On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA and USPTO have been working together to leverage their combined expertise to promote competition and access to affordable medications in the marketplace.
On the collaboration between the two agencies, he added: “The objective of our two agency’s collaboration under the Executive Order is to ensure the patent system is not used in ways that unjustifiably delay generic drugs and biosimilar competition beyond that reasonably contemplated by law. …While our agency doesn’t play a direct role in drug pricing, we can — by encouraging development of generic and biosimilar products – support increased competition in the health care market. This can have a transformative impact by improving affordability and increasing access to these essential medicines.”
To this end, the Commissioner noted that the FDA has a number of programs to advance the research, development, approval, and marketing of high-quality generics and biosimilars, such as the Science and Research program established under the Generic Drug User Fee Amendments (GDUFA), as well as the regulatory science program pilot under the Biosimilar User Fee Act (BsUFA) that focuses on advancing the development of interchangeable biosimilar products and improving the efficiency of biosimilar product development. Additionally, he noted that the FDA has multiple initiatives, many of which are outlined in the Drug Competition Action Plan (DCAP) and the Biosimilars Action Plan (BAP) — aimed at reducing “gaming” of FDA regulations to unduly extend brand monopolies and unfairly delay market competition.
The Commissioner concluded: “The USPTO and the FDA will continue to collaborate in the development of policies aimed at protecting and promoting U.S. innovation, advancing competition, and lowering prescription drug prices for all Americans. We must achieve the appropriate balance that encourages meaningful innovation in drug development while not unduly delaying competition that provides relief from the high cost of medicines.”