Former Consumer Products Safety Commissioner Nancy Nord Joins OFW Law

We are pleased to announce that Nancy Nord, former Acting Chair of the United States Consumer Product Safety Commission, has joined OFW Law as Of Counsel.  Nord is a nationally recognized expert on safety regulation and corporate compliance with a wealth of experience in both the public and private sectors.

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Nancy Nord Announcement

May 19 Webinar on the Drug Supply Chain Security Act

Tish Eggleston Pahl will be speaking on May 19 at a webinar on dispenser obligations under the Drug Supply Chain Security Act (DSCSA).  The webinar is sponsored by the Healthcare Distribution Management Association (HDMA).  This “DSCSA Overview for Dispensers” continues HDMA’s education and outreach on the pharmacy and hospital–related implementation requirements under the DSCSA.  Particular focus will be on the data requirements for dispensers that go into effect on July 1 and also will address many of the questions that HDMA received during its previous April 21 webinar for dispensers.

Topics will include:

  • The loan or sale of medication from one dispenser to another;
  • The definition of “dispenser” and whether hospital and clinic pharmacies qualify;
  • Questions pertaining to suspect and illegitimate products;
  • Data that must be provided with the product, including questions about lot number and data pertaining to returned products;
  • Exempt products and transactions;
  • Questions around authorized trading partners and more.

The webinar is free.  More information about the webinar and how to sign up is available here.

Regulatory Round-Up Newsletter, Spring 2015

On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring newsletter.  We hope you find it useful.  To receive this periodic newsletter by e-mail, please contact Carrie Morgan at cmorgan@ofwlaw.com.

The Drones are Coming! FAA Releases Proposed Rule on Small Unmanned Aircraft Systems

By John G. Dillard

Mention the word “drone” and most people think of our nation’s military activities in the Middle East. However, over the last few years, unmanned aircraft is finding its way into new civilian applications. Small drones, which are also known as unmanned aerial vehicles (UAVs) or small Unmanned Aircraft Systems (sUAS), when equipped with sophisticated cameras, can be invaluable surveying tools.

Agriculture is one such industry that is particularly suited to benefit from drone technology. The rise of precision agriculture and prescriptive planting places a high premium on accurate, real-time data. Farmers and crop consultants have typically relied on satellite technology or images gathered by airplanes to assist their precision agriculture needs. UAVs equipped with multi-spectral cameras can deliver images that are much more precise than satellite data at a fraction of the cost of manned aircraft flight.

Many in agriculture are taking advantage of this technology. Farmers and crop consultants are using drones to monitor crop health, survey irrigation systems, and spot-check problem areas in fields that can often be missed by on-the-ground scouting. However, these UAV operators have been operating in what can most generously be described as a legal “gray area.” Since 2007, FAA has taken the position that any commercial use of unmanned aircraft is unlawful.

In 2012, Congress passed the FAA Modernization and Reform Act. One of the provisions of this Act required FAA to integrate unmanned aircraft into the national airspace system by September 30, 2015. The agency is taking an incremental approach to this mandate, and will certainly miss Congress’ deadline.

FAA’s first proposed rule on unmanned aircraft, “Operation and Certification of Small Unmanned Aircraft Systems,” was published in the Federal Register on February 23, 2015. The proposed rule would govern how sUAS (the agency’s preferred terminology) could be operated and the certification requirements for operators.  Major components of the proposed rule include:

  • Operation of sUAS. FAA proposes allowing the operation of sUAS flown within the visual line-of-sight of an operator. Operations must be conducted while maintaining a constant visual line-of-sight. Visual observers may be used to assist the operator in maintaining a visual line-of-sight, so long as the operator is capable of seeing the sUAS. sUAS may be operated with an altitude ceiling of 500 feet in unrestricted (Class G) airspace and with Air Traffic Control approval in some classes of restricted airspace.
  • Certification of sUAS operators. sUAS flights must be operated by a certified airman. FAA is proposing the creation of a sUAS rating for its existing airman certification program. Pilot licenses will not be required for sUAS operators. Certification will primarily be based on passage of an initial aeronautical knowledge exam. Operators will need to renew their certification every two years.
  • Registration and display of registration markings. FAA’s proposal requires sUAS to be registered with the agency. FAA also proposes to require sUAS to display their registration number.
  • Exemptions for airworthiness certificates. Section 332(b)(2) of the 2012 FAA Reauthorization Act enables FAA to consider whether the airworthiness certification requirements applicable to manned aircraft should also apply to sUAS. Based on the relatively lower risks that accompany sUAS, the agency decided to exempt sUAS from the airworthiness certification requirement.
  • Micro UAS. The agency is requesting comments on whether it should create a subclass of sUAS known as Micro UAS. Micro UAS would weigh less than 4.4 pounds and be subject to less stringent requirements for operating conditions and operator certification. Many agricultural drones would fall under this Micro UAS category.

To assist in understanding this rule and the potential implications for agricultural drone use, OFW has prepared a complimentary memorandum. This memorandum provides a comprehensive analysis of FAA’s proposed rule and how it will impact agricultural applications of UAV technology.

