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Regulatory Costs Slow Development of Lifesaving Antibiotics



(p. A13) In the 1980s, 29 new antibiotics were approved; another 23 were approved during the 1990s. But only nine new drugs made it to market from 2000-10, and a study by the Pew Charitable Trusts shows few drugs in development for the most serious microbial threats such as multidrug resistant Acinetobacter and Pseudomonas aeruginosa.


. . .


To revitalize the search for lifesaving antibiotics, the Food and Drug Administration needs a new way to approve them. Legislation proposed in both the House and the Senate would create a new regulatory pathway that would enable the FDA to approve drugs specifically for patients whose serious infections can't be treated with existing drugs, and for whom there are few or no other treatment options.

For these patients, the FDA would be empowered to approve new drugs based on fewer or smaller clinical studies than for antibiotics intended for broader use. The goal is to reduce the cost of development and accelerate the availability of new drugs for a targeted public health need.



For the full commentary, see:

JONATHAN LEFF And ALLAN COUKELL. "How to End the Regulatory Slowdown for New Antibiotics; With the threat from lethal drug-resistant bacteria growing, the FDA needs to speed up its approval process." The Wall Street Journal (Fri., July 3, 2015): A13.

(Note: ellipsis added.)

(Note: the online version of the commentary has the date July 2, 2015.)






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