The American Conference Institute (“ACI”) will hold (virtually) its 4th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA from October 8-24, 2024.  This virtual three-week program is designed to give new lawyers and executives a solid foundation in the essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation. Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials—critical competencies for legal and business professionals in the biopharmaceutical sector.  Everyone in the life sciences industry must be well-verse ..read more

By John W.M. Claud ..read more

By John W.M. Claud & JP Ellison — The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the Agency’s interpretation of ambiguous statutory provisions. Stripping FDA of the key tool of deference, Loper Bright will undoubtedly reinvent the way FDA advocates in federal courts. The majority opinion in Loper Bright finds that this is a necessary c ..read more

By Sara W. Koblitz — In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars.  For the last 14 years, an applicant could get approval of a biosimilar as a standard biosimilar or an interchangeable biosimilar, but the interchangeable biosimilar presented a higher hurdle to approval: Applicants needed to show that a patient could be switched from the Reference Product to the biosimilar and back without issue.  But, as time has marched on and FDA’s experience with interchangeable biosimilars grown, the Agency’s ..read more

By Sarah Wicks & Dara Katcher Levy — On April 24, 2024, the FDA issued a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products – Questions and Answers, (the “Revised Draft Guidance”) which replaces the Agency’s initial draft guidance issued in February 2020 (the “Initial Draft Guidance”). This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar produ ..read more

By Sara W. Koblitz & Kurt R. Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA.  This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010.  Amongst other things, FDA co-opted many of the same definitions for key terms for implementation of the BPCIA.  Relevant here, FDA interpreted i ..read more

By Sara W. Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”).  As has been explained, the BPCIA provided an abbreviated pathway to market for follow-on biologics—biosimilars and interchangeable biosimilars—and with that pathway came two types of exclusivity periods: one for the “Reference Product” to encourage continued innovation and one for the “First Interchangeable” biosimilar to encourage the development of biosimilars that could be s ..read more

By Mark A. Tobolowsky — FDA, like much of the rest of the world, has been adjusting to the rapid changes in our world these last few years.  For nearly three years following the declaration of the COVID-19 health emergency, there were no in-person meetings held.  Then, in early 2023, CDER and CBER started a slow phase-in of in-person meetings in a hybrid format, with some attendees present only virtually.  The hybrid format was necessary due to limitations in the number of attendees who could be accommodated in-person in the handful of newly revamped meeting rooms.  At firs ..read more

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials AND a critical competency for legal and business professionals in the biopharmaceutical arena AT THE American Conference Institute’s (ACI’s) 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA! Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series from October 10-26, a virtual three-week program designed to provide new lawyers and executives for the life sciences industry with a solid foundation for understanding the essentials as well as the intricacies of Hatch-Waxman and BPCIA litigation and ..read more

By Kurt R. Karst & Michael D. Shumsky — On May 2nd, the U.S. Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review.  That bill is S. 1067, the “Ensuring Timely Access to Generics Act of 2023,” and it would fundamentally transform the playing field for NDA, ANDA, BLA, and aBLA applicants seeking to preserve their rights in the wake of an adverse FDA approval decision. It does so by amending FDC Act § 505(q), the curr ..read more