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Congress approves FDA overhaul

Filed June 5th, 2012 Laurie

Both houses of Congress have approved a plan to completely overhaul the Food and Drug Administration, that has been labeled as inefficient, ineffective, and numerous other derisive terms as the country faces drug shortages and countless dangers from dangerous drugs the agency has allowed to reach the market.

In some ways however, the planned changes at the FDA, nearly unanimously approved by the House and Senate, may actually put people more in danger of untested and potentially dangerous drugs.

According to a report from The Denver Post, the sweeping changes at the FDA would allow some new drugs to reach the market even quicker than some can already. The agency’s 510(k) fast-track approval system allows drugs that could potentially save lives from terminal diseases but haven’t been thoroughly tested to reach their intended users. That same system has allowed some dangerous drugs and medical devices to the market that don’t exactly save lives, but are similar in design or intent to others already approved.

The changes do address the increasing problems posed by ingredients imported from foreign sources that are used to manufacture prescription drugs. The domestic drug supply is stocked with nearly 80 percent imported ingredients but as this share has increased quickly, the FDA has lost sight with the many companies contracted to produce these ingredients. This has led to facilities that have never been inspected by the FDA and dangerous prescription drug ingredients being imported to the U.S., where they eventually reach the public.

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