F.D.A. Officials, Hoping to Stave Off Critics, Point to Increased Drug Approvals
By GARDINER HARRIS
Published: November 3, 2011

Federal drug officials on Thursday claimed credit for an increase in the approval of new drugs and argued that the results demonstrated the need for legislation to continue financing the current drug approval system.

The Food and Drug Administration approved 35 new drugs in the year that ended in September, a number that was surpassed only once in the past decade.

The agency approved 24 of the drugs before they were approved in any other country. And many of them were important advances, including the first new drug for lupus in 50 years, the first new drug for Hodgkin’s lymphoma in 30 years, and the first drugs for late-stage melanoma that have been shown to prolong survival.

“I want to underscore that we approved a set of drugs that are truly medically important, and in fact did so in a way that made these drugs available to Americans before other places around the world,” Dr. Margaret Hamburg, commissioner of the F.D.A., said at a news conference.

The increase in drug approvals is good news for the pharmaceutical and biotechnology industries, which have failed to produce many new drugs in recent years. New drug approvals peaked in the mid-1990s and have generally declined since then despite increases in research spending. Major drug makers have steadily cut their research spending since 2008 because of poor productivity, although increased spending by the biotechnology industry has generally made up for this shortfall.

For years, F.D.A. officials said little about the declining number of new drug approvals. When some industry analysts blamed government rules for the slowdown, agency officials instead blamed a decline in high-quality industry applications and a general drought in industry labs.

http://www.nytimes.com/2011/11/04/he...e-for-fda.html

Now that approvals are increasing, however, Dr. Hamburg is claiming some credit by saying that the agency has lowered some approval standards — particularly for cancer drugs — and speeded up many of its reviews.

Asked about this apparent contradiction, Dr. Hamburg responded, “I think the point we’re trying to make is that when high quality science, good applications come before us, we are able to act swiftly and surely.”

Part of the reason for the agency’s new message is that it wants to try to defuse growing calls in Congress — supported by biotechnology and medical device industry groups — to weaken its approval processes.

Some conservative economists and commentators have argued recently that Europe is now more supportive of innovation than the United States, pointing to the fact that devices are sometimes approved there earlier. These reports rarely mention that Europe’s health care systems are largely government-run, with prices that are generally significantly lower than those in the United States.

Dr. Hamburg acknowledged that some complex devices are approved first in Europe, but she blamed differing regulatory standards. And she said the device industry did not pay as much in fees to support the F.D.A. as the drug industry did. “A higher percentage of our overall drug program” is supported by fees from drug makers, she said, while the device approval process, with its related fees, “is a younger program and pays for a much smaller share.”

The medical device industry is particularly incensed that the F.D.A. is considering asking for more information about the effectiveness of complex medical devices before approving them.

The proposed changes result from a series of safety scandals involving devices, including metal-on-metal hip implants that underwent very little testing before being approved for sale. The battle between the industries and the agency will intensify in the coming months as Congress considers legislation that includes industry fees crucial to the drug agency.

The legislation is a compendium of deals that the F.D.A. negotiates separately every five years with industry players — the branded drug industry, the generic drug industry, the medical device industry and others. The fees that result from the law now provide a significant portion of the agency’s financing.

Agency officials are worried that the legislation will become enmeshed in next year’s presidential campaign and that Republicans — who have made denunciations of government regulations a central part of their economic message — may look beyond the Environmental Protection Agency and train their fire on the F.D.A., arguably the government’s most important regulatory agency. Twenty-five cents of every dollar spent by consumers is regulated by the F.D.A.

Dr. David Wheadon of the Pharmaceutical Research and Manufacturers of America said the increase in approvals demonstrate a shared commitment to medical progress by the agency and the industry. He said it underscored the need for the fee legislation “to allow F.D.A. to continue to serve, and enhance, its essential function.”

If the legislation with the fees fails to pass next year, the F.D.A. will be forced to fire much of its staff. If the legislation passes but has weakened approval standards, the agency may not need much of its staff.