Bringing more drug competition to the market and addressing the high cost of medicines is a top priority of the Administration, the Department of Health and Human Services (HHS), and FDA. In 2017, FDA announced the Drug Competition Action Plan (DCAP) to further encourage robust and timely market competition for generic drugs and help bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program. Through this plan, FDA is helping remove barriers to generic drug development and market entry in an effort to spur competition so that consumers can get access to the medicines they need at affordable prices.
To date, the Agency has focused its efforts under the Drug Competition Action Plan in three key areas:
- improving the efficiency of the generic drug development, review, and approval process;
- maximizing scientific and regulatory clarity with respect to complex generic drugs; and
- closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended…