Posted by Michael Wonder on 18 Jun 2019
Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
18 June 2019 - The U.S. FDA 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; prioritising the review of certain generics; and publishing a list of off-patent, off-exclusivity brand drugs.
