Leahy Looks to Amend ‘Cures’ Bill as Senate Prepares for Passage

Posted 06 December 2016 By Zachary Brennan

placeholder+image

Sen. Patrick Leahy (D-VT) on Tuesday proposed an amendment to the 21st Century Cures bill that would make it more difficult for brand name drugmakers to halt or delay generic or biosimilar competition.

The amendment, supported by the Generic Pharmaceutical Association on Tuesday, would promote competition by further encouraging manufacturers to share product samples with generic and biosimilar companies so that more of these lower-cost treatments can be approved by the US Food and Drug Administration (FDA). 

The amendment rehashes a previously introduced bill known as the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.

All Signs Point to Passage

Following the release of President Barack Obama’s weekly address on Saturday urging the Senate to pass the 21st Century Cures bill, and yesterday evening’s 85-13 cloture vote in favor of the bill (after re-naming a section of the bill for Vice President Joe Biden’s son Beau, who died of cancer, and little disagreement or debate), it seems destined for approval (a final Senate vote is expected on Wednesday).

[For more on what the bill will mean for FDA, read our explainer on the legislation here.]

For many, the bill’s approval means more funding for the US opioid epidemic, more funding for research at the National Institutes of Health and FDA, and supposedly faster pharmaceutical and medical device approvals.

However, the faster approvals have been a topic of fierce debate in recent weeks, with academics like Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, and Michael Sinha, a post-doctoral fellow, saying the bill “is still a bad deal for patients,” particularly as the NIH funds have to be re-authorized each year, and as allowing the use of real world evidence and data summaries are likely to lower the bar for FDA approval of new drugs.

Similarly, Sens. Bernie Sanders (D-VT), Elizabeth Warren (D-MA) and Jeff Merkley (D-OR) have taken a public stance against the bill and said it is nothing more than a boon for pharmaceutical companies.

“How can we talk about a bill dealing with the pharmaceutical industry without addressing the elephant in the room: The fact that we pay the most of anyone in the world for drugs,” Sanders said on the Senate floor on Tuesday.

Suchira Ghosh, an FDA attorney at Axinn, told Focus that although the bill allows the use of real world evidence and summaries in some, yet-to-be-defined future cases, nothing in the bill actually lowers the bar for FDA approval, and many of the provisions will be dependent on how FDA interprets and implements the law.

Leahy Amendment

GPhA Letter

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: 21st Century Cures, GPhA, Leahy, generic drugs, NIH

Regulatory Exchange: Latest Updates From the Community