Importation bill mandates FDA inspections

We all knew it was just a matter of time: A bipartisan cadre of senators has introduced legislation that would allow nationwide re-importation of prescription drugs. The "Pharmaceutical Market Access and Drug Safety Act" will reduce drug prices immediately for consumers, the senators said in announcing the bill, and will "ultimately force the pharmaceutical industry to lower drug prices in the United States." According to the Congressional Budget office, the measure could save American consumers $50 billion over 10 years.

That's $50 billion out of drugmakers' top lines--and at a time when pharma is already suffering from generic competition, patent expirations and sparsely populated pipelines. Even though the measure was expected, you can bet there will be plenty of tension headaches in pharma's executive suites today.

Another, less publicized part of the bill would hit overseas drugmakers hardest: Drugs could only be imported from FDA-approved manufacturing plants. As you know, only about one in 13 foreign plants have been inspected by FDA, and the inspections lean heavily toward Europe. India and China, as the fastest-growing but least-inspected drugmakers on the globe, could be hit hard by the legislation if it's passed.

"There will be inspections of every facility and approval by the FDA for every facility ... because we think that is the appropriate approach to take when it comes to this critical legislation," Senator Olympia Snowe told reporters at a press conference. Snowe went on to point out the lack of FDA oversight of foreign plants, despite the huge increase in global outsourcing in pharma, adding that, "FDA should be required to inspect every facility."

- read the senators' press release
- see the story at domain B
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read more at the Economic Times

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