unsafe or materially different by the FDA, was also a major focus of the hearing.  While the bill will die at the end of this Congress, it is expected to be reintroduced in the 114th Congress.  Following are a few key takeaways:

  • There was general consensus among Committee Members from both parties that a federal GMO labeling standard applied nationwide would be more sensible than state-by-state regulations.
  • When Rep. Pompeo asked the second panel, which included two GMO labeling advocates, to answer with a yes or no whether they agreed GE foods are as safe as their conventional counterparts, all four witnesses answered, “yes.”
  • Several Members, on a bipartisan basis, expressed concern that a mandatory label disclosing the inclusion of GE ingredients which present no health or safety risk could be inherently misleading.  For example, Full Committee Ranking Member Henry Waxman (CA) argued that a label could unintentionally appear to imply that the foods are somehow less safe than conventional varieties.
  • Michael Landa, FDA’s Director of the Center for Food Safety and Applied Nutrition, discussed the consultation process in which FDA reviews GMO foods before they go to market.  While it is technically voluntary, he explained that biotechnology companies comply with it because they know farmers will not buy GM seeds unless FDA has given the manufacturer a “no questions letter,” because they would never want to risk growing a product that FDA could later deem unsafe.
  • While the two GMO labeling proponents argued that consumers have a right to know what is in their food to be able to make informed decisions, University of California-Davis’ Dr. Alison Van Eenennaam asserted this issue is not about consumers’ right to know what is in their food, but rather how the food was produced.  “There is no science-based reason to single out foods derived from and feed crops that were developed using the GE breeding method for mandatory process-based labeling,” she stated.  Her written testimony is a powerful endorsement of agricultural biotechnology rebutting the concept of and need for mandatory GMO labeling.
  • In his opening statement, Chairman Joe Pitts (PA) quoted President Obama, who said “advances in the genetic engineering of plants have provided enormous benefits to American farmers” and that “investment in enhanced biotechnology is an essential component of the solution to some of our planet’s most pressing agricultural problems.”

The witness list, written testimony and archived webcast of the hearing can be found here.

FDA Shares the Pain in Final Rules on Menu Labeling and Vending Machine Food Labeling 1

By Robert A. Hahn

Citing the obesity epidemic and the fact that Americans consume about one-third of total calories in the form of foods prepared outside the home, FDA yesterday issued two sweeping  final rules on nutrition labeling of foods sold in chain restaurants and similar retail food establishments and vending machines.

There had been considerable controversy over how FDA would define “similar retail food establishments” covered by the menu labeling rule.  Would FDA exempt food concessions in movie theatres and other entertainment venues (as it did in its 2011 proposed rule), supermarkets, and convenience stores?  In the end, FDA chose to narrow somewhat the types of foods that will be subject to menu labeling rather than exempt broad categories of retail food establishments.

The final rules are highly prescriptive and contain few of the accommodations that had been requested by industry.  The rules implement Section 4205 of the Patient Protection and Affordable Care Act of 2010.

Menu Labeling

Who Is Covered?

The menu labeling rule applies to “covered establishments.”  A “covered establishment” is defined as a “restaurant or similar retail food establishment” that:

  • Is part of a chain with 20 or more locations;
  • Doing business under the same name (regardless of type of ownership); and
  • Offering for sale substantially the same menu items.

The definition also includes restaurants and similar retail food establishments that would not otherwise be covered (e.g., because they are not part of a chain with 20 or more locations) but that voluntarily register with FDA and agree to comply with the regulation.  Some restaurants that are not covered establishments may do this in order to receive the protection of federal preemption from state and local menu labeling laws.

A “restaurant or similar retail food establishment” means any retail establishment that offers “restaurant-type food,” except for schools.

A “restaurant-type food” is a food that is: (a) usually eaten on the premises, while walking away, or soon after arriving at another location (such as a home, a workplace, or a park); and (b) is either (i) a food of the type served in restaurants or other establishments for immediate human consumption, or (ii) is a food processed or prepared primarily in a retail establishment, ready to eat, offered for sale but not for immediate consumption, and not offered for sale outside such establishment.

Covered: quick service restaurants, table service restaurants, take-out and delivery establishments (e.g., pizza take-out establishments), bakeries, cafeterias, coffee shops, grocery stores, convenience stores, big box stores, delis, food concessions in entertainment venues, food service vendors (e.g., ice cream shops, mall cookie counters), and retail confectionery stores.  Not covered: schools, food trucks, ice cream trucks, and transportation carriers (e.g., airlines).

