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New antibiotics bill adds 5 yrs protection from generics and fast track FDA review...

Gingrey to introduce antibiotics bill
By Sam Baker - 06/14/11 04:23 PM ET
Rep. Phil Gingrey (R-Ga.) will introduce a bill Wednesday that aims to combat the rise of drug-resistant diseases.

The bill would give drugmakers new incentives to develop treatments for certain pathogens that have become resistant to existing antibiotics. The “Generating Antibiotic Incentives Now” Act, or GAIN Act, drew bipartisan support last year, and Democrats are expected to sign on again when Gingrey reintroduces the measure Wednesday.

Gingrey’s bill targets a handful of drug-resistant pathogens — including the strain of bacteria known as MRSA, which often spreads through hospitals. The bill would give pharmaceutical companies extra incentives to tackle MRSA and other antibiotic-resistant pathogens, and it would give the agency the power to extend those incentives to other treatments.

Qualifying drugs would get a fast-track review from the Food and Drug Administration. The agency would have to decide whether to approve a new product within six months, compared with the standard 10-month window. Once approved, the drugs also would get an extra five years of protection from generic competition.

Drugs that are developed with a companion tool for diagnosing antibiotic-resistant conditions would get another six months of market protection.

http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/166397-gingrey-to-introduce-antibiotics-bill