FDASIA Enacted; HP&M Issues Detailed Summary and Analysis

July 11, 2012

Earlier this week, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (“FDASIA”) (usually pronounced “fuh-day-zha”).  In addition to reauthorizing and amending several drug and medical device provisions that were scheduled to sunset, FDASIA establishes new user fee statutes for generic drugs and biosimilars.  FDASIA also equips FDA with tools intended to expedite the development and review of innovative new medicines that address certain unmet medical needs, and with new authority concerning drug shortages, among other things.  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.

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

FDASIA includes 11 titles, the first 5 of which concern drug and medical device user fee and pediatric-related programs.  Title VI includes myriad changes to the law styled as medical device regulatory improvements.  Title VII makes significant changes to enhance FDA’s inspection authority and the drug supply chain.  Title VIII creates incentives to encourage the development of products for antibiotic-resistant infections.  Title IX expands the scope of products that qualify for accelerated approval and creates a new “breakthrough therapy” program, among other things.  Title X is intended to legislatively address the current drug shortage crisis.  Finally, Title XI reauthorizes certain provisions created by the FDA Amendments Act of 2007, provides for the regulation of medical gases, and includes several miscellaneous provisions, such as provisions on prescription drug abuse, 180-day generic drug marketing exclusivity, citizen petitions, controlled substances, and nanotechnology to name a few.