FDARA Enacted; HP&M Issues Detailed Summary and Analysis

September 7, 2017

On August 18, 2017, President Trump signed into law the Food and Drug Administration Reauthorization Act of 2017 (“FDARA”).  In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDARA also makes several changes to the law concerning medical device manufacturer inspections, and addresses access to generic drugs.  The law significantly changes the FDC Act and the PHS Act in several respects that will have considerable short- and long-term effects on the regulated industry and FDA.

Hyman, Phelps & McNamara, P.C. has prepared a detailed Summary and Analysis of FDARA.  The memorandum summarizes each section of FDARA and analyzes the new law’s potential effects on the FDA-regulated industry.

FDARA includes nine titles, the first five of which concern drug and medical device user fee and pediatric-related programs.  Title VI includes a potpourri of changes to the law styled as improvements related to drugs.  Title VII makes significant changes to the law to enhance FDA’s medical device inspection process.  Title VIII is intended to improve generic drug access and creates a new 180-day exclusivity incentive to encourage the development of so-called “competitive generic therapies.”  Finally, Title IX makes technical and miscellaneous changes to the law.