American Journal of Public Health, December 16, 2016. The Obama Administration has been a strong voice for many public health issues, including tobacco control, childhood obesity, and reproductive health. The Affordable Care Act is also a major accomplishment. But, under the same administration, the FDA caved into political pressure by approving medical products based on lower standards of scientific evidence. What will happen going forward?
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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.
Read More »Congress Passes Bill with Billions for Cancer Research
December 7, 2016. The 21st Century Cures Act, the most expensive and far-reaching health reform bill since the ACA, has just been passed by Congress.
Read More »Trump’s Rumored FDA Candidate Strikes Nerve
The Hill, December 8, 2016. Against all expert opinion, Jim O’Neill, “a snake oil salesman” with no medical background, is rumored to head the Food and Drug Administration (FDA) in 2017.
Read More »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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