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Bipartisan bill addresses drug shortages, speeds up research

in News
Megan Paulsonby Megan Paulson
June 27, 2012

WASHINGTON D.C. – A bill that passed both Congressional houses nearly unanimously this June would make affordable prescription drugs more accessible and help Montana businesses producing new drugs.

The Food and Drug Administration Safety and Innovation Act includes a provision co-sponsored by Sen. Jon Tester, D-Mont., to encourage development of new drugs that treat rare and highly resistant infectious diseases.

Known as the GAIN Act, the provision streamlines the approval process by extending patents for drug makers and allowing them to work with non-accredited investors.

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Short for ‘Generating antibiotic incentives now,’ it will benefit companies such as the Bozeman-based pharmaceutical company Microbion, which specializes in developing innovative drug treatments, particularly for antibiotic resistant infections.

Its passage will change the playing field in the antibiotic industry, said Microbion President and CEO Dr. Brett Baker. If allowed to work with non-accredited partners, Microbion could access big international companies that “can really move something,” Baker said.

The bill also extends existing agreements between pharmaceutical companies and the FDA to speed up drug approvals and improve the safety of medicine and medical devices.

Because it will allow new drugs into the marketplace faster and reduce the costs of generic drugs, the non-partisan Congressional Budget Office estimates the bill will save taxpayers $360 million over the next decade.

It also encourages government and private companies to work together to quickly develop and approve treatments for chronic illnesses like Alzheimer’s disease.

The bill passed the Senate by a vote of 96-1 earlier this spring, and last week it passed the House unanimously.

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