WIKIMEDIA COMMONS, UNITED STATES CONGRESS
On Monday (July 9) President Barack Obama signed the US Food and Drug Administration Safety and Innovation Act (S. 3187) into law, reauthorizing user fees that the FDA charges pharmaceutical and device manufacturers as they gain approval for their products.
The law also establishes a new user fee program—raised as part of Obama's newly-legitimized health care legislation—that will require companies making generic versions of protein-based drugs, or biologics, called biosimilars, to pay upon approval of their generic products. The newly signed law also makes several changes to FDA policy meant to speed the approval process for drugs and devices, enacts changes aimed to increase the safety of the drug supply chain, and incentivizes the development of new antibiotics.
Kathleen Sebelius, Secretary of Health and Human ...
