| Rep. Markey has long been in favor of sweeping FDA overhaul, aimed at restoring the public’s faith in the drug approval system. In a FDA reform bill singed into law in 2007, Rep. Markey negotiated provisions to give the FDA the authority to require label changes, order post-market studies to follow up on safety concerns and gather information needed to reassess the risks compared to the benefits of a drug already on the market, as well as establish an online clinical trials registry and a clinical trials results database, both available to the public.
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LegislationFeb. 16, 2007 - H.R.1165 - The SAFE Drug Act -
To amend the Federal Food, Drug, and Cosmetic Act to establish
additional authorities to ensure the safe and effective use of drugs,
to establish whistleblower protections for certain individuals, and for
other purposes.
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