Thursday, Sept. 27, 2007
(Washington, D.C.) – President Bush’s expected signing today of landmark prescription drug safety legislation will help ensure that patients, doctors and consumers know more quickly about potentially dangerous medications – and hold the drug industry’s feet to the fire when it comes to keeping drug risks from the public, Consumers Union said.
“This law signals a new era of openness and accountability when it comes to prescription drug safety,” said Jim Guest, president of Consumers Union, publisher of Consumer Reports. “The Food and Drug Administration will begin to have the tools and resources to protect the public from unsafe medications. And the drug industry has been put on notice that it no longer can keep vital safety information from consumers.”
President Bush is expected today to sign the Food and Drug Administration Amendments Act of 2007, a bipartisan bill that includes some of the most significant reforms to drug safety laws in 45 years. Back in 1962, lawmakers were responding to the Thalidomide disaster – a morning sickness drug that caused severe birth defects – by passing a law that required a drug be scientifically proven effective before being put on the market.
The latest reforms were prompted in part by the pain medication Vioxx and the antidepressant Paxil. In those cases, the drugmakers did not make fully public their clinical trial studies showing dangerous side effects and continued to heavily market the drugs. The cornerstone of the new CU-backed law will require results from most clinical drug trials be made public on the Internet, so consumers will know both the good and bad news about medications.
“We can’t have a fair, just and safe marketplace if industry keeps vital safety information from the public,” Guest added. “Making clinical drug trial results public is one of the biggest consumer victories in this legislation, because it will more clearly show the benefits, as well as the risks, of a drug.”
The new law also includes:
• Nearly $400 million over the next five years in increased industry user fees to help pay for improved drug safety monitoring. It also gives the FDA increased authority for the safety of drugs once they are on the market, such as requiring companies to add warning labels and conduct post-market safety studies. The FDA can levy heavy fines if industry fails to comply.
• Monitoring massive databases of medical records to detect short and long-term problems with new drugs. This research will also contribute to research about which drugs and medical procedures work best.
• Provisions to encourage more accurate drug advertising. The FDA could make companies submit their television drug ads for review prior to running them if there are safety concerns, and the law 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. The provision was suggested by consumer activist Kim Witczak of Minneapolis, MN, who lobbied Congress heavily for drug safety reforms after the death of her husband, Woody.
• Limiting industry conflicts of interest. The law reduces by 25 percent over five years the number of FDA advisory committee members with drug industry conflicts of interest. CU supported a ban on all conflicts, but the limits are a first step toward a better advisory process.
• More openness in the internal FDA process. The legislation now makes public internal 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.
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.
Contact: Bill Vaughan, Susan Herold, 202-462-6262