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Bill to Ease FDA Approval Draws Praise and Rebuke

Posted in News on 12.1.2016

Alosa Health founder Dr. Jerry Avorn was quoted in the Wall Street Journal regarding a healthcare bill scheduled for a vote in the House next week. The bill in question covers a breadth of topics from funding for biomedical research to opioid addiction to the FDA’s regulatory processes.  The proposal to ease FDA standards for approving drugs and medical devices has elicited support from those in industry who say the current approval process is long and arduous, to the detriment of patients waiting on new treatments. It has also drawn sharp criticism from those in the medical and academic communities who say that relying on fewer studies and studies that adhere to less-strict scientific standards to inform decision-making will result in ineffective or unsafe treatments on the market.

This bill throws into the spotlight a broader question about linking up priorities from opposing groups in order to build a broad base of support for legislation. For instance, the same medical and academic institutions that would likely oppose deregulating FDA processes might be swayed by the promise of funding for research and public health initiatives. What some view as bipartisan compromise, others view as a kind of extortion in which accepting money for medical research cedes control of drug and device approvals to industry. See our founder Dr. Jerry Avorn’s take by reading the full article here.

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