Mobile Medical Application Guidance From FDA is Coming

By Mason Weeda

“[Final guidance] should be out by the end of the fiscal year” said Christy Foreman, Director of the Office of Device Evaluation, in her testimony before the House Oversight and Investigations Subcommittee on March 21, 2012. Ms. Foreman’s testimony can be viewed at the committee website, here.

In July 21, 2011, FDA released draft guidance to clarify the types of mobile apps to which FDA intends to apply its authority.  Therein, FDA defines a “Mobile Application” as “a software application that can be executed (run) on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.”  A “Mobile Medical Application” is defined as a Mobile Application that meets the definition of a “device” in the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 321) and either is used as “an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device.”  Although FDA touts its draft guidance as “narrowly tailored,” as demonstrated by the 131 comments received, industry begs to differ.  Nearly two years later, FDA has yet to issue final guidance.

Industry testimony at the March 21 hearing was consistent – final guidance is necessary to quell regulatory uncertainty.  Most witnesses appeared to have a sense of urgency, which is understandable considering that there are 27,000 mobile health applications (and 500 new apps per month).  Bradley Thompson, general counsel for mHealth Regulatory Coalition, remarked that, without final guidance, business “is frozen on the sidelines waiting.”  Moreover, the industry witnesses agreed that the draft guidance is unclear because it does not focus on types of mobile applications that it will regulate or even which applications will require a pre-market approval.

Ms. Foreman’s testimony added little information beyond that which is available in the draft guidance. She recognized and reiterated the definition of Mobile Medical Application in the draft guidance, presumably indicating that there will be no change in the definition.  She did, however, offer some Agency insights, stating that “FDA’s proposed mobile medical apps policy would not”:

  • regulate the sale or general consumer use of smartphones or tablets;
  • require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes; nor
  • apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system.

The above information may not be seen as helpful by many stakeholders.  In comments to the proposed rule, many stakeholders seem more interested in what will be regulated, as opposed to what will not be regulated.  Although there was no further elaboration on what will be regulated, Ms. Foreman recognized that “clarity” is necessary for industry and “final guidance will provide additional clarity and examples.”  Further the final guidance will “refine” FDA’s approach and further “narrow” the regulatory scope.

Ms. Foreman also touted the efficiency of FDA’s 510(k) process, stating that based on “performance over past three years, all mobile apps reviewed in the 510(k) process averages 67 days.” Yet, since 1997, FDA has only had one-hundred Mobile Medical App 510(k) submissions.

Although Ms. Foreman’s testimony added little to the public record, there is still hope for industry that, perhaps, the final guidance will “fill in the blanks”  to end the paralyzed state of regulatory uncertainty.

FTC Offers Updates Guidance on Social Media; Still Waiting on FDA

 

By Tish Eggleston Pahl and Mason Weeda

At the end of 2012, 850 million users worldwide were on Facebook, more than one million websites have integrated with Facebook and 34 percent of U.S. marketers have generated leads using Twitter.  You can see more social media statistics at the Huffington Post here.  Guidance on legal compliance moves far more slowly than the innovation which spawns the need for that regulation.  The Federal Trade Commission (FTC) has been at the forefront in shaping policy for online marketing and bringing enforcement actions against marketers for non-compliance; however, the Food and Drug Administration (FDA) has lagged behind, having offered little guidance concerning online marketing.

Over ten years ago, the FTC issued guidance to marketers on how consumer protection laws apply to online advertising and sales and explained how marketers could clearly and conspicuously present required disclosures and disclaimers in online advertising. On March 13, the FTC updated this advice in its .com Disclosures guidance to provide additional information on how marketers can truthfully and lawfully market their products to consumers online.  In the meantime, we continue to wait for FDA to issue social media guidance, a process begun in 2009.  Fed up with the delay, in the Food and Drug Administration Safety and Innovation Act, Congress ordered FDA to issue social media guidance by July 2014.

