Potential FDA Head Could Change Drug Approval Process Dramatically

Big Think, December 17, 2016. President elect Donald Trump has had several controversial cabinet picks so far for his administration. But in the medical community many are especially concerned over the possible tapping of Jim O’Neill for head of the FDA. While one of the FDA’s main jobs is approving medications, O’Neill said in a speech in 2014 that medications should be evaluated for safety only, what he called “progressive approval.” President of the National Center for Health Research, Diana Zuckerman, told The Hill that such a move would toss insurance companies into limbo. Being unable to rest on FDA approval when deciding coverage, such a move would, throw the entire U.S. healthcare system into turmoil.”

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Congress Just Quietly Handed Drug Companies a Dangerous Victory

New Republic, December 14, 2016. Christmas came early for the pharmaceutical industry this year. Last week, the Senate followed the House in passing the 21st Century Cures Act. Though this bill has been lauded by liberals for providing much-needed funds for medical research, its real impact will be elsewhere. Whereas drug approval traditionally required the demonstration of real clinical benefit in a randomized clinical trial, under the Act drug firms will increasingly be able to rely on flimsier forms of evidence for approval of their therapies (incremental steps in this direction, it is worth noting, have already occurred). The Act, by reconfiguring the drug regulatory process, lowers the standards for drug approval—a blessing for drug makers, but an ill omen for public health.

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Congress Passes Sweeping Health Care Bill

U.S. News & World Report, December 7, 2016. We opposed the 21st Century Cures bill. It passed anyway. Drug and device companies are popping the champagne. Republicans bought off the White House by promising research $$ for pet projects. How will the law affect you?

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