Gottlieb replies 'Yes, maybe' to IOM advice

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The FDA's Scott Gottlieb offered a conditional endorsement of the recommendations of the Institutes of Medicine report and vowed that the agency will communicate better by “approaching the social sciences in the same kind of way that we have approached the hard sciences.”

In a speech to the Manhattan Institute think tank in New York, Gottlieb, who is Deputy Commissioner for Medical and Scientific Affairs at FDA, said many of the IOM's recommendations dovetail with efforts already under way at the agency, but cautioned: “I don't necessarily think improved drug safety is simply a matter of extending new legal authorities to FDA that serve only to add additional burdens to the development process.” Some of the ideas under discussion for improving drug safety, he said, “will do little to make our drugs safe, but will do a whole lot to limit access to needed medicines and slow down the development of innovations.”

Gottlieb outlined areas where he said the FDA must work to improve drug safety: getting better information; refining the agency's analytical tools and approaches for evaluating information; and better communicating findings to the medical community, payers and the public.

Gottlieb said collaboration with payers and other third parties could provide a boost to post-market information gathering, and said the agency was working with CMS on how to cull information from Medicare Part D claims data. The agency, he said, needs further resources to conduct post-market safety monitoring—resources he hopes can be provided through the upcoming PDUFA reauthorization. The agency is overhauling its Med Watch portal and Adverse Event Reporting System to better obtain and evaluate post-market data, he said.

The FDA is making an effort to talk more about unsettled science, he added, and guidances are forthcoming on the communication of drug safety information and vetting drug names to ensure they are not confusing.

Gottlieb also called on the medical community to stop grousing and step up to the plate—or face “the growing attraction by some to the concept of risk management plans.”

“If the profession does not take a more active role in addressing issues of risk associated with the growing benefits but also increasing complexity of the medical products we use, then I worry that there may be a growing desire by some to see the federal government intrude on these decisions, and that could have troubling consequences for patients”—for example, by pushing complicated primary care drugs into the hands of specialists, said Gottlieb.

“I think it does little good when doctors who edit science publications, like the editor of the journal Science, or the doctors who run the leading medical journals pass their time throwing brickbats at FDA from the sidelines. If they really care about our drug safety system, and they want to make it better, then there is a lot doctors-editors can do by getting more directly involved.”


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