Which Foods Are Covered?

The regulation applies to “standard menu items.”  A “standard menu item” is defined as a “restaurant-type food” that is routinely included on a menu or menu board or routinely offered for sale as a self-service food or food on display.

As noted above, a “restaurant-type food” is a food that is usually eaten on the premises, while walking away, or soon after arriving at another location.  Covered (by way of example): foods served for immediate consumption in a restaurant; food purchased at a drive-through window; take-out and delivery pizza; pizza or nachos sold from a movie theatre concession; foods sold from a hot buffet, a soup bar, or a salad bar; food ordered from a menu or menu board in a grocery store; and self-service foods and foods on display intended for individual consumption (e.g., sandwiches at a deli counter, cookies from a cookie counter, bagels and donuts for individual sale).  Not covered: foods that consumers usually store for use at a later time or that are typically eaten over several eating occasions, and foods that are customarily further prepared (e.g., loaves of bread, whole cakes, bags or boxes of candy); foods sold from bulk bins (e.g., granola, nuts); foods not intended solely for individual consumption (e.g., deli salads such as potato salad, chicken salad, cole slaw); and foods usually further prepared before consuming (e.g., deli meats, cheeses).

A “standard menu item” also must be routinely offered on a menu or menu board or as a self-service food or food on display.  Not covered: items such as condiments offered for general use; custom orders; daily specials; temporary menu items (foods appearing on a menu or menu board for less than 60 days per calendar year); customary market test foods (food appearing on a menu or menu board for less than 90 consecutive days in order to test consumer acceptance); self-service foods and foods on display for less than 60 days per calendar year or less than 90 consecutive days); and alcoholic beverages that are foods on display and not self-service foods (e.g., a bottle of wine kept behind a bar).

What Information Is Required?

The menu or menu board must provide three items:

  • The number of calories per menu item (or per serving for multiple-serving items usually offered for sale divided in discrete serving units, provided the serving unit and number of servings are declared);
  • The following succinct statement about total caloric intake: “2,000 calories a day is used for general nutrition advice, but calorie needs vary”; and
  • The following statement about the availability of additional nutrition information: “Additional nutrition information available upon request.”

For self-service foods and foods on display, calories must be displayed on a sign adjacent to and clearly associated with the food, a sign attached to a sneeze guard, or a single sign or placard listing the calories for several such foods.

In addition, for each standard menu item, additional nutrition information must be available on the premises of the covered establishment upon request.  The additional information must include the following nutrients: total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, and protein.  This information may be provided in or on a counter card, sign, poster, handout, brochure, loose leaf binder, electronic device, menu, or any other form that is readily available on the premises and permits the customer to review it upon request.

What is a Menu or Menu Board?

FDA has opted for a broad definition of “menu or menu board” to mean “the primary writing… from which a customer makes an order selection.”   The word “primary” does not mean that a covered establishment has only one menu or menu board.  According to FDA, a writing will be considered a menu or menu board if it lists at least one standard menu item (or an image depicting a standard menu item) and the price of the standard menu item, and it can be used by a consumer to make an order selection at the time the consumer is viewing the writing.  Covered: a traditional menu or menu board, a paper take-out menu, a delivery menu, an online menu, a translite behind the counter that lists a standard menu item and its price, and a drive-through window menu board.  Not covered: a poster on a storefront, a coupon or other promotional material, a tray liner, a billboard, and stanchions.

When Must Covered Establishments Comply?

Covered establishments must comply by December 1, 2015.

Is There Federal Preemption?

Yes, the final rule will preempt all state and local laws that impose menu labeling requirements not identical to the federal law.

Vending Machine Labeling

Who Is Covered?

The final rule applies to “covered vending machine food,” which is defined as a food sold from a vending machine that is operated by a person owning or operating 20 or more vending machines or who has voluntarily registered with FDA and agreed to comply with the regulation. A “vending machine” is broadly defined to include any self-service machine that dispenses food without the need to replenish the machine between each vending operation.

Foods sold from vending machines are exempt if a prospective purchaser can view:

  • Calories, serving size, and serving per container information in the food’s Nutrition Facts label on the food without any obstruction;
  • Calories, serving size, and servings per container information listed in a reproduction of the food’s Nutrition Facts label on the food; or
  • Calories (total calories in the item, not calories per serving) on the food label (g., in a front-of-pack (FOP) label).

