Congress is critical of the Food and Drug Administration for not ensuring the safety of the nation’s food, prescription drug, and medical device supplies.
Congressional leaders have stated, "The health and safety of the American people is at risk… our food supply becomes more dangerous all the time… there is a fundamental breakdown for evaluating the safety of drugs… the FDA is badly broken."
These criticisms occurred after dozens of media stories about FDA warnings on and recalls of food and drugs.
Last year, the Food and Drug Administration Amendments Act of 2007 was signed into law. It:
Reauthorizes user fees on the pharmaceutical industry to fund the FDA drug approval process.
- Makes clinical drug trial results and adverse events public.
- Protects consumers’ rights to hold companies accountable in court if an unsafe drug hurts them.
- Gives the FDA increased authority for the safety of drugs once they’re already on the market, such as requiring companies to add warning labels and conduct post-market safety studies.
- Reduces by 25 percent over five years the number of FDA advisory committee members with drug industry conflicts of interests.
- Opens the internal FDA debate on whether to approve a drug, helping outside researchers see what the FDA’s safety concerns are and where more research is needed.
- Requires the FDA to monitor databases of medical records to find short- and long-term problems with new drugs.
Hopefully the leaders of the FDA, in President George W. Bush’s administration, will enforce this law and improve the situation for American consumers in terms of not allowing ineffective and dangerous drugs to be marketed and removing them from the market.
The Bush FDA –- like the Bush emergency management regulators, product safety regulators, and housing regulators –- has done a poor job in protecting consumer safety and promoting consumer interests.
What’s Congress up to this year in terms of prescription drug reform?
Not much is being debated. It looks like any major reforms will have to wait until after the 2008 elections, according to CitizenJoe, a Web site dedicated to informing the public about national governmental issues.
Last year, Congress worked on these health care initiatives, and lawmakers are following up this year:
- Electronic medical records. Convert health care records to computerized databases.
- Helpful treatments. Set up an independent office that would track the effectiveness of treatments and offer recommendations — incentives or requirements — for the medical profession.
- Cheaper drugs. Require the administration to negotiate reductions in Medicare drug prices.
- Canadian drug imports. Lift the restrictions on importing lower-cost prescription drugs from Canada.
- Generic drugs. Prevent drug companies from paying generic companies not to sell their drugs.
Tomorrow’s Survive and Thrive Boomer Guide will cover What Boomer Consumers Need to Know About Prescription Drugs: How to File Reports About Adverse Reactions.
