FDA Says It Is No Slowpoke Approving New Drugs

November 04, 2011

November 4, 2011 — Criticized by manufacturers and congressional Republicans for regulatory slowness, the US Food and Drug Administration (FDA) announced yesterday that it has been pretty quick lately in approving new drugs — 35 in the fiscal year ending September 31, to be exact.

For 24 of those 35 drugs, the United States beat all other countries to the punch in giving them market clearance, the agency said.

The number of new-drug approvals in fiscal 2011 was the second highest in the past decade. The top year was 2009, when 37 drugs received market clearance.

The FDA credits its speedy performance to expedited approval processes, flexibility in clinical-trial requirements, and money collected from manufacturers through the 19-year-old Prescription Drug User Fee Act (PDUFA), which helps fund the drug-vetting process.

"Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a news release. "As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy."

The agency touts many of the drugs in the class of 2011 as important advances in patient care. Stand-outs include:

  • Brentuximab vedotin (Adcetris, Seattle Genetics), the first new drug for Hodgkin's disease since 1977;

  • Belimumab (Benlysta, GlaxoSmithKline and Human Genome Sciences), the first new drug for lupus in 50 years;

  • Boceprevir (Victrelis, Merck) and teleprevir (Incivek, Vertex Pharmaceuticals), both treatments for hepatitis C virus infection;

  • Crizotinib (Xalkori, Pfizer) for late-stage lung cancer and vemuranfenib (Zelboraf, Plexxikon/Roche) for late-stage or unresected melanoma, both of which come with a genetic test that identifies which patients will benefit the most from the drugs.

FDA Announcement Comes at Politically Charged Time

The FDA has been under fire in recent months from congressional Republicans who say that the agency exemplifies how government regulation strangles innovation and impedes economic growth.

With the support of industry, the GOP has proposed a number of measures to streamline and speed up the approval process for drugs and medical devices, such as easing conflict-of-interest rules that are said to discourage experts from serving on FDA advisory panels. That reform has attracted bipartisan backing. Last month, Sen. Amy Klobuchar (D-MN) and Sen. Michael Bennet (D-CO) joined Sen. Richard Burr (R-NC) in introducing a bill that would make FDA conflict-of-interest rules similar in strictness to those for the rest of the federal government.

Congress is embroiled in deciding how much money to appropriate for the FDA in fiscal year 2012, which began October 1. The Democrat-controlled Senate has voted to slightly increase the agency's budget, while the GOP-controlled House seeks a 12% cut.

Lawmakers face another big decision next year when PDUFA comes up for another 5-year renewal. The FDA has proposed a 6% increase in fees collected from pharmaceutical companies. A similar law called the Medical Device User Fee and Modernization Act (MDUFMA) also must be reauthorized in 2012.

Together, PDUFA and MDUFMA generate roughly one third of the FDA's budget, so getting both laws renewed is critical for the agency, lest it is forced to drastically reduce its operations and staffing. However, winning passage of these acts by a politically polarized Congress during an election year could prove challenging.


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