It is expected that most packaged foods sold in vending machines will provide calorie information in the form of an FOP label and will seek to qualify for the third exemption above.  For an FOP calorie label to qualify, however, it must:

  • Declare total calories for the entire item;
  • Appear in a type size that is at least 50% of the type size of the largest printed matter on the label; and
  • Appear with sufficient color and contrasting background as compared to other print on the label so as to permit a prospective purchaser to clearly distinguish it.

What Information Is Required?

A “covered vending machine food” must declare the total number of calories in the food clearly, conspicuously, and prominently in one of several ways (e.g., a sign in, on or adjacent to the vending machine, an electronic display).  Vending machines also must provide the vending machine operator’s contact information (name, telephone number, and mailing address or email address) on the face of the vending machine or with the calorie information (e.g., on a sign in, or, or adjacent to the vending machine).

When Must Covered Vending Machines Comply?

“Covered vending machine food” must comply by December 1, 2016.

Celebrating 35 Years of Success: USDA Practice Team

By Brett T. Schwemer

Recently, Olsson Frank Weeda Terman Matz, P.C., otherwise known as “OFW Law,” celebrated 35 years of business with colleagues, family, friends and clients.  We were extremely proud to share this milestone with those who have helped make OFW Law one of the leading firms practicing USDA and FDA law today.

Although OFW Law has expanded in other areas of law, the origin of OFW Law began in agricultural law and these roots remain strong today. Indeed, OFW Law is one of the most comprehensive agriculture law firms in the country, representing large and small companies and trade associations on a myriad of legal issues, ranging from food safety and nutrition, animal welfare and forestry, to everything in between. Together, our USDA practice team, consisting of 17 attorneys and Senior Policy Advisors, are capable of representing clients before virtually every agency of the USDA.  Our most frequent interactions involve the USDA’s Food Safety and Inspection Service (FSIS), Food Nutrition Service (FNS), Agricultural Marketing Service (AMS), Animal and Plant Health Inspection Service (APHIS), Grain Inspection, Packers and Stockyard Administration (GIPSA), Risk Management Agency (RMA) and Federal Crop Insurance Corporation (FCIC).

One attribute that makes the USDA practice team unique among its peers is its experience.  Many of our professionals have served in high level agricultural positions in the government and/ or have a long history of working in or with the agriculture/food industry   This has allowed our professionals to not only apply real world experience and technical expertise to solve difficult problems, but to identify the right contacts at USDA should issues need to be resolved at the Department.

The experience and expertise of our professionals have allowed the USDA practice team to tally many successes over the last 35 years.  We are proud to share a few of our most notable ones, as follows:

  • Our professionals have assisted numerous meat, poultry and other food clients design, implement and assess food safety, sanitation and quality control programs. With in-plant experience and training in HACCP principles, our professionals have helped clients not only comply with food safety requirements, but exceed them.
  • Our professionals have successfully assisted clients in FSIS enforcement actions (e.g., Notice of Intended Enforcement Actions, Notice of Suspensions), providing advice which has allowed clients to avoid, or minimize the duration of, plant closures.
  • Our practice team has helped numerous clients facilitate the marketing of their food and agriculture products, by assisting in obtaining government approval for new label claims and/or new ingredients/processing aids, or by helping to remove regulatory impediments for marketing their products. For example, we successfully petitioned FSIS to eliminate the standard of identity for pizza, giving frozen pizza manufacturers the flexibility to make more innovative products so they can better compete with pizzeria restaurant chains.
  • Our practice team has successfully defended meat packers, poultry slaughterers, livestock dealers and market agencies in numerous GIPSA enforcements actions under the Packers and Stockyards Act. In one case, GIPSA filed a complaint seeking over $3 million in civil penalties against a packer for failing to notify livestock sellers, prior to purchasing livestock, of a more accurate formula used for grading pork carcasses.   As a result of our representation of the packer, the Administrative Law Judge and Judicial Officer of USDA issued no civil penalties in the case.
  • Following a successful multifaceted campaign by our team, AMS rewrote the Florida Tomato Marketing Order in 2005 to permit the nationwide distribution of the UglyRipe® tomato during the regulated Florida tomato season.
  • When the Congress considered amendments to, and perhaps even repeal of, the Perishable Agricultural Commodities Act (PACA), stakeholders turned to our professionals for counsel. The amendments resulted in preservation of the fair trade statute covering all fresh and frozen fruits and vegetables with more efficient reservation of PACA Trust benefits and a stabilized funding mechanism for USDA’s PACA Branch.
  • Puerto Rico attempted to impose specific labeling requirements for shell eggs imported from outside the Commonwealth, including on the eggs themselves.  We successfully challenged the regulations in federal court at both the district and appellate levels, with the First Circuit holding that Puerto Rico’s regulation violated the Dormant Commerce Clause of the U.S. Constitution.
  • On FCIC Federal crop insurance, we have represented players on every side of the fast-growing program: approved insurance providers (AIPs), agents, farmers, product developers, and grower associations. In just one area, new insurance policies, we assisted in the approval of Livestock Risk Protection (LRP) for cattle, hogs, and lamb, margin protection for wheat and rice, oysters, barley, biotech corn, and many others. This past year, we assisted drought-hit farmers in Oklahoma and Texas on controversial claims, helped two insurance companies address oversight issues with RMA, and successfully urged changes in rules on treatment of indebted farmers.

