Friday, September 21, 2007

FDA drug safety bill passes

Prompted in part by a recent string of drug safety scandals, the Senate approved legislation unanimously to give the U.S. Food and Drug Administration new power to police serious side effects from prescription drugs already on the market, after the measure was approved 405-7 in the House of Representatives. President Bush is expected to sign it into law.

So what does it do? The legislation "allows the FDA to require new warnings on approved prescription drugs, order the completion of post-approval safety studies or limit a product's distribution because of side effect concerns. Companies that do not comply could be fined up to $10 million." And for the first time, "drug and device makers must post basic results for clinical trials of approved products in a public database. The bill also includes an FDA and industry agreement for companies to pay fees to fund agency reviews of television commercials that are submitted voluntarily."

Hopefully, this legislation will help improve the inspection system that's been around since the time Theodore Roosevelt pushed for the Pure Food and Drug Act in response to Upton Sinclair's The Jungle (unfortunately the corporate greed at the root of the problem has not gone away since that time either). All of us who depend on to make sure our food and drugs are safe deserve nothing less from our government.

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