An ongoing concern for pharmaceutical marketers has been FDA enforcement actions requiring that all online promotion comply with the requirements applicable to traditional print promotions.  Specifically prescription drug promotions that include the drug name and other information about the drug, such as its indication, must also include a fairly balanced presentation of risk information in proximity to the benefit information.  Including this so-called “fair balance statement” in the body of many online promotions is impossible – a prescription drug’s fair balance statement cannot fit in a 140-character Tweet, a Facebook post, or a sponsored link.  Regardless of the technological infeasibility, FDA issued a slew of enforcement letters in April 2009 to pharmaceutical manufacturers who had been run Google short text ads (the ads that run beside Google search results) that included the drug’s name and indication with hyperlinks and click-through to pages that provided the required disclosure of risk information.  Examples of the FDA enforcement letters are here and here.  A persistent hope has been that when FDA finally does issue its social media guidance, it would permit hyperlinks to fair balance statements rather than requiring the inclusion of the lengthy statement in the body of the online advertisement.

However, if FDA looks to the FTC .com Disclosures guidance for advice as it drafts its own social media guidance, the prospect of abandoning the old model and moving to a click-through model for provision of a prescription drug’s risk disclosures doesn’t look favorable.  In the FTC’s .com Disclosures guidance, as expected for an agency with long experience in the area, the FTC proves to be savvy and conscious of the limitations posed by Twitter and other space-constraining media.  The FTC allows for the use of hyperlinks “when a space-constrained ad requires a disclosure.”

If the FTC would have stopped here, pharmaceutical marketers might have been one step closer to a click-through model for prescription drugs.  However, the FTC guidance also states that any disclosure that is an “integral” or “inseparable” from a claim “should not be communicated through a hyperlink.” See p. 10The guidance goes on to state, that “this is particularly true for cost information and certain health and safety disclosures.”

If FDA continues to adhere to its current position, and adopts the FTC’s view, it will be effectively impossible for pharmaceutical manufacturers to include basic information about a prescription drug in limited space social media platforms.  The irony is that unlawful, foreign website marketers, illegal off-shore pharmacies, and other similar sites will be able to continue to seemingly provide useful, basic information, such as what disease a drug treats, while pharmaceutical marketers, whose website promotions are regulated and closely scrutinized by FDA, will not be able to provide even this information in the social media sites consumers and patients are using.

Congress Clears Final Agriculture/FDA Spending Measure for FY 2013

By Roger R. Szemraj

The House of Representatives and Senate have now given final approval to the FY 2013 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill (the Bill) as part of a combined multi-Department omnibus measure, clearing it for the President’s expected signature.  The current Continuing Resolution expires on March 27, 2013.   The Bill provides $984 billion in total spending, in line with post-sequestration requirements.

The House had on March 6 approved H.R. 933, the Department of Defense, Military Construction and Veterans Affairs, and Full-Year Continuing Appropriations Act, 2013.  The Senate, as part of its substitute for H.R. 933, included Division A, which effectively serves as a joint agreement reconciling the FY 2013 Agriculture Appropriations bills reported by the House and Senate last year, but never acted upon by the full chambers.  Provisions that were in both the House Report (H.Rpt. 112-542) and Senate Report (S.Rpt. 112-163) remain unchanged except as may have been modified in the accompanying Explanatory Statement.

The legislation provides $139.460 billion in both mandatory and discretionary funding.  This is an increase of about $2.62 billion over FY 2012.  The mandatory funding in the Bill is $118.928 billion, of which more than $97.181 billion goes for food assistance programs including the Supplemental Nutrition Assistance (SNAP, previously Food Stamps) Program and the Child Nutrition Programs.  Discretionary spending will be $20.532 billion in FY 2013, an increase of nearly $1 billion over FY 2012.

While there has been discussion of whether or not this appropriations bill would be used to replace sequestration or to provide some flexibility regarding how sequestration would be applied, no broad action with respect to sequestration was taken.  Instead, specific efforts were made to mitigate sequestration for certain programs:

  • The Pryor-Blunt amendment supplemented funding for the Food Safety and Inspection Service (FSIS) by transferring funds within the Agriculture portion of the Bill to offset sequestration and, as a result, avoid the projected furloughs of meat inspectors.
  • An increase was provided for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to offset sequestration.  FY
  • The Senate provides an additional $12.8 million not included in the House bill for the implementation of the Food Safety Modernization Act.
  • The Senate provides an additional $250 million not included in the House bill for rural water programs.

To finance some of the above and other modifications included in the Bill, an across-the-board reduction in discretionary spending of 2.513% for non-security programs and 0.092% for security programs is included.  As a result, this means that there are some programs within USDA that lose 5.1% due to sequestration, and an additional 2.513% due to the reductions in H.R. 933 as amended.

