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FDA User Fee Bills Sail

Government: Congress remains on track to finalize legislation by early summer

by Britt E. Erickson
May 31, 2012 | A version of this story appeared in Volume 90, Issue 23

Credit: FDA
FDA user fee bill will enable more testing throughout the pharmaceutical supply chain.
A man in a lab coat and blue gloves pokes an array of white rectangles with a pen-like object. A cord leads from the top of that object to a gray and blue box.
Credit: FDA
FDA user fee bill will enable more testing throughout the pharmaceutical supply chain.

Both the Senate and House of Representatives have overwhelmingly passed legislation that reauthorizes FDA to collect user fees from industry to help accelerate the review of new drugs and medical devices. The Senate passed its version of the bill (S. 3187) on May 24, and the House passed its version (H.R. 5651) on May 30.

Industry-paid user fees fund about 60% of FDA’s drug review budget and 20% of its device center budget. Both the drug and medical device user fee programs are set to expire on Sept. 30, the end of the fiscal year for the federal government. If Congress is unable to finalize a reauthorization bill before then, FDA will have to lay off about 2,000 employees and its drug and device review processes will grind to a halt.

The legislation passed by both the Senate and House reauthorizes FDA’s drug and medical device user fee programs for five years, beginning in fiscal 2013. Both bills also authorize new user fee programs for generic drugs and biosimilars, the generic equivalents of biologic drugs.

Lawmakers were careful not to add controversial amendments to the bills to keep them moving swiftly. They did, however, include some regulatory reform measures related to drug safety and drug shortages. Both bills also permanently reauthorize two programs aimed at increasing studies on pediatric drugs.

The legislation “will keep patients safer by modernizing the FDA’s inspection process for foreign manufacturing facilities, while also improving access to new and innovative medicines and devices,” Sen. Tom Harkin (D-Iowa), chairman of the Senate Health, Education, Labor & Pensions Committee, and Sen. Michael B. Enzi (R-Wyo.), ranking Republican on the committee, say in a joint statement. “It will also reduce drug costs for consumers by speeding the approval of lower-cost generic drugs and help prevent and address drug shortages,” the senators say.

The Senate replaced an earlier version (S. 2516) of its bill with S. 3187 on May 15, adding a new section on establishing a national system for tracking pharmaceuticals throughout the supply chain. The language was spearheaded by Sens. Michael F. Bennet (D-Colo.) and Richard M. Burr (R-N.C.). Lawmakers in both chambers are still working out the final details for that system.

The proposed tracking system has the support of industry groups, including the Pharmaceutical Distribution Security Alliance, whose membership spans the U.S. pharmaceutical distribution system. The Generic Pharmaceutical Association, which represents generic drug companies, is urging Congress to quickly complete its work on the system so that it can be included in the final bill.

Leaders in the Senate and House are expected to resolve other relatively minor differences between the bills in a conference committee, with a goal of getting a final bill to President Barack Obama by July 4.



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