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Drug regulators tout banner year for new medicines ahead of Hill fight on user fees
Federal drug regulators on Thursday touted a banner year for drug approvals as Congress prepares to renew industry user fees that fund the agency.
The Food and Drug Administration released a new report showing that the agency approved 35 new drugs in the fiscal year that ended Sept. 30 — the second highest number in a decade (37 were approved in 2009). The report concludes that 24 of the 35 drugs were approved in the country first, allowing the U.S. to maintain its position as the world leader in new medicines.
"Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients," FDA Commissioner Margaret Hamburg said in a statement announcing the report. "We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century."
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.
