Showing posts with label Cures Act. Show all posts
Showing posts with label Cures Act. Show all posts

Sunday, December 18, 2016

The FDA Should Approve Drugs Based on Evidence, Not Emotions. But a New Law and Trump Spell Trouble.

On Dec. 7, the New York Times ran an inspiring, dangerous story about Celine Ryan, a 50-year-old whose advanced colon cancer was successfully treated with experimental immunotherapy. Inspiring, because researchers repeatedly rejected Ryan’s requests to participate in a clinical trial, but her heroic refusal to accept their verdict led to her eventual admission—and remission. Dangerous, because although the article emphasizes that success in one patient proves very little, Ryan’s story served as powerful anecdotal reinforcement of a widespread and mistaken view that groundbreaking cures are stuck in trial stages, and that patients need to take it upon themselves to fight bureaucratic gatekeepers for access. This type of narrative undermines the necessity of the Food and Drug Administration, whose scientific standards are crucial to keeping medical costs down, preventing health crises, and ensuring objective evaluations of new drugs....
http://www.slate.com/articles/health_and_science/medical_examiner/2016/12/the_21st_century_cares_act_could_be_dangerous_for_everyone.html


Friday, December 16, 2016

Monday, December 5, 2016

STAT: Republicans reach deal to pass Cures Act by end of year, but Democrats pushing for changes

House and Senate leaders announced late Friday night that they had finally hammered out a deal on landmark legislation designed to speed federal approval of new drugs and devices and boost funding of medical research. But what Republican lawmakers call the "final" version of the 21st Century Cures Act is actually still in negotiation with Senate Democrats, a Senate health committee senior aide told STAT on Sunday. ...
https://www.statnews.com/2016/11/27/cures-act-deal/?s_campaign=stat%3Arss









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