New bill seeks to bring plants exporting drugs to US under FDA inspection

05 Mar 2009

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A group of US senators from both the ruling Democrat and opposition Republicans today introduced a bill in the Senate that aims to limit drug imports to FDA-approved plants overseas.

The bill, introduced by senators Byron Dorgan (Democrat), John McCain (republican), Debbie Stabenow (democrat) and Olympia Snowe (Republican), on Wednesday, seeks to import prescription drugs from abroad in order to reduce drug costs in the US.

Once the bill is enacted, US-licensed pharmacies and drug wholesalers would be able to import FDA-approved drugs from Canada, Europe, Australia, New Zealand and Japan.

If passed by both Houses of the Congress and signed into law by President Barack Obama, the legislation would hit India and China, which currently account for a major share of medicines supplied to the US, hard.

"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 meet, which was also addressed by Senator John McCain and Senator Byron Dorgan.

The legislation, which has the backing of the White House, is expected to help reduce healthcare costs in the US by about $50 billion, according the Congressional Budget Office estimates.

"We have, you know, had so many medications or ingredients of medications manufactured in foreign plants. And there are very few inspections that take place in those foreign plants. In fact, it could be as much as 20 years in between inspections, if at all. And 40 per cent of ingredients are manufactured in China and in India," Snow said.

Last year, US President Barack Obama, then an Illinois senator had co-sponsored an identical bill seeking FDA approval of plants exporting medicines to the US.

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