Our Opinion: Concerns about FDA procedures, leader


The U.S. Food and Drug Administration is in need of reform. Dr. Robert Califf, the proposed new leader of the agency, may not be an ideal choice to accomplish it.

U.S. Senator Edward Markey, D-Massachusetts, has placed a "hold" on the nomination of Dr. Califf, a procedural move that will at least temporarily delay a confirmation vote. The senator's concerns relate to strategies addressing opioid addiction, a major issue in Vermont and Massachusetts.

Senator Markey wants the FDA to reverse its decision of last year allowing the pediatric use of the addictive painkiller Oxycontin. The FDA did so without first convening an expert panel to study the issue and offer advice, as it used to do routinely on major public health issues. The senator also wants the FDA to agree to convene such advisory panels before making any rulings on opioids or issues related to drug addiction.

The FDA stopped convening the advisory panels in 2013, Senator Markey told The Boston Globe, after deciding to approve use of another painkilling opioid, Zohydro, in spite of warnings raised about the drug by an expert panel. This indicates that at best the FDA doesn't want to hear any dissenting opinions and at worse the agency is so tight with the pharmaceutical industry it doesn't want to deny Big Pharma approval of any profitable new drugs.

At a November Senate committee hearing, Elizabeth Warren, Massachusetts' other Senate Democrat, and Vermont independent and Democratic presidential candidate Bernie Sanders, expressed misgivings about Dr. Califf's close ties to Big Pharma. which has hired him as a consultant and contributed funding to a research institute he operated. At the hearing, Dr. Califf couldn't come up with any solid answers to Senator Sanders' questions about why drug prices are so much higher in the US than in Canada.

Should Dr. Califf get his appointment, it must come with changes by the FDA. It must be more open about its process and return to convening advisory panels when appropriate.


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