Drugs may be OK’d faster – Fri, 25 May 2012 PST

May 25, 2012 in Nation/World Senate approves overhaul in FDA approvalprocess

From Wire Reports

An outline of the Senate bills key provisions. A14

WASHINGTON The Senate overwhelmingly approved legislation Thursday that would allow Americans speedier access to generic drugs as well as breakthrough treatments for life-threatening diseases as part of a Food and Drug Administration revamping that now heads to theHouse.

The FDA bill includes routine financial provisions as well as new policies that supporters say could save lives by bringing new drugs and medical devices to the marketplace morequickly.

The legislation would allow the continued collection of fees agreed to by brand-name drug and medical device manufacturers in addition to launching new fees on generic drug makers to fund FDA review and approval of productapplications.

At the same time, the legislation would allow the FDA to create a breakthrough designation to speed the development of drugs that may demonstrate substantial improvement over existing therapies for those with serious or life-threateningillness.

The Senate bill, approved by a 96-1 vote, also addresses a number of concerns about the safety and quality of importedmedicines.

The legislation represents a major shift in how the government oversees the pharmaceutical industry. For more than 70 years, the Food and Drug Administration has focused its inspections on U.S. factories. But over time, most companies have moved their operations overseas to take advantage of cheaper labor and materials. Between 2001 and 2008 the number of U.S. drugs made outside of the country doubled, according to FDA figures. Today roughly 80 percent of the ingredients used in U.S. medicines are madeoverseas.

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Drugs may be OK’d faster - Fri, 25 May 2012 PST