New AMS Proposed Rule for COOL Drives Meat Industry Mad

By Barbara J. Masters, D.V.M.

While most people are filling out their brackets for March Madness®, producers of muscle cuts of meat are dealing with a different type of “March Madness.”  On March 12, 2013, in response to a World Trade Organization (WTO) ruling that the current U.S. country of origin labeling (COOL) requirements for muscle cut meat discriminate against Canadian and Mexican imports and that the U.S. must rectify this by May 23, 2013, the Agriculture Marketing Service (AMS) published a proposed rule to amend its COOL regulations.  Unfortunately, not only is the industry unclear how the proposed rule would comply with the WTO ruling, but the industry is extremely concerned that the proposed rule would only make the labeling requirements for the meat industry even more burdensome and costly.

Under the proposed rule, producers of muscle cuts of meat would have to identify on their labels the country or countries where each production step occurs, including that of birth, raising, and slaughter of the animal for which the muscle cut was derived.  This would be required for meat from all countries including the United States.  For example, a muscle cut of meat that is from an animal born, raised and slaughtered in the United States would have to be labeled as, “Born, Raised and Slaughtered in the U.S,” as opposed to the current labeling requirement of, “Product of the U.S.”  This change alone could be extremely costly to U.S. producers.

Another costly and burdensome requirement of the proposal would be to eliminate any commingling of the muscle cut commodities originating from different countries that is currently allowed under the regulations.  For example, a label today can bear a country of origin statement such as, “Product of the United States, Country X and Country Y.”  However, this designation would not be permitted under the proposal, as the label would be required to specify where the animal from which the muscle cut was derived was born, raised and slaughtered, and this would not be possible if commingling occurred.

In addition to the example provided above for animals born, raised and slaughtered in the U.S., other examples of labels based on the proposal would include:

  • For animals born in another country and raised and slaughtered in the United States, the label would be modified from, “Product of the U.S. and Country X” to “Born in Country X, Raised and Slaughtered in the U.S.”
  • For animals imported for immediate slaughter, the labels would be modified from “Product of Country Y, Slaughtered in the U.S.” to “Born and Raised in Country Y, Slaughtered in the U.S.”

The economic impact of the proposed COOL requirements would undoubtedly be significant to the meat industry.  AMS estimates that the label changes alone could cost the industry between $16,989,000 to $47,326,500.  However, this may only be a fraction of the cost, as the agency has not taken into consideration the impracticality and cost of segregating animals of different origins at slaughter in order to comply with the proposed labeling requirements.  Comments, including projected costs, are being requested and must be received no later than April 11, 2013.

The Economic Report of the President on Agriculture

The 2013 Economic Report of the President, an annual report written by the Chair of the Council of Economic Advisers, was released on Friday, March 15.  An important vehicle for presenting the Administration’s domestic and international economic policies, the report provides an overview of the nation’s economic progress.  This year, it includes a chapter on agriculture, which can be found here, “Chapter 8: Challenges and Opportunities in U.S. Agriculture.”  It concludes:

“The President believes that a vibrant U.S. agricultural sector is vital for the Nation’s prosperity…Persistent gains in efficiency have defined American agriculture and nearly tripled farm productivity in the second half of the twentieth century. To continue this tradition and maintain the strength of the sector, the Nation must continue to invest in agricultural R&D, helping farmers find new ways to grow more with less and to continue their stewardship of natural resources for future generations. The agricultural sector is increasingly vulnerable to price volatility because of the globalization of agricultural commodities, volatile weather conditions as a result of climate change, and changing consumption patterns. To cope with these challenges, U.S. agriculture must stay at the forefront of agricultural innovation.”

What Kind of Control Over What We Eat and Drink Is Permissible in Our Democracy?

By Michael J. O’Flaherty

Earlier this week, the New York State Supreme Court, New York County, in an opinion of the Honorable Milton A. Tingling, JSC,  enjoined and permanently restrained New York City (NYC) from implementing NYC Health Code § 81.53, commonly referred to as the “Portion Cap Rule” for sugary sodas, a regulation supported by Mayor Richard Bloomberg that would have become effective March 12 (with a 3 month grace period before enforcement).

