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Drug Imports Challenge FDA Bill

May 7, 2007 - by Donny Shaw

When the Senate returns today, it will be a quick series of make-it-or-break-it moments for the bill to reauthorize FDA funding.

The bill, which has been reauthorized every five years since its first authorization in 1992, establishes a system that allows the FDA to collect “user fees” from companies that manufacture pharmaceuticals and medical devices in order to fund safety testing and the FDA approval process. These funds are essential to the operation of the FDA, so the bill is considered a “must-pass.”

However, before the Senate left for the weekend, they advanced one step closer to a vote on an amendment that, if approved, would cause the bill to be vetoed by the President. The amendment, which is being offered by Byron Dorgan (D, ND) would allow drug retailers to import and sell less expensive medicines from FDA-approved manufacturers in Australia, Canada, Europe, Japan and New Zealand. The amendment contains provisions that would subject drug exporters to criminal penalties if it was found that they had sent unsafe drugs.

Last Friday, the Senate approved the cloture motion on the bill, a procedure by which the Senate votes to move beyond objections to proceed to a motion, by a vote of 62-28.

Senator Mike Enzi (R, WY), Ranking Member of the Health, Education, Labor and Pensions Committee, and President Bush oppose this amendment because they believe the safety features of the bill will not be effective. In a press release, Enzi argued that the potential savings were not worth the potential risks.

>“We all want affordable drugs. But a counterfeit or tainted drug is unsafe at any
price. The Food and Drug Administration Revitalization Act is about restoring the trust
of the American people in the FDA, where it belongs. Throwing our borders open to
drug importation would instead falsely place that trust in criminals trafficking in illegal
pharmaceuticals.”

If the amendment is approved, there will be another possibility to rescue the bill before it is sent along to be vetoed by the President. Thad Cochran (R, MS) has offered a secondary amendment, an amendment to Dorgan’s amendment, that would require all imported to drugs to be specifically tested and certified by the FDA. The FDA has continually insisted that this kind of testing is beyond their capabilities. Thus, Cochran’s amendment would have the practical effect of killing Dorgan’s amendment. But, in doing so, it could rescue the bill because the President has indicated that he would sign it if both amendments were attached.

It seems a likely path for today’s voting to take. By voting for the Dorgan amendment, Senators can put themselves on record in favor of lowering drug prices for consumers. They will be able to vote for it because they know that the nullifying Cochran amendment will be coming up next. And as an added bonus, Senators get to put themselves on record in favor of drug safety by voting for the Cochran amendment. It’s a win-win for senators and U.S. drug companies.

UPDATE: the Senate voted on the Cochran amendment first, and it passed, 49-40.

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