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Would Washington’s FDA Fix Cure the Patients or the Drug Industry?

Posted on October 20, 2015

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(HealthNewsDigest.com) – The 21st Century Cures Act, legislation that would speed up approval for medications and medical devices, has garnered an unusually broad range of support — offering a rare example of how major initiatives can get traction even in today’s gridlocked Washington, ProPublica’s Alec MacGillis writes.

But bipartisan consensus does not necessarily affirm the bill’s worth. Far from showing that Washington can still get things done, it shows how a lobby can blow past skeptics if the pot of resources is sweet enough. In this case, billions of dollars in new federal medical research funding for the NIH. 

Key takeaways:

  • The bill’s proponents say it would spur innovation, particularly when it comes to finding cures for rare diseases — of the 10,000 or so known diseases, 7,000 are considered rare and treatments exist for only 500. 
  • However, critics argue that the intense lobbying is drowning out some warnings about patient safety, saying the bill “could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”
  • The list of entities lobbying on the bill now runs to about 1,800 quarterly entries in the Senate’s lobbying database, with more than 1,100 lobbyists registered as working on it — staggering even by Washington standards.


More in the full story here: http://www.propublica.org/article/would-washingtons-fda-fix-cure-the-patients-or-the-drug-industry.


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