Click here for a free copy of OFW Law’s analysis of FAA’s proposed sUAS rule.

OFW Law Launches FDA DevicEd Training Initiative

OFW Law is proud to announce the launch of its FDA DevicEd Training Initiative.  The initiative is devoted to providing high quality FDA regulatory training to foreign and domestic medical device companies and the advisors who assist them.  Interactive in-person seminars will be developed and presented by OFW Law attorneys specializing in FDA regulation of medical devices.  These attorneys have a combined total of over 80 years of experience practicing FDA medical device law.

“The scope and complexity of FDA’s regulation of medical devices have only increased in recent years, with the swirl of new or revised statutory provisions and draft and final regulations and guidance documents growing all the time.  The OFW Law FDA DevicEd Training Initiative seeks to help device firms and their advisors navigate the often tricky FDA regulatory landscape in which they must conduct business or provide advice,” says Steve Terman, the head of OFW Law’s Medical Device Practice Group.

Besides communicating the regulatory information that companies and their advisors need, the initiative also is intentionally geared at providing practical insights which can be applied on a daily basis by company employees and firms in the medical device industry.  “While knowing what the law and guidance literally say is important, it doesn’t necessarily help you understand what they truly mean in practice so you can avoid regulatory pitfalls.  This is where the initiative can be of practical assistance,” says Neil O’Flaherty, an OFW Law principal attorney specializing in FDA device regulation.

The initiative will offer seminars for those new to the area of FDA medical device regulation as well as seminars targeting a specific area of FDA device regulation or a new regulatory initiative by FDA’s Center for Devices and Radiological Health.  The initiative also offers the opportunity for device firms and their advisors to work with OFW Law to develop and plan customized seminars to meet their specific needs.  “Not all firms need or want training and education on the same topics.  The OFW Law initiative allows them to design and implement training activities which are tailored to their interests and goals,” according to Evan Phelps, another principal attorney specializing in FDA device matters at OFW Law.

Trained and experienced professionals within and outside FDA are critical to a medical device industry which produces and markets safe and effective products.  OFW Law hopes its FDA DevicEd Training Initiative will be beneficial to industry professionals.

Please contact Neil O’Flaherty for more information about the OFW Law FDA DevicEd Training Initiative.

Please note that OFW Law FDA DevicEd Training Initiative sessions are for general informational purposes only.  They are not intended to and do not constitute legal advice and do not establish an attorney/client relationship.  Please contact an attorney and establish an attorney/client relationship if you need legal advice.

Dr. Nina Fedoroff Joins OFW Law as Senior Science Advisor

We are pleased to announce that Dr. Nina Fedoroff, a renowned plant molecular biologist, has joined OFW Law as Senior Science Advisor focusing on agriculture policy, global food security and government affairs.  The former Science and Technology Adviser to the Secretary of State, Dr. Fedoroff has long been involved in regulatory issues surrounding genetic modification of organisms (GMOs) by modern molecular techniques.

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Nina Fedoroff Announcement

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.

GMPs Have Long History That Precedes Application In Medical Products 1

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

By Neil P. Di Spirito

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, and IV focused on Hatch-Waxman, medical privacy laws, FDA’s user fees, and prescription drug traceability.  Today’s blog looks back at changes in drug GMPs over time.

After the Second World War, a group of young veterans developed a method to mix, process, and package bovine intestines in a manner that allowed surgeons to pack organs and stop bleeding.  The product, developed under a $1,500 government grant, proved useful beyond the veterans’ imagination.  From battlefield surgery to bloody noses sustained on college and playground football fields, the specific surface area configuration or form of the product stopped the blood from cuts and contusions.

When the veterans retired in the 1970’s, fading into the collective memories of history, this revolutionary medical advance almost faded with them.  Why?  How could an important medical product simply fade away with the inventors’ lives?  The art of making the product could not be replicated by the scientists and engineers who followed.  The inventors knew how to make the product, but the process had never been reduced to a verifiable and repeatable procedure.

Good Manufacturing Practices (“GMPs”) were developed in other industries prior to the FDA requiring their use in safe production of medical products.  The automotive, aviation, defense, and multiple other manufacturing industries all used GMP’s rigorous procedures with quality systems to assure their products performed as intended, according to specifications, 100% of the time.

To achieve this goal, manufacturing processes are “design-reviewed,” meaning they are formulated with subject matter expert and operational implementation personnel input, to maximize efficiencies in achieving product specification goals.  All materials and equipment are pre-qualified prior to their introduction into the assembly or service process, and point-of-process completion quality systems assure the product meets specifications prior to completion.

Medical products, both drugs and devices, did not initially require GMP production documentation, with the resultant failure to meet expected performance.

The well documented, inadvertent contamination of sulfa drugs with phenobarbital in 1941 (resulting in approximately 300 patient deaths), and failure to totally inactivate polio viruses in one vaccine batch in 1955 (resulting in approximately 60 inoculated patients developing the disease), led to the establishment of Federal GMPs Regulations for drugs (21 CFR Parts 210 and 211) and medical devices (21 CFR 820). In 1978, GMPs developed into the most rigorous of Good Manufacturing Practices.

