Drug regulators tout banner year for new medicines ahead of Hill fight on user fees

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The report comes as the FDA, like other federal agencies, faces looming cuts as Congress seeks to pare back a $1.3 trillion deficit. The agency's funding for drug approvals, however, comes from industry user fees, which expire next year.

The agency has reached agreement with the two main drug lobbies — the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO) — on a deal that would trade a $100 million increase in fees over five years for a more predictable drug approval process. A final agreement must be approved by Congress.

Drugmakers have a vested interest in the seamless approval of a new fee structure, and have called on Congress to pass a "clean" renewal of the Prescription Drug User Fee Act that's not bogged down with unrelated ideological riders. The current fee structure expires on Sept. 30, 2012.

"By approving these new medicines, FDA is helping to provide patients with access to new medicines that offer hope in meeting unmet medical needs," David Wheadon, senior vice president for Scientific and Regulatory Affairs at PhRMA, said in a statement. "Of course, the tremendous value of these advances — and FDA’s review and approval of them — underscores the importance of expedient approval of a clean Prescription Drug User Fee Act, which will help provide the resources needed to allow FDA to continue to serve, and enhance, its essential function."

The new report says new drugs approved over the past year include "important advances" for patients, including new treatments for Hepatitis C, a drug for late-stage prostate cancer and the first new drug for lupus in 50 years. It concludes that the U.S. has faster approval times for new drugs than other countries while keeping patients safe, in part thanks to "expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act."


—This report was updated at 12:30 p.m. with comment from PhRMA.