FDA slammed over generics

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FDA Commissioner Margaret Hamburg's return from India is not quite smoothing things over in the US. The regulatory agency is coming under criticism over its handling—or, according to critics, its lack of handling—of the generic drugs which are distributed in the US.

Preston Mason of Brigham and Women's Hospital told a panel that included White House, State Department and FDA representatives that his research indicates generic heart drugs are not working as indicated, Bloomberg reports. Among his findings: a test of 36 copies of Pfizer's statin Lipitor from 15 countries “at best didn't work, and at worst may have had adverse effects on the body,” he told the panel, as reported by Bloomberg.

The agency launched a $20-million generics testing initiative last fall, and Hamburg said one outcome of her 10-day visit to India was that the FDA was going to teach manufacturers how to make compliant medications. India is a major supplier of US generics, but not the only one. Bloomberg reports that critics said the testing initiative, and efforts like Hamburg's promised training, are not enough. A Ranbaxy whistleblower told the gathering “we need more eyes on this in Congress.”

The FDA has barred four Ranbaxy sites from exporting materials to the US, and the country temporarily shut down operations at two plants prior to receiving feedback from a site inspection by India's regulatory authority.

PharmaExec notes, however, that the complaints over FDA generics oversight are not just about offshore manufacturing, and the magazine gives voice to criticism that the Generic Drug User Act has created a wall between drugmakers and the FDA.

The Generic Pharmaceutical Association's CEO Craig Wheeler told the publication that what was once an easy back-and-forth between the office of Generic Drugs and manufacturers is more strained and less expedient, because the FDA now communicates only through Complete Response Letters. “If an [OGD] chemist had a question during the application review process, the agency would call us up and ask for an answer,” Wheeler told PharmaExec. He says manufacturers now have to wait, CRL by CRL, to get anywhere.

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