FDA reform

A reform that has been too long in coming.


Senate Bill Would Boost FDA Powers - WSJ.com The Senate approved legislation that would change how drugs are regulated in the U.S., giving the Food and Drug Administration new powers to restrict medications that raise serious safety concerns.

The 93-1 vote will give the bill, sponsored by Sen. Edward Kennedy (D., Mass.) and Sen. Michael Enzi (R., Wyo.), strong momentum in eventual negotiations with the House over the measure's final language.

Congress is expected to pass a version of the bill before the fiscal year ends in September because it reauthorizes the user fees the FDA collects from the drug industry and makers of medical devices. Those fees are vital to the agency's operations.

John Dingell (D., Mich.), chairman of the House Energy and Commerce Committee, expressed “dissatisfaction” with the FDA's handling of drug-safety issues and said he favored “structural and resources changes within the agency,” as well as cultural reform. Rep. Henry Waxman (D., Calif.) has introduced a bill that largely mirrors the Senate's approach.

If it becomes law, the Senate bill, called the Food and Drug Administration Revitalization Act, could shift the balance of power between regulators and the pharmaceutical industry. It requires the FDA to monitor drugs after they go on the market and provides new funding for that job. The bill would also require companies to make public the results from many of their studies.

Too much power over public health is in the hands of for-profit Big Pharma, and to be blunt, Big Pharma's lackies in the FDA. And apparently, several Senators too:

In a victory for the drug industry, the Senate rejected an effort to legalize imports of prescription drugs. Some other elements that the industry opposed, such as restrictions on advertising, were toned down.

from the Chicago Tribune:

The Senate on Monday effectively killed a measure that would have let Americans buy prescription medicines from foreign suppliers, which sponsors said could have saved consumers billions of dollars.

By a 49-40 vote, senators approved a provision requiring the government to certify that imports are safe -- a step the Bush administration is unlikely to take. The amendment, offered by Sen. Thad Cochran (R-Miss.), was seen as a major victory for the pharmaceutical industry.

Cochran's caveat “is clearly a poison pill,” said Sen. Bernard Sanders, a Vermont Independent and a strong supporter of allowing imports.

and let us make assumptions as to what industry is a major financial donor to the senators from Illinois:

Sen. Dick Durbin (D-Ill.) voted against the Cochran provision; Sen. Barack Obama (D-Ill.) did not vote.

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This page contains a single entry by Seth A. published on May 10, 2007 8:41 AM.

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