The legislation Bush signed into law on Thursday also requires drug companies to make public the results of clinical trials showing how their drugs performed and authorizes the Food and Drug Administration to fine drug companies to force them to comply.
It will be harder now for drug companies to bury clinical trials that show a new drug's performance in a negative light. Clinical trials will now be registered in a data base.
Having a drug companies clinical trials in a public registry data base is important because problems with a drug may only be apparent when independent researchers have access to the results of multiple clinical trials to reanalyze the results, said Merrill Goozner of the Center for Science in the Public Interest in Washington DC, according to NewScientist.
Goozner said that was how the risk of heart attack for patients taking the diabetes drug Avandia became known.
With millions of people using prescription drugs knowing the risks a new drug might carry with it is critical. Many of those drugs are sometimes rushed to market, after the government has given its approval, without pharmaceutical companies completing follow-up studies on the safety of those drugs.
Safety problems with the popular painkiller Vioxx three years ago led to Congress acting on reforming how the FDA handles the issue of drug safety for drugs that are already on the market, rather than focusing so much on experimental drugs waiting for approval.
The FDA now has broad new powers to ensure the safety of the nation's prescription drugs.
Part of the FDA's cost to review products that need its approval comes from fees that it collects from drug companies and medical device manufacturers. The new law renews the FDA's ability to collect those fees for the next five years. five years programs to collect fees from drug and medical device manufacturers. This money defrays FDA's costs in reviewing products that need its approval.
