Track And Trace Missing From FDA Reform Act
By Lori Clapper, Editor
Less than a week after the U.S. Senate almost unanimously passed the FDA Safety and Innovation Act, the U.S. House of Representatives passed its nearly identical FDA Reform Act of 2012 (H.R. 5651) in a 387-5 vote on Wednesday, May 30. However, one item did not make it into the House version — a drug traceability plan to protect the pharmaceutical supply chain from counterfeit drugs. The Senate bill leaves room for a national uniform plan for serialization, but Reuters says that element could be cut if lawmakers can’t agree on the details.
The FDA and the pharmaceutical industry have been at odds over track and trace requirements for nearly 10 years. The FDA wants drugmakers to track individual containers of medicine, but big pharma companies like Pfizer and Merck are pushing back based on the cost and complexity of the FDA’s plan, according to a separate Reuters report. A coalition of drugmakers, distributors, and pharmacies have proposed an alternative plan to track larger lots of drugs, and leaves room for more stringent rules down the road.
Besides serialization, the House and Senate must come to terms on other issues, including medical device safety and antibiotic incentives, before agreeing to a final FDA bill. Despite these differences, the final version of the bill will almost certainly empower the agency to require pharmaceutical manufacturers to report any supply disruptions to avoid shortages, as well as re-authorize the FDA’s user fee programs.
User fees, paid by brand-name and generic drugmakers and medical device manufacturers, are expected to supply nearly half of the FDA’s $4.5 billion budget next year, and will enable the FDA to significantly speed its evaluation and approval processes for medical products, ensure safety of imported drugs, and help bring critical drugs to market more quickly. User fees are renewed every five years, and the current version is due to expire this September.
Lawmakers hope to iron out the final FDA bill by July 4.