The U. S. Food and Drug Administration (FDA) will likely undergo many changes in 2017 during the Trump Administration. Although Dr. Robert M. Califf has expressed a desire to remain as Commissioner, a new Commissioner will likely be appointed. Structurally, the FDA must establish at least one disease-focused intercenter institute in 2017 due to the recent passage of the 21st Century Cures legislation. FDA will continue to define the scope of “real world evidence” and establish acceptable uses to support both pre- and post-market evidentiary burdens. Numerous guidance documents are expected to be finalized—such as updates to novel clinical trial design, clarification on the Clinical Laboratory Improvement Amendments (CLIA) waiver policy, and collection and use of patient experience data in drug development.
2017 also marks the year of all of the User Fee Acts (UFAs) reauthorizations. The UFAs are statutory authorizations for FDA to collect user fees in exchange for establishment of performance measures on review and approval timeframes, which have historically also included numerous “modernizations” of FDA’s regulatory framework. The intense political negotiations between industry and FDA often seen during UFA re-negotiations may be tempered in this 2017 cycle, however, due to the need to implement the new provisions in the 21st Century Cures Act.
Regardless of what 2017 has in store, NYSBA’S Food, Drug, and Cosmetic Law Section will help you prepare during its Annual Meeting on Thursday, January 26 with the following agenda:
• Dan Lear, J.D., Director of Industry Relations, Avvo presenting on the Ethics of Attorney Advertising.
• Drug Law Updates on reverse payment litigation; drug pricing developments, new drug and new chemical entity definitions; and cannabis/canabidiol (CBD)—drug or dietary supplement, featuring Jeremy Unruh, J.D., M.B.A., chief compliance officer, general counsel, PharmaCann.
• Medical Devices updates featuring Suzanne O’Shea, J.D., director, Navigant, on expected guidance documents, the impact of 21st Century Cures Act, and vulnerable policies/guidance under the Trump Administration.
• Hot topics in foods/dietary supplements including how a new ingredient intended for use in dietary supplements can be brought to market, featuring Daniel Fabricant, EC/CEO, Natural Products Association, and Mark Ullman.
• Animal Biologics: the regulation of animal biologics by both the FDA and USDA and how this interrelates to the regulation of human biologics with Clint Vranian, Vitalpet; Hans Draayer, founder and chairman of the board, Edge Veterinary Vaccines Consulting Group; and Dr. Kent McClure, general counsel, Animal Health Institute.
• Recent Enforcement Developments in Organic and Natural Claims for Cosmetics discussing recent enforcement activity including Rebecca L. Griffith, senior attorney, ASRC National Advertising Division program; Deborah A. Marrone, Federal Trade Commission; and Sheila A. Millar.
• Legal Status of Tobacco Products Under the Deeming Rule, featuring Mitch Zeller, director, Center for Tobacco Products/FDA and Dean Cirotta, MBA, president & COO, EAS Consulting Group.
• Legislative update of the pending biosimilars substitution rule in New York.
• Offsite networking reception.