U.S. PIRG Consumer Blog: FDA bill to House floor

Updated with our release (same day). Over at GoozNews, Merrill Goozner of the Center for Science in the Public Interest explains that the drug safety bill passed by the House Energy and Commerce Committee "slightly improves the ability of the agency to ensure new drugs are safe and well-monitored once on the market." The bill took some amendment hits. We'll post an update next week from U.S. PIRG's health care advocate Paul Brown detailing which of our priorities made it through the committee's amendment gauntlet. In general, we did get $225 million for post-market drug safety efforts, greater transparency in clinical trials, higher civil penalties and stronger conflict of interest rules for FDA advisory committees. We're disappointed that a number of commitee members supported an amendment that passed, severely weakening the bill's direct-to-consumer ad reforms. Here's more on PIRG's drug safety efforts. Below the jump is our pre-vote early Thursday news release.

For Immediate Release For More Information:
Thursday, June 21, 2007 Paul Brown (202) 546-9707

Energy and Commerce Committee to Consider Drug Safety Bills

U.S. PIRG Urges Congress To Allocate More Money for Drug Safety

(Washington, DC)-The Energy and Commerce Committee is considering legislation today that will protect consumers from unsafe prescription drugs. The safety bills are part of a package of nine Food and Drug Administration-related bills. Earlier this week the Subcommittee on Health passed the bills on a voice vote.

The FDA has faced severe criticism over the last few years for approving several drugs such as the pain reliever Vioxx and antidepressant Paxil that were later shown to cause dangerous side effects and deaths. Most recently, the FDA has been chastised for withholding information about the diabetes drug Avandia that links it to increased risks of heart attacks.

U.S. PIRG urged the Energy and Commerce Commmittee to require the FDA to make the results of drug studies available on-line to researchers, doctors and patients.

"An on-line database will allow doctors and patients to weigh the risks as well as the benefits of taking a drug," said U.S. PIRG Consumer Health Care Advocate Paul Brown. "For too long this potentially life-saving information has been hidden from public view."

U.S. PIRG also urged the House Committee, like its Senate counterpart, to allocate an additional $225 million from drug industry user fees for
post-market drug safety reviews, and to include strong conflict-of-interest rules for scientists who serve on FDA advisory panels.

U.S. PIRG also urged the House to give the FDA the authority to issue hefty fines of up to $100 million for drug makers who fail to complete follow-up safety studies.

"The fines are a necessary incentive to get the industry to do the follow up safety studies," Brown said. "Drug makers have failed to complete 70 percent of these studies."

The Energy and Commerce bills are expected to pass with bipartisan support since they are part of must-pass prescription drug user fee legislation that provides nearly $400 million of the Food and Drug Administration's $1.5 billion budget.

The bills are scheduled to go to the House floor in early July. The Senate already passed a similar legislation by a 93 to 1 vote in May.

"The FDA's system for reviewing the safety of drugs has been broken for a number of years and it has cost consumers their health and their lives," Brown said. "Congress must solve the agency's safety problems."

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U.S. PIRG is the federation of state Public Interest Research Groups. State PIRGs are non-profit, non-partisan public interest advocacy organizations.