A Very Brief Primer on the FDASIA

On July 9, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law by President Obama.  Thanks to the FDA Law Blog for the correct pronunciation of the acronym–“fuh-day-zha.”  This law focuses on several goals.

Under FDASIA, the FDA can collect “user fees” in order “to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also reauthorizes two programs that encourage pediatric drug development.”  Other provisions of the FDASIA aim to improve pharmaceutical supply chains, change approval and regulation processes, and provide incentives for the development of drugs to treat rare diseases.

Part of the effort to combat drug shortages includes provisions requiring manufacturers to notify the government of any problems or issues that may lead to shortages down the line; in the past, such reports were completely voluntary by the manufacturer.  Manufacturers who fail to report under the law are subject to sanctions.  More about the FDASIA’s provisions with regard to drug shortages can be found here.

Other sections of the law incentivize manufacturers to research and develop products for antibiotic-resistant infections, expedite the approval process for certain products, and regulate “medical gases.”

If you’re up for some light reading, the FDA Law Blog provides a link to a 75-page “summary” of all 11 titles of the law by the FDA powerhouse firm Hyman, Phelps & McNamara, which can also be found here.  Or, if you think that a summary just isn’t enough to satisfy your curiosity, you can read the law itself here.