This is a small snapshot of the long record that our group has assembled over the past 35 years, and we are very proud of it.

Consumer-Directed Promotions About Prescription Drugs: A Look Back at Print and TV Communications

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part VI)

By Tish Eggleston Pahl

In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to share some highlights throughout the years.  Parts I, II, III, IV and V focus on Hatch-Waxman, medical privacy laws, FDA’s user fees, prescription drug traceability and GMPs.  Today’s blog looks back at changes in the regulation of drug promotion.

As we celebrate anniversaries at OFW Law this month (the firm’s 35th and my 21st), any retrospective on the drug practice would be incomplete without recognizing our work on, and the changes to, how entities communicate with patients and consumers about prescription drugs.

We could go back to Lydia E. Pinkham’s Pills Vegetable Compound and earlier for evidence of “patent” drug promotion directly to consumers.  However, this retrospective begins in 1962, when Congress enacted the Kefauver-Harris Amendments to the FDC Act.  In addition to expanding FDA’s authority over prescription drugs, and requiring proof of safety and efficacy prior to approval and marketing, Congress also transferred from the FTC to FDA the authority over the advertising of prescription drugs.

Pursuant to that authority, in 1963, FDA initiated and finalized the rulemaking that would eventually become the familiar § 202.1 – Prescription-drug Advertisements (28 Fed. Reg. 1448 (Feb. 14, 1963); 28 Fed. Reg. 6375 (June 20, 1963).  The requirements that a prescription drug promotion be fairly balanced and accompanied by appropriate information (the full prescribing information (“PI”) for promotional labeling and a brief summary of that PI for advertising) have been with us – seemingly forever – and without substantial change.  If it seems that existing regulations don’t fit modern healthcare communications very well, look no farther than the fact that the regulations are older than both today’s popular technologies and most of the people who use them for prescription drug information.

FDA cites the early 1980’s as the point when prescription drug sponsors first began targeting patients and consumers directly – what became known as “direct-to-consumer” or “DTC” promotion.  FDA requested a voluntary moratorium on DTC prescription drug promotion on September 2, 1983 and, thereafter, undertook a series of public meetings and research.  The agency lifted the moratorium two years later (56 Fed. Reg. 36,677 (Sept. 9, 1985)), stating that it believed current regulations provided “sufficient safeguards” for consumers.

(Keep in mind, just getting copies of regulatory documents was an adventure in those days.  Paralegals with rolls of nickels and good contacts would traverse from the downtown Federal Register office to Fishers Lane and back, scrounging for documents put on public display.)

In August 1995, FDA announced the first of several public hearings on DTC-related issues (60 Fed. Reg. 42,581 (Aug. 16, 1995)).  Two questions FDA posed were of special interest: what information should accompany print promotion; and how to satisfy the disclosure requirements for broadcast advertisements.  Nearly 20 years later, these issues continue to vex prescription drug communications.

Accompanying Information in DTC Print Communications

Under 21 U.S.C. § 352(n), any print advertisement must be accompanied by “information in brief summary relating to side effect, contraindications, and effectiveness,” which FDA had interpreted in 21 C.F.R. § 202.1(e)(3)(iii) to mean “each specific side effect and contraindication” in the drug’s PI.

This meant that magazine and newspaper ads would include a page or more of solid text that reprinted most or all of the PI in a tiny font.  At the 1995 public hearing, then-FDA Associate Director for Medical Policy, Dr. Robert Temple, bluntly acknowledged that this approach for consumer-directed communications was an oxymoron:

Let’s say we all agree for the sake of argument that the current brief summary, which is neither brief nor a summary – like the Holy Roman Empire was neither holy nor an empire – isn’t very helpful.  I think you won’t find a great deal of disagreement about that among FDA staff either.

