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Bill would fast-track promising antibiotics for FDA approval

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The antibiotics arena hasn't proved lucrative enough for Big Pharma, leading to a mass exodus from the field in recent years. But pharma companies may have a reason to get back in the antibiotics game.

A group of bipartisan members in the House of Representatives introduced a bill late Thursday that aims to combat the growing threat of so-called "superbugs" by essentially providing a fast-track route to FDA approval for promising new antibiotics and antifungals. The bill would allow the FDA to approve antibiotics needed for life-threatening infections based on data from smaller clinical trials--an incentive that could save companies money on drug development.

The bill, called the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013, also proposes a plan to strengthen antibiotics resistance monitoring by the Centers for Disease Control and Prevention and make this data publicly available to healthcare providers, hospitals and academics.

"The proposed limited population antibacterial and antifungal drug pathway would speed patient access to important antibacterial and antifungal drugs to treat serious or life-threatening infections where there exists an unmet medical need by allowing them to be approved based upon smaller, more rapid clinical trials. It is often not feasible for these drugs to be developed using traditional, large clinical trials due to the limited numbers of patients in whom these infections currently occur," wrote Barbara Murray, president of the Infectious Disease Society of America, in a Dec. 12 letter to the bills' sponsors, Reps. Gene Green (D-TX) and Phil Gingrey (R-GA), shared with FierceBiotech.

The legislation comes just after an FDA announcement earlier this week laying out the agency's plan to phase out the use of antimicrobials in food. The FDA will work with animal pharmaceutical companies to revise the FDA-approved use conditions on the labels of these products. The biggest limitation of the plan, though, is that it's voluntary.

The bill builds on the Generating Antibiotic Incentives Now (GAIN) Act, enacted by Congress last year, which provides drugmakers with an additional 5 years of exclusivity for qualifying new antibiotics under the Food and Drug Administration Safety and Innovation Act (FDASIA).

A September CDC report estimated that over 2 million people in the U.S. are sickened every year by antibiotics-resistant infections and approximately 23,000 die. Most of these infections--including E. coli, salmonella, Shigella and C. difficile--are acquired in healthcare settings, such as hospitals or nursing homes.

- read the bill text (PDF)
- see the press release

Related Articles:
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Report: Antibiotics pipeline lackluster as resistance surges
FDA blamed for stymying new antibiotics

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