Drug companies will in future find it harder to bury the results of trials that show their products in a poor light. The US Food and Drug Administration (FDA) Amendments Act, passed by Congress last week, will require clinical trials to be registered and their results placed in a public database.
The new law contains a raft of measures to improve drug safety, including better monitoring for adverse effects after drugs hit the market. The trials registry is vital, says Merrill Goozner of the Center for Science in the Public Interest in Washington DC, because problems such as the heart attack risk posed by the diabetes drug Avandia may only come to light when independent researchers reanalyse the results of multiple clinical trials (see 鈥淕SK discussions over Avandia critic reached highest levels鈥�).
The FDA will also have to give the reasons for its decisions on new drug applications, noting dissenting scientific opinions. 鈥淔or us, this is huge,鈥� says Francesca Grifo of the Union of Concerned 杏吧原创s in Washington DC, which last year revealed that many FDA staff felt their work was subject to political interference.
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But the act fails to impose new restrictions on drug advertising and continues to allow the FDA鈥檚 budget to be part-paid by industry.
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