Unanimous condemnation of the PI-based brief summary in DTC promotion would continue through several more rounds of comments and FDA research that showed, unsurprisingly, that consumers found it no more useful than FDA staff did.

In 2004, FDA released the Brief Summary Draft Guidance which expressed the agency’s decision to exercise enforcement discretion and, the requirements of 21 C.F.R. § 202.1(e)(3)(iii) notwithstanding, permit and encourage abbreviated, consumer-friendly brief summaries with DTC print advertising.  Marketers implemented the draft guidance, hugely improving DTC print promotions.

Unfortunately, the agency never addressed what has, in the last 10 years, become an enormous problem in other patient-directed communications.  The Brief Summary Draft Guidance only helps DTC print advertising (e.g., magazines and newspapers) – media that are in significant decline.  The Draft Guidance does not apply to patient-directed labeling, like refill reminders and compliance and adherence communications given to patients to support their prescribed and dispensed therapy. FDA still interprets its requirements as mandating patient-directed labeling to be accompanied by the full PI, even though the agency has long acknowledged (and has the data to prove) that the PI isn’t helpful to patients.

Keeping patients compliant is an enormous, costly, and deadly public health problem and everything that can be done should be done to make these communications easier, better, and more accessible.  Since the release of the Brief Summary Draft Guidance in 2004, the agency has been urged, repeatedly, to do for patient-directed labeling what it did for DTC print advertising.  It never has.

In February, there was cause for hope when FDA’s Center for Drug Evaluation and Research (CDER) published its proposed Guidance Agenda and announced it would finalize the 2004 Brief Summary Draft Guidance.  This was good news, even if it would have little impact as so little DTC advertising remains in traditional print media and anyone still in that space adopted the consumer-friendly brief summaries years ago.  More exciting was the new title of the Guidance:

Brief Summary and Adequate Information for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs.

(Emphasis added.)  It appears that FDA may take the opportunity the guidance provides to address the heavy disclosure burden placed upon patient-directed promotional labeling that the DTC advertising does not have to meet.  Maybe, hopefully, compliance and adherence communications patients need for the safe and effective use of their prescribed and dispensed drugs can finally be accompanied by a useful, brief summary of the PI rather than the full PI.

“Adequate Provision” for DTC Broadcast Advertisements

That seminal 1995 DTC hearing also addressed the dilemma § 202.1 posed for prescription-drug broadcast advertising.  Under 21 C.F.R. § 202.1(e)(1), sponsors of broadcast advertisements are, among other things, required to present a brief summary in the advertisement or, alternatively, must make “adequate provision … for dissemination of the approved or permitted package labeling in connection with the broadcast presentation.”

This requirement made it impossible for manufacturers to promote DTC prescription drugs in regular broadcasts.  No one knew what “adequate provision” of the PI meant.  The brief summary was too long for the typical broadcast commercial, though advertisers would scroll through a drug’s brief summary or PI at the end of video presentations made at medical conferences – a measure that was as technically compliant as it was utterly useless.

In 1997, FDA issued a Draft Guidance on Consumer-Directed Broadcast Advertisements that explained how manufacturers could make “adequate provision” for the PI in a broadcast ad.  62 Fed. Reg. 43,171 (Aug. 12, 1997).  To satisfy adequate provision requirements, a prescription drug advertisement needed to identify several mechanisms describing where a consumer could obtain the product’s PI.  These included a toll-free number, a concurrent advertisement in a print publication, and an Internet URL.  The agency finalized the Guidance in 1999.

With this new clarity, TV prescription drug ads blossomed and have been highly controversial ever since.  FDA’s Office of Prescription Drug Promotion now has an extensive procedure for voluntary, pre-dissemination advisory review of both DTC TV ads and other materials.  In March 2012, FDA issued a draft guidance addressing when and how it would use its statutory authority under the FDA Amendments Act of 2007 to review prescription drug television advertisements prior to dissemination.  The guidance was highly controversial and FDA stated it would not begin pre-dissemination review until the guidance was final.  According to CDER’s agenda discussed above, this guidance is also slated to be released in final in 2014.

* * *

As we draw to the end of the year and continue celebrating OFW Law’s anniversary, we’re still waiting on the Brief Summary Guidance that will – we hope – resolve a problem that has vexed patient-directed compliance communications for decades.  If we do see the final guidance on pre-dissemination review of DTC TV ads in 2014, it should make for interesting reading given the vociferous objections to the draft guidance.  With so many marketers turning away from traditional media, we do wonder how much it will matter.  We’ll look at that next generation – prescription drug promotion in social media – in another retrospective coming soon.