FDA Approval of Generic Biologics: Finding a Regulatory Pathway

Michigan Telecommunications and Technology Law Review Volume 14 | Issue 1 2007 FDA Approval of Generic Biologics: Finding a Regulatory Pathway Kathleen R. Kelleher University of Michigan Law School Follow this and additional works at: http://repository.law.umich.edu/mttlr Part of the Administrative Law Commons, Food and Drug Law Commons, and the Legislation Commons Recommended Citation Kathleen R. Kelleher, FDA Approval of Generic Biologics: Finding a Regulatory Pathway, 14 Mich. Telecomm. & Tech. L. Rev. 245 (2007). Available at: http://repository.law.umich.edu/mttlr/vol14/iss1/8 This Note is brought to you for free and open access by the Journals at University of Michigan Law School Scholarship Repository. It has been accepted for inclusion in Michigan Telecommunications and Technology Law Review by an authorized editor of University of Michigan Law School Scholarship Repository. For more information, please contact . NOTE FDA APPROVAL OF GENERIC BIOLOGICS: FINDING A REGULATORY PATHWAY Kathleen R. Kelleher* Cite as: Kathleen R. Kelleher, FDA Approval of Generic Biologics: Finding a Regulatory Pathway, 14 MICH. TELECOMM. TECH. L. REV. 245 (2007), availableat http://www.mttlr.org/volfourteen/kelleher.pdf Biologics are becoming increasingly importantfor the potential treatment of widespread diseases such as cancer, anemia, and diabetes. As hundreds of biologics are going off-patent, the market has become ripe for the introduction of generic biologics. A regulatory pathway for biogenerics, however, is virtually nonexistent. The purpose of this paper is thus to analyze how a successful legislative pathway for generic biologics might be designed. The current regulatory scheme, economic concerns, health and safety concerns, and the need to provide proper incentives for innovation are analyzed. Finally, recent Congressional bills are outlined and critiqued, through which the structure of a successful pathway for biogeneric approval can be understood. IN TRODU CTION ...................................................................................... I. BIOLOG ICS ................................................................................ II. CURRENT REGULATORY FRAMEWORK ..................................... A. Public Health Service Act vs. Food, Drug, and Cosmetic A ct............................................................... B. Hatch-Waxman 505(j) ....................................................... C. Hatch-Waxman 505(b)(2).................................................. III. * 246 247 248 248 249 L EGISLATION ............................................................................ 250 25 1 A. Needfor New Legislation.................................................. B. Economic Concerns........................................................... C. Health and Safety Concerns.............................................. D. Hatch-Waxman Lessons..................................................... 251 252 254 255 1. New Chemical Entity Exclusivity ............................... 255 J.D., expected May 2008, University of Michigan Law School; M.Eng., 2005, Materials Science and Engineering, Massachusetts Institute of Technology; S.B., 2004, Materials Science and Engineering, Massachusetts Institute of Technology. Many thanks to Professor Rebecca Eisenberg for her help with this Note. 246 Michigan Telecommunications and Technology Law Review [Vol. 14:245 2. 30-M onth Stay ................................... 256 3. 180-Day Generic Exclusivity .......................... 257 IV. E. EuropeanApproach...................................... 258 CURRENT CONGRESSIONAL BILLS ............................ 259 A . B ill Sum m aries ...................................... 259 B. ProposedImprovements to Bills ........................... 261 CONCLU SION ................................................ 263 INTRODUCTION Biologics are an important part of America's health care system today. They are used for the treatment of such serious or life-threatening diseases as lung cancer, colorectal cancer, diabetes, and anemia.' So far, over 150 new biologics have been approved by the FDA, which have provided care for over 325 million patients.2 The FDA, however, has long been reluctant to approve generic biologics. As early as 1974, the FDA emphasized that every biologic must go through rigorous clinical trials before approval because "all biological products are to some extent different and thus must be separately proven safe, pure and effective.... There is no such thing as a 'me-too' biologic. 3 Such reluctance has become more apparent today as hundreds of biologics are going off patent, but only a handful of generic biologics have been approved. At the heart of the FDA's reluctance to approve generic biologics is the inherent difficulty in determining whether generic biologics are as safe and effective as their pioneer counterparts. As the FDA struggles to find safe and effective generic biologics, however, the average cost of critical biologics continues to soar at a rate far surpassing that of traditional drugs. The challenge is thus to find a way to get biogeneric products approved while still maintaining the safety and efficacy standards set forth by the FDA. This paper will explore the generic biologic market, the challenges associated with the current regulatory framework, and how a successful legislative pathway for generic biologics might be designed. 1. Backgrounder on Biologics, http://www.waxman.house.gov/pdfs/summarygenericjbiologics_9.29.06.pdf (last visited Oct. 18, 2007). 2. 3. Id. Wayne. H. Matelski, Generic Biologics: Outline of Legal and Regulatory Issues, 760 PRACTICING L. INST. PATS. COPYRIGHTS TRADEMARKS & LITERARY PROP COURSE HAND- BOOK SERIES 291, 300 (2003) (quoting Preamble to FDA's Final Regulations Implementing the Freedom of Information Act, 39 Fed. Reg. 44,602 44,641 (Dec. 24, 1974)). 4. See David M. Dudzinski, Reflections on Historical, Scientific, and Legal Issues Relevant to Designing Approval Pathwaysfor Generic Versions of Recombinant Protein-Based Therapeutics and MonoclonalAntibodies, 60 FOOD & DRUG L.J. 143, 199 (2005). 5. See Backgrounder on Biologics, supra note 1. Fall 2007] FDA Approval of Generic Biologics I. BIOLOGICS Biologics are complex substances that are derived from living sources. Defined under the Public Health Service Act (PHSA), a biological product is characterized as "a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. ' '6 Examples of biologics include insulin, some vaccines, and monoclonal antibodies, which can be useful for the treatment of cancer, anemia, diabetes, hepatitis, and multiple sclerosis.' Biologics are (...truncated)