PHARMACY

Senate OKs $375 million for FDA

BY Drew Buono

WASHINGTON In an effort to fix the problems at the Food and Drug Administration regarding inspections and the safety of drugs being imported into the country, the Senate passed a budget resolution on Friday to give the agency an additional $375 million, a 20 percent increase over this year, according to The New York Times.

One number showed that, while there are 566 plants in China—where the recent heparin scare occurred—that export drugs to the U.S., only 13 of them were inspected by the FDA last year.

The agency does not have the money to inspect many more, and the Bush administration has no plans to fix this problem. The administration’s budget calls for a 3 percent increase in allocated funds next year, not enough to keep up with rising costs.

“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the FDA,” said Sen. Edward Kennedy, D-Mass., who pushed for the new financing.

But the money is not assured, as President Bush has threatened to veto appropriations that go beyond his requests.

With this uncertainty, many in Congress have considered using a user-fee system to pay for foreign inspections. “Why should the taxpayer pay for these inspections so that you can close a plant here and open it over there to ship it back?” Sen. Bart Stupak, D-Mich. said. “It will be sustainable income so that we don’t have to get into these budget battles every year.”

But even this idea has received criticisms from other groups, such as Public Citizens. It argues that it would be a “terrible idea” because it would lead the agency to become lax with those who pay their salaries.

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FDA to review ulcer gel, HIV medications

BY Drew Buono

WASHINGTON The Food and Drug Administration is conducting two safety reviews of the drugs Regranex gel, used for leg and foot ulcers and the HIV medications Ziagen and Videx.

Diabetic patients using Johnson & Johnson’s Regranex face an increased risk of cancer from using the gel.

Data analyses from another study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking GlaxoSmithKline’s Ziagen or Bristol-Myers Squibb’s Videx as part of their drug therapy.

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FDA OKs Dendreon’s phase III Provenge trial

BY Drew Buono

SEATTLE The Food and Drug Administration has agreed to allow Dendreon to get the final results from its phase III trial for its prostate cancer drug Provenge.

Last May, the FDA requested additional clinical data from Dendreon to support its effectiveness claim for Provenge despite a vote by the Cellular, Tissues and Gene Therapies Advisory Committee in favor of approving the drug. The committee voted 13 to 4 that the product was effective and 17 to 0 that it was safe.

That request led three congressmen: Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, to point accusations that conflicts of interest on the advisory committee might have led some of its members to send written requests to the FDA asking that the drug not be approved. One of the members of the committee is a lead investigator for a competing cancer drug made by Novacea.

According to the company, interim results from the IMPACT study of Provenge still are expected later this year, but final results are now expected in the second half of next year rather than the second half of 2010.

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