USA – FDA : Statement on a new effort to improve transparency and predictability for generic drug applicants

The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs. The U.S. already has one of the most effective and efficient generic markets in the world. Generic drugs represented 90% of U.S. prescriptions dispensed in 2017, and the FDA approved or tentatively approved more than 2,000 generic drug applications in 2017 and 2018 alone. But, there is more we may be able to do to facilitate a stable, competitive market.

The agency’s previous efforts to help bolster the competitiveness of the generics market include: taking significant steps to support complex generic drug development and application review; prioritizing the review of certain generics; and publishing a list of off-patent, off-exclusivity brand drugs. Each of these efforts were aimed at getting more competitors into the market, which might drive down prices for consumers – all the while making sure generics meet the FDA’s approval standards and will be manufactured under our rigorous quality standards.

We are working hard to reduce approval times and to enhance the efficiency of certain aspects of the submission process for generic drug applicants. We also are striving to provide the industry with greater transparency in order to provide greater certainty around timing of market entry and empower more informed decisions on how to prioritize their resources.

One area we have identified to help spur investment in generic drug development is the availability of resources that may help applicants predict when their application may be able to receive final approval and when they may begin marketing their product ‒ providing patients timelier access to high-quality, lower-cost medicines. As a result, today we are enhancing one of the agency’s most viewed databases for industry, the Paragraph IV Patent Certifications List, which provides information about exclusivity related to generic challenges of patents on “brand” drug products (180-day exclusivity)…