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• W3121982454 abstract "The development of new antibiotics without hav-ing mechanisms to insure their appropriate use is much like supplying your alcoholic patients with a finer bran-dy. (Dennis Maki, IDSA meeting, 1998 [1, 2]) Only one health care bill is likely to pass Con-gress in this election year: the Prescription Drug User Fee Act V (PDUFA V). Every five years, the FDA and the drug and device industries renegotiate the user fees and regulatory priorities for the FDA. PDUFA V is the fifth generation in this process. This bill is very likely to pass Congress this summer because many jobs at the FDA are no longer funded from general federal appropri-ations, but come from these user fees. If the bill doesn’t pass, many people at the FDA will be furloughed or fired. Since it is a “must pass” bill with bipartisan sup-port, PDUFA V has attracted additional provisions, hop-ing to hitch a ride and thus become law. The Generating Antibiotic Incentives Now (GAIN) Act is one prominent example. The GAIN Act is prominently featured in both the House and Senate versions of PDUFA V. The stated objectives of the GAIN Act include increased surveillance of resistant bacteria, more respon-sible use of existing antibiotics, and increased incentives to develop new antibiotics. However, the current draft of the GAIN Act does not provide any binding requirements to implement antimicrobial stewardship, appropriate use, and conservation. It focuses exclusively on bringing new antibiotics to market quickly, without any changes what-soever to patterns of use in either human or animal popu-lations. More brandy for the alcoholics. It didn’t start out this way. The Infectious Dis-eases Society of America (IDSA) testified before Con-gress on March 8, 2012, and asked for both “strong in-centives to spur new anti-infective research and develop-ment (R&D) and promote antimicrobial steward-ship.” [3] While the IDSA’s primary focus has long been on promoting new antimicrobial drugs, this testimony notably included many proposals (advocated by public health organizations such as APUA) for preserving and extending the useful life of existing treatments as well. They suggested creating a new regulatory pathway for “special purpose limited medical use drugs” which would be strictly limited to appropriate antimicrobial use. IDSA called for payors to take a more active role in appropriate use and value-based reimbursement for diagnostics. ID-SA called for implementation of effective antimicrobial stewardship programs as a condition of participation in Medicare and Medicaid. IDSA also specifically recom-" @default.
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• W3121982454 date "2012-01-01" @default.
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• W3121982454 title "All pain, no GAIN: need for prudent antimicrobial use provisions to complement the GAIN Act" @default.
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