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FDA to speed up release
of breakthrough cancer drugs

FDA

March 28, 1996
Web posted at: 6:40 a.m. EST

From Correspondent Jeff Levine

WASHINGTON (CNN) -- CNN has learned that the U.S. Food and Drug Administration is overhauling its approval policy for cancer drugs. Soon, breakthrough treatments will be slated for faster action. The move comes as the agency is under increasing political pressure to change its ways.

The president will unveil the new approach by the FDA at the White House on Friday.

"We finally have the FDA's support, the ability to provide needed drugs to those that are suffering from cancer," White House Chief of Staff Leon Panetta said Thursday.

By declaring that the most promising cancer medicines will move through the FDA faster, the administration hopes to satisfy complaints from some patients and drug companies that the FDA is too slow.

Reform proposals are pending in both the Senate and the House that would impose approval deadlines on the agency or hand over some of its functions to private organizations.

Frist

"It will have provisions that will improve communications and it will have provisions that establish a degree of accountability that either isn't there now or isn't being manifested," said Sen. Bill Frist, R-Tennessee.

While details of the new cancer drug review effort are sketchy, it appears that the FDA will argue that the emphasis on breakthrough drugs could slow down lower priority medications unless the agency gets more money.

Advocates for cancer patients look favorably on the FDA's new direction.

"The FDA could legitimately speed up approval of new drugs as they become available because people are dying and we want to get the drugs available as fast as possible," said Dr. Harmon Eyre of the American Cancer Society.

But agency critics say nothing short of a major overhaul will fix the FDA's deficiencies.

"The problem is, you can't reform the FDA by simply publicly attacking them on certain narrow categories. Because whatever happens, you're gonna get some action where you have a great deal of visibility but other things will slide," said John Calfee with the American Enterprise Institute.

lab tech

Sen. Bill Frist, a physician, says he believes some of the FDA's responsibilities can safely be farmed out.

"It all remains under the umbrella of the FDA in this so-called contracting out. And that is relying on the private sector to provide some resources in the approval of devices and drugs," Frist said.

FDA reform has strong bipartisan support in Congress. So far, the White House hasn't weighed in on the proposals.

The FDA has already shown that it can move quickly; drugs to treat AIDS are the model. Now, the agency's challenge will be to speed other medicines to market, making sure that they are safe and effective.


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