Legislation fails to establish a national track-and-trace system, but tackles shortages, orphans.
House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support FDA regulatory programs. The bipartisan measure moved through Congress quickly with an eye to avoid getting tangled up in fallout from the imminent Supreme Court decision on health reform, as well as election-year politicking. The FDA Safety and Innovation Act (S. 3187) reauthorizes the Prescription Drug User Fee Act (PDUFA), renews user fees for medical devices and establishes new fees for oversight of generic drugs and for future biosimilar therapies.
FDASIA reflects agreement on the need to spur development of new antibiotics and treatments for rare conditions. It includes a number of provisions sought by FDA to better secure the pharma supply chain, to block import of adulterated products and to detect and prevent drug shortages. However, the legislators failed to agree on a national track-and-trace system for ensuring the integrity of drugs moving through the distribution system. Continued disagreement among wholesalers, manufacturers and pharmacies now opens the way for the states to craft diverse drug pedigree requirements, and to FDA to propose national standards where appropriate.
Several other contentious issues were dropped from the final bill. Generic drug makers lost out on an effort to prevent brand manufacturers from using Risk Evaluation and Mitigation Strategies (REMS) to block access to innovator products needed to test and develop generic versions of drugs and biologics. And pharmacists scuttled a move to stiffen controls on hydrocodone-combination painkillers, proposed as a way to curb rampant abuse of prescription drugs.
The legislation will keep FDA busy with a host of requirements for new guidances, new rules and multiple reports. But more than $6 billion in user fees will roll in over the next five years to keep the agency going.