The meticulous design-reviewed processes are only effective because they are required to be conducted under point-of-process completion quality systems by the entity utilizing the process, to assure the processes are completed as intended. Pre-qualification/validation of raw materials and required services before either are entered into the process, with review of the data at the time is acquired, provide control over the outcome quality.

*Certain parts of this blog were adapted from a Policy Forum article written by Neil DiSpirito and Anton Usala.

26 Years, With 9 To Go…. 35 Years to Prescription Drug Traceability 2

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

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, and III focused on Hatch-Waxman, medical privacy laws, and FDA’s user fees, respectively.  Today’s blog looks at the evolution of prescription drug traceability and tomorrow’s blog will discuss drug GMP requirements.

The ability to track the commercial life of a finished prescription drug, from the point at which it leaves the manufacturer to the point at which it is dispensed or administered to a patient, has proven elusive.  Congress intended for The Prescription Drug Marketing Act (PDMA) to reduce the risk of counterfeit, adulterated, misbranded, subpotent, or expired drugs being sold to patients.  President Reagan signed the PDMA into law on April 22, 1988; yet, twenty-five years later, the PDMA was never fully implemented and it is only with last year’s passage of Title II of the Drug Quality and Security Act, the Drug Supply Chain Security Act (DSCSA), that the goals of the PDMA will, eventually, be realized.

The PDMA sought to achieve its lofty, public health goals through a variety of means.  It provided for FDA’s establishment of minimum standards for the licensing by State authorities of wholesale distributors of prescription drugs.  The State wholesale distributor licensing provisions of the PDMA were implemented in a final rule, 21 C.F.R. Part 205.

The PDMA also banned the sale, purchase, or trading of drug samples and established requirements for drug sample distribution, storage and handling.  It further restricted the re-importation of prescription drugs and prohibited, with certain exceptions, the sale, purchase, and trade of prescription drugs purchased by hospitals or other health care entities, or donated or supplied at a reduced price to charities.  FDA promulgated final regulations to implement these provisions of the PDMA.  21 C.F.R. Part 203, Subparts B, C, and D.

The PDMA also sought to require unauthorized wholesale distributors – frequently referred to as “secondary wholesalers” – to provide purchasers with a statement (a “pedigree”) that identified each prior sale of the drug.

It was here that the PDMA floundered.

FDA promulgated a final rule, codified at 21 C.F.R. § 203.50(a), that implemented these requirements.  64 Fed. Reg. 67,720 (Dec. 3, 1999).  Amid public outcry, FDA stayed the rule until October 1, 2001, and then, until April 1, 2002 . . . and several more times thereafter.  Finally, in June 2006, FDA announced it would not further delay implementation and § 203.50(a) would go into effect on December 1, 2006.  71 Fed. Reg. 34,249 (June 14, 2006).

On September 20, 2006, a group of unauthorized wholesaler distributors sued FDA seeking, among other things, a declaratory judgment that § 203.50(a) erroneously interpreted the PDMA’s pedigree requirement.  RxUSA Wholesale, Inc. v. HHS, 467 F. Supp.2d 285 (E.D.N.Y. 2006).  The plaintiffs eventually prevailed and halted FDA’s implementation of 203.50(a).  In 2011, FDA withdrew the regulation.  76 Fed. Reg. 41,434 (July 14, 2011).

In the Federal Register notice announcing the withdrawal, FDA reiterated that it wasn’t giving up:

[We] will continue to move forward, working with the private and public sectors to improve the security of the drug supply chain and implement measures to further protect Americans from counterfeit and diverted drugs.

[S]uch measures include implementation of tracking and tracing, which would help secure the integrity of the supply chain by providing an accurate electronic record of transactions in the drug supply chain. Such electronic records documenting the movement of a drug product from the manufacturer to the dispenser would be an important step in preventing counterfeit and diverted drugs from entering the drug supply chain.

76 Fed. Reg. at 41437.

In November 2013, a coalition of drug supply chain stakeholders, working closely with FDA and Congressional staff, achieved the passage of the next stage of the PDMA, the DSCSA.  Over the next ten years (now nine), FDA along with manufacturers, distributors, dispensers, repackagers, and third-party logistics providers, will work to develop an electronic system for the exchange of information about individual packages of prescription drugs.  The system that will allow for the identification and tracking of where a drug has been in the supply chain.  Important provisions of the law include:

  • Affixing a unique, machine-readable identifier on each prescription drug package;
  • The exchange of information between trading partners about the drug each time it changes ownership in the supply chain;
  • Establishment of systems for the verification of product identifiers;
  • Establishment of systems for identification of, responding to, and notifications regarding, suspect and illegitimate product in the supply chain;
  • Wholesale distributor reporting of licensure status; and
  • Licensing of third-party logistics providers.

The first significant DSCSA milestone arrives January 1, 2015, when manufacturers must provide data about each product transaction and wholesale distributors must receive and be able to transmit that data.

For those of us who have been with this from the beginning, the path to product traceability has been rife with false starts and delays.  Now, the DSCSA gives the supply chain and FDA a roadmap to achieving that goal.  It will be a 35-year journey, but the end is in sight.