21st Century Cures Act Dismantles Meaningful Federal Regulation of Drugs and Devices

The 21st Century Cures Act was passed (unanimously) out of Committee on July 7, 2015 and passed by the House on July 10, by a vote of 344 to 77.  

It could have been called the Stealth Act:  There was very little preceding discussion of this bill, despite its potentially huge effects on US healthcare.  TV’s Katie Couric, having been affected by cancer, “wrote” a piece in the HuffPo about the bill’s importance, published one day before the vote.  Forbes opined against the bill, discussing Jerry Avorn’s piece in the NEJM.  That was about the extent of discussion in the media.

Jerry Avorn, a Harvard med school professor and drug industry critic, noted for example:

An underlying premise of the bill is the need to accelerate approval for new products, but this process is already quite efficient. A third of new drugs are currently approved on the basis of a single pivotal trial; the median size for all pivotal trials is just 760 patients. More than two thirds of new drugs are approved on the basis of studies lasting 6 months or less… 

More problematic proposals include encouraging the use of “shorter or smaller clinical trials” for devices and the request that the FDA develop criteria for relying on “evidence from clinical experience,” including “observational studies, registries, and therapeutic use” instead of randomized, controlled trials for approving new uses for existing drugs…

The bill would also encourage the FDA to rely more on biomarkers and other surrogate measures rather than actual clinical end points in assessing the efficacy of both drugs and devices. The FDA already uses surrogate end points in about half of new drug approvals…

Another section would allow device makers to pay a third-party organization to determine whether the manufacturer can be relied on to assess the safety and effectiveness of changes it makes to its devices, in place of submitting an application to the FDA. Thus certified by the external company, a device maker would be authorized to continue to assess its own products on an ongoing basis… 

The effects of this bill would force untested and unregulated drugs and medical devices on the public.  It would dismantle much of pharmaceutical regulatory science and practice in the US. 

This bill’s provisions exemplify ‘regulatory capture’ on steroids.

This single bill–just one law approved by 82% of our federal House members– would dismantle in one step patient protections that have been established over a century, established in response to medical disasters that killed thousands of Americans, and which are accepted worldwide.

Perhaps we should be grateful that the corruption in Washington has become so naked, and so bold.

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