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Pro-Consumer Drug Safety Reforms Agreed to in Final FDA Bill; Should End Drug Industry Gaming of Safety System

House overwhelming approves bill, CU says major victory for patients

WASHINGTON, Sept. 19 /PRNewswire-USNewswire/ -- Nearly three years to the day Vioxx was removed from the market, Congress has completed a major drug safety reform bill that will give FDA the power to hold pharmaceutical companies accountable for safety problems, and help ensure the industry can't keep drug risks hidden from the public, Consumers Union said.

"Congress is about to give the President legislation that should end the secrecy and foot-dragging when it comes to letting consumers know about unsafe medicines," said Jim Guest, president of Consumers Union, publisher of Consumer Reports. "These reforms have been anxiously awaited by the millions of consumers who take a prescription drug every day and wonder if they know the truth about its side effects."

"Unfortunately, too many Americans suffered or lost their lives because they weren't given the straight story about safety risks by either the drug manufacturer or the FDA," Guest added. "It's now up to the FDA to enforce this law and make sure we get the straight story on the benefits and risks of drugs on the market."

A compromise was reached today by the Senate and House to reconcile differences between the two drug safety bills (S 1082 and HR 2900) passed earlier this year. The reforms are part of an underlying bill reauthorizing user fees on the pharmaceutical industry to fund the FDA drug approval process. The House approved the bill 405-7 today, with a Senate vote expected later this week. A final bill would then go to the President.

Two vital pro-consumer measures survived the closed-door negotiations - making important clinical drug trial results and adverse events public, and protecting a consumer's right to hold companies accountable in court if they're hurt by an unsafe drug.

The clinical trial language will require companies make public a technical summary of their trial results on the Internet within a year or so. This data will be vital for researchers and physicians because it will include information about how a drug performed in those it was tested on, as well as side effects. More consumer-friendly 'lay' summaries of drug trials may be made available in three years if the FDA can develop rules to help ensure they aren't promotional or misleading.

"One of the biggest consumer victories in this legislation is that it will be harder for drug companies to fudge or hide the results of their clinical trials," said Bill Vaughan, senior policy analyst. "Volunteers serve as human guinea pigs in these drug studies, so the results must be made public so researchers, doctors and the volunteers can know if these drugs are truly helpful or harmful."

Another provision in the Senate bill that would have made it more difficult for patients harmed by an unsafe drug to sue the company in state court was removed.

"Given the FDA and drug industry's sometimes sluggish and deceptive track record of protecting the public, it's vital that a patient be allowed to hold a company accountable in court if they are harmed by unsafe medication," Vaughan said.

The legislation includes:

-- Nearly $400 million over the next five years in increased industry

user fees to help pay for improved drug safety monitoring, and it

more effectively includes consumers in future user fee negotiations.

It also gives the FDA increased authority for the safety of drugs

once they are already on the market, such as requiring companies to

add warning labels and conduct post-market safety studies.

-- The FDA could make companies submit their television drug ads for

review prior to running them if there are safety concerns, and

includes heavier fines for running misleading ads. Consumers

also should notice one important change in drug advertisements --

all print ads will include a toll-free number and Web site address

for reporting side effects to the FDA, with a study to determine if TV

ads also should contain the info.

-- Reducing by 25 percent over five years the number of FDA advisory

committee members with drug industry conflicts of interest. Currently,

FDA panels that recommend drugs for market often include several

members with financial ties to the companies whose drug is up for

approval, and the FDA routinely waives the conflicts. CU supported a

ban on all waivers, but the limits are a step toward a better

advisory process.

"This law will make critical, life-saving improvements in drug safety in the years to come, though the public may not see many immediate changes," Vaughan said.

Two key changes will immeasurably improve drug safety in the future, Vaughan added. A Senate-inspired provision opens up the internal FDA debate on whether or not to approve a drug, helping outside researchers see where the FDA's safety concerns lie and where more research is needed. "It will help develop a climate of openness and scientific debate within the FDA," Vaughan said.

The other key change will require FDA to monitor massive databases of medical records to detect short and long-term problems with new drugs. This research will also contribute to research on the comparative effectiveness of different medical procedures. "In the long run, this new medical data monitoring program may be the bill's most important contribution to safer and more effective medicines," Vaughan added.

The bill also includes some important first steps on food safety reforms. It authorizes FDA to enhance seafood inspection, urges it to work more closely with states on food safety, and requires certain parties to report incidents where food might be adulterated. It also requires FDA to establish standards for pet food, a response to the deadly pet food ingredients imported from China last spring. CU urges Congress to continue to work with FDA to expand inspections of seafood and other food imports in the coming months.

Consumers Union, which for three years has advocated for reform of drug safety laws through its "Prescription for Change" campaign, congratulated all the members who worked on the bill, as well as the many consumers who turned their suffering from a harmful drug side effect into action and lobbied Washington for change.

"This legislation shows how Congress can and should be working, and the impact real people can have on reforming consumer protection laws," Guest added.

Guest cited Senators Kennedy and Enzi for shepherding the new law through the Senate, and in the House, Reps. Dingell, Health Chairman Pallone and Reps. Waxman, Markey and Stupak for their "excellent work on the legislation."

SOURCE Consumers Union
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