PhRMA Criticizes FDA’s Proposed Rule on Antibiotic Approvals

Due to the growing problem of antibiotic resistance, physicians have been clamoring for new drug companies to ratchet up antibiotic research and development. Congress had the same concern when it passed the FDA Modernization Act in 1997, which included a provision to revamp the antibiotic approval process. The FDA just issued a proposed rule implementing the provision, which was criticized by the Pharmaceutical Researchers and Manufacturers of America (PhRMA), the drug industry trade association. The proposed rule would allow the FDA to extend 3- or 5-year market exclusivity to new chemical “moieties” only. This would prevent pharmaceutical companies from adding some stabilizers, salts, or other ingredients to an old moiety—of which the FDA lists about 130—and calling the resulting drug a new “active ingredient” entitled to 3- or 5-year exclusivity.

“This proposal flies in the face of congressional intent,” says Jeff Trewhitt, a PhRMA spokesperson. “Key lawmakers made it clear that new antibiotics derived from old ones should be eligible for market exclusivity.”