The regulation, an anti-obesity measure, essentially would have prohibited restaurants, mobile food carts, delis, and concessions at movie theaters, stadiums, or arenas from selling sugary drinks in cups or containers larger than 16 fluid ounces.  Businesses that violated the law would have faced an initial $200 fine.

Judge Tingling ruled that NYC’s Board of Health, appointed by the mayor, does not have the power to “limit or ban a legal item under the guise of ‘controlling chronic disease,’” finding that the NYC Council, the city’s legislature, “alone has the authority to legislate as the Board seeks to do here.”  His opinion deemed the proposed rule “fraught with arbitrary and capricious consequences,” noting that “the court finds that the regulation herein is riddled with exceptions based on economic and political considerations.” The regulation did not apply to certain types of dairy products (e.g., milk shakes) and drinks containing more than 50 percent milk. Also, it applied only to businesses regulated by the city, and not to businesses, such as convenience stores and grocery stores, which are regulated by the state.

NYC reportedly plans to appeal the decision, so we will monitor how this particular matter is resolved.

More generally — and prospectively — the case highlights and will set a significant precedent for an important issue: What kind of control over what we eat and drink is permissible in our democracy?  For example, aside from NYC’s attempt to regulate portion sizes for sugary drinks, what ingredients (e.g., GMOs, already subject to initiatives in several states) and nutrients (e.g., calories, trans fat) properly may be regulated?  Is consumer interest or a health concern sufficient regulatory basis?  What authoritative body (e.g., legislature, administrative agency) should take the lead?  Are bans versus mandatory label declarations versus voluntary claims appropriate?  May specific venues (e.g., fast food restaurants, convenience stores near schools) be targeted?

These questions are interactive and complex and, together with the NYC case, forecast much ahead in the food regulatory arena.

Ag Portion of FY 2013 CR: Explanatory Statement

Click here for the explanatory statement accompanying the agriculture portion of the Senate’s Continuing Resolution (CR), which was released Monday night and includes  the Agriculture appropriations bill.  It contains language similar to a Conference Report in that it incorporates by reference items from the House and Senate reports, while highlighting certain items.  The Senate CR is a substitute for the House-passed measure (H.R. 933), which did not have line-by-line Agriculture and FDA numbers.

FDA Cancels Registrations of Food Facilities That Were Not Renewed in Time 1

By Robert A. Hahn

Some foreign food makers have recently found themselves unceremoniously purged from FDA’s database of registered facilities, and their products stopped at the port.

Under the Food Safety Modernization Act (FSMA), all food facilities required to register with FDA must renew their registrations every two years, during the fourth quarter of every even-numbered year.  The first registration renewal period ended December 31, 2012, but was extended by FDA until January 31, 2013.  Food facilities that did not renew their registrations in time have had their registrations invalidated by FDA and will need to complete new registrations and obtain new registration numbers.

Apparently, a significant number of foreign food facilities were unaware of the new requirement to renew their registrations and were caught off guard.  According to U.S. Customs and Border Protection (CBP), FDA is in the process of modifying the registration status of these facilities to “invalid.”  Beginning on February 1, 2013, CBP began to hold or reject shipments of food from foreign facilities with invalidated FDA registrations.

This can be easily corrected by the facilities involved.  In the meantime, domestic companies may wish to check to make sure their foreign suppliers’ FDA registrations are in good standing, or even request proof of registration from their foreign suppliers.

School Nutrition Update

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

School nutrition is front and center these days. At the USDA Outlook Conference, Secretary Vilsack proudly pointed out the many improvements USDA has made to school nutrition programs as well as other nutrition programs.

The National School Lunch Act (the Act), signed into law by President Truman in 1946, is widely seen as one of the most successful federal programs. The idea then – and now – is that all schools should have the ability to offer lunch and breakfast to students so that they can concentrate on school work, and not be distracted by hunger.

Today, lunch is served to over 31 million children in 100,000 schools. The US program is a model being replicated all over the world from Japan to Ghana.  The program is also big business.  By one estimate, over ten percent of all food away from home is now served in school.

New School Meal Standards…The nutritional standards for school lunch were significantly changed for the current school year, and more changes are coming for the breakfast program.  Some believe that this new rule was a result of the enactment of the Healthy, Hunger-Free Kids Act of 2010. That is not the case.  In fact, these changes had been in process for many years, and are the first significant nutrition update in more than a decade.

Click here to read this article in its entirety.