OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part I)
Since its inception in 1979, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practices have focused on myriad regulatory issues arising under FDA and broader HHS jurisdiction. We advise clients on matters ranging from Hatch-Waxman and generic drug marketing exclusivity issues, ANDAs and 505(b)(2) NDAs, to HIPAA/HITECH medical privacy matters, controlled substance laws and regulation, GMPs, drug distribution, marketing and promotion, and a variety of associated compliance and enforcement issues.
Over the next several days, we will take a look back at the last 35 years and share some of the highlights of our drug practice.
Part I: Thirty Years of Hatch Waxman
Thirty years ago, Congress passed the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (formally known as the Drug Price Competition and Patent Term Restoration Act of 1984) and recognized two important public policy goals at the heart of the generic drug approval process. First, the legislature sought to ensure that brand-name drug manufacturers would receive patent protection and marketing exclusivity that would allow them to recoup their significant investments in the research and development of innovator drugs. Second, at the conclusion of the innovator’s patent protection and marketing exclusivity, patients would have access to lower-priced generic versions of those brand-name drugs.
Hatch-Waxman allows FDA to approve a generic drug based on an “abbreviated application” that demonstrates that the generic product is equivalent to the brand or innovator drug product being copied, without repetition of laboratory animal safety studies and human clinical trials that support the approval of the brand drug. Before Hatch-Waxman, FDA would consider an abbreviated application only for a copy of a brand drug product first approved before 1962. The consequence was that very few generic versions of most newer brand name prescription drugs were available.
OFW Law has been central to the development of Hatch-Waxman regulatory implementation and jurisprudence over the past several decades.
Because generic drugs are commodity products for the most part, early entry into the marketplace is often a key factor in commercial success. Unfortunately, during the early days of Hatch-Waxman, some less-than-honorable individuals tried to achieve early market entry for their drugs through unlawful acts, such as giving items of substantial value to key FDA staff to have their generic drug applications reviewed out of sequence or submitting fraudulent data to FDA in their applications, helping ensure approval in the first review cycle. These activities combined to form what often is called the “generic drug scandal” of the late 1980s and early 1990s. In response to the “scandal,” debarment, civil penalty, and additional withdrawal of approval provisions were added to the FDC Act in 1993.
In the 1990s, most activity centered on the substantive conditions of FDA approval, such as whether the generic product and its brand counterpart have the same active ingredient, dosage form, or labeling, or whether the generic is bioequivalent to its brand counterpart. The courts upheld practically all FDA decision-making in these areas.
Hatch-Waxman provides for 180 days of marketing exclusivity, under which the first generic drug applicant to challenge a patent on the brand product being copied gets a statutory 180-day “head start” over its generic competition. Until 1998, 180-day exclusivity was very seldom rewarded. In 1998, however, the D.C. Circuit rejected FDA’s former “successful defense” regulation, under which a “first” generic applicant had to have prevailed in patent litigation to be eligible for 180-day exclusivity. See Mova Pharmaceutical Corp. v. Shalala, 140 F.3d 1060 (D.C. Cir. 1998). After Mova, 180-day exclusivity typically was associated with generic versions of every brand-name product for which there was an associated patent challenge. Mova really opened the flood gates and the generic drug world found itself awash in 180-day exclusivity disputes and litigation during much of the first decade of this century. Although Congress made fundamental changes to 180-day exclusivity in the Medicare Modernization Act of 2003, that only led to more disputes and litigation.
Today, the generic drug industry has grown and matured from its humble beginnings with annual U.S. savings from generic prescription drugs totaling in the many billions of dollars. The current frontier for “generic” pharmaceutical competition is drug products of biological, rather than synthetic chemical, origin. The Biologics Price Competition and Innovation Act of 2009, modeled loosely on Hatch-Waxman in many respects, created a regulatory pathway for FDA approval of such “biosimilars.”
The top two selling prescription drugs in the world are AbbVie’s Humira (adalimumab) and Johnson & Johnson’s Remicade (infliximab), expensive preparations indicated for the treatment of Crohn’s Disease, arthritis, and similar conditions. Biosimilar infliximab and adalimumab appear to be on the fast track. It is just a matter of time before this new frontier opens a broad new Hatch-Waxman-like chapter in federal generic drug approval regulatory implementation and jurisprudence.
Keep an eye out for tomorrow’s blog, “HIPAA Comes of Age,” which reviews the growth of the medical privacy landscape.
Note: This blog post was adapted from our September 24, 2014 posting, “Hatch-Waxman Turns 30 – A Stroll Down Memory Lane,” by Arthur Y. Tsien.
