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Analysis: FDA Reform Bill Hits Senate

Posted on: Tuesday, 1 May 2007, 00:00 CDT

By TODD ZWILLICH

The Senate began debate Monday on a bipartisan bill reforming the Food and Drug Administration's ability to police the U.S. drug supply.

Aides said they expect debate to span most of this week as lawmakers line up a potentially long list of amendments on the bill, parts of which are opposed by drug manufacturers and the Bush Administration.

The core of the bill reauthorizes the Prescription Drug User Fee Act, or PDUFA. The system lets drug makers pay millions of dollars into FDA coffers in exchange for faster drug review times. The bill would increase user fees to nearly $400 million next year, with $30 million for the first time going to improve post-marketing surveillance.

Drug makers support the user fee program and the use of the money for safety monitoring. But the bill also contains other provisions that could run afoul of Republican lawmakers who back the industry in the Senate.

Post-marketing surveillance has become a major issue since the agency was effectively blindsided by increased cardiovascular risks of the pain drug Vioxx in 2004. The drug, which had been sold to millions of U.S. patients, was found to more than double the risk of heart attacks and strokes when used long-term and was subsequently pulled from the market.

The bill gives the agency new power to order drug companies to actively study the safety of drugs after they're on the market as a condition for approval. Now, such studies are negotiated with drug makers and sometimes never fulfilled.

It is absurd that the FDA can identify a public health need and request a study, but can take no action when its request is ignored, said Sen. Edward Kennedy, D-Mass., the chairman of the Committee on Health, Education, Labor, and Pensions, and the bill's main sponsor.

The agency would also get new power to order changes to drug labels. Drug companies would also be required to submit their clinical trial results to a public database, and FDA would have new power to impose a moratorium on direct-to-consumer advertising for new drugs.

On Monday, Sen. Mike Enzi, R-Wyo., the HELP Committee's ranking member defended the new regulatory authority. He said allowing FDA to change labeling and order safety reviews would help prevent a repeat of the Vioxx debacle.

The only option the FDA has now is to pull the drug from the market, disrupting patient care, said Enzi, who is co-sponsoring the bill along with Kennedy.

A Congressional Budget Office report issued Monday concluded the bill would raise taxpayer spending on the FDA by about $550 million over five years. Most of the money would be devoted to pediatric drug research at the National Institutes of Health.

The Consumers Union issued a letter Monday urging the Senate to avoid weakening amendments, saying the current bill would save countless lives.

It also will help return public trust in an agency that has been severely damaged by Vioxx, Paxil and other recent drug safety disasters, the statement said.

Drug makers want the Senate to reauthorize the user fee program without increasing FDA's regulatory clout. In a statement issued Friday, Billy Tauzin, president of the Pharmaceutical Research and Manufacturers of America, urged the Senate to avoid extraneous provisions outside the user feel program.

Significant increases called for in PDUFA funding proposed by the FDA would provide the resources necessary to improve and modernize the agency's already strong drug safety monitoring system, said Tauzin, who chaired the House Energy and Commerce Committee as a one-time Republican Congressman from Louisiana.

Despite Enzi's support, it remains unclear how far other Republicans could go to block the bill or try to weaken it with amendments.

Sen. Charles E. Grassley, R-Iowa, a long-time FDA critic, has said he will also back a measure to create a new, independent Office of Drug Safety within the agency.

But other GOP senators could seek to limit expanding FDA's regulatory role.

Sen. Sherrod Brown, D-Ohio, backed the bill as a viable compromise Monday and urged the Senate to fend off weakening amendments.

It is less stringent than the consumer groups want and more stringent than the drug companies want, said Brown, who was the senior Democrat on the House subcommittee with jurisdiction over FDA before moving to the Senate in January.

Source: United Press International

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