Senate approves overhaul in FDA approval process
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 the House.
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 more quickly.
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 product applications.
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-threatening illness.
The Senate bill, approved by a 96-1 vote, also addresses a number of concerns about the safety and quality of imported medicines.
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 made overseas.
The Senate bill would do away with a requirement that the FDA inspect all U.S. factories every two years, and give the agency more discretion to focus on foreign facilities. Currently, the FDA inspects the average foreign manufacturing facility just once every nine years. Under the bill, FDA inspectors would be instructed to target the most problematic manufacturing sites, regardless of location.
In addition, the bill would allow U.S. border agents to turn away drug imports from companies that deny or delay FDA inspectors.
Meanwhile, the Senate voted down several contentious amendments to the bill, including one that would have allowed Americans to import low-cost prescriptions from Canada. Importation has long been favored by seniors groups, including AARP, but opposed by the pharmaceutical industry, which would stand to lose sales. FDA regulators also oppose the idea, saying they cannot guarantee the safety of drugs overseen by Canada.
Senators also rejected an effort by Sen. Richard Durbin, D-Ill., to regulate nutritional supplements.
The fees are a key source of funding for the FDA, and failure to pass a bill before the existing authorization expires in September would result in layoffs. The bill would extend the fee agreements for five years, through fiscal 2017.
Proponents say the new fee on generic drug makers, estimated to bring in $300 million a year, would slash the time it takes to approve new drugs from 30 months to 10.
The House is working on companion bill similar to the Senate legislation. Lawmakers from both chambers will meet this summer to work out differences between the two versions.
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