FDA Too Slow In Approving New Drugs, Say Cancer Doctors

By Christine Hall | July 7, 2008 | 8:20 PM EDT

(CNSNews.com) - It is still taking too long to get lifesaving drugs and medical devices to sick Americans, say cancer doctors in a new poll.

Almost two-thirds (61 percent) of the 160 oncologists participating in the nationwide poll said the Food and Drug Administration (FDA) is too slow in approving new medical drugs and devices. Almost eight out of ten said at least on one occasion in their careers, the FDA's approval process has hurt their ability to give patients the best possible care.

When asked if FDA regulations helped or prevented them from using promising new drugs or medical devices to treat patients, opinion was divided: 43 percent said it helped, and 44 percent said the agency prevent them from using the new products.

Overall, doctors give the FDA higher marks than they did five years ago. Nearly half of the oncologists said the agency has gotten better on specific issues related to the approval of drugs and medical devices.

According to the FDA, new drug approval times were "dramatically" reduced, from a median of 22 months in 1992 to a median of less than 12 months in 1999. But the agency admitted the drug approval process increased to more 15 months in the year 2000.

The poll, sponsored by the Washington, D.C.-based Competitive Enterprise Institute (CEI), prompted Sen. Bill Frist (R-Tenn.) to call for further reforms to the law that establishes the FDA's drug approval process. The Prescription Drug User Fee Act is scheduled for congressional reauthorization this year.

"The FDA has made tremendous progress toward streamlining its review and approval process without compromising drug safety," thanks to 1997 reforms passed by Congress, said Frist. "Yet, as many respondents indicated, more needs to be done to further improve the drug review process."

CEI had some specific recommendations for further reforms. The group wants the FDA's veto power over new drugs and devices removed, said Sam Kazman, CEI general counsel. Under Kazman's proposal, the FDA would offer advice to physicians and the public concerning a drug's safety and efficacy, as was the agency's role at its inception in 1906. But it would no longer be up to the FDA to control access.

Ironically, the "world is made safer by dangerous drugs," said Kazman, because riskier drugs can hold potential for cures not possible with drugs already on the market. Moreover, to insist on absolute knowledge of a drug's effects before it goes on the market would effectively translate to no new drugs on the market, he added.

A study by another group, also released on Tuesday, drew the opposite conclusion.

"Given the frequent introduction of drugs for which new serious adverse events are discovered, the FDA should consider raising its threshold for approving new drugs when safe, effective therapies already exist," conclude the authors of a new study published in the Journal of the American Medical Association (JAMA).

"Only half of newly discovered serious adverse drug reactions are detected and documented ... within seven years after drug approval," the researchers state.

They also report that serious adverse drug reactions often emerge after FDA approval. Those reactions are believed to be a leading cause of death in the United States, according to authors Karen E. Lasser, M.D., of Harvard Medical School and colleagues.

Drug approval time is measured from the time the documents are first submitted to the
FDA to the date the drug is approved. It includes any time it takes a pharmaceutical sponsor to address deficiencies found by the agency, along with additional agency review time.

The FDA has argued that approval time for new drugs could be delayed further if Congress does not increase the agency's budget. The FDA's drug approval budget is now over $300 million, half of which is generated by drug application fees paid by pharmaceutical companies.

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