Legislation Overhauling Approval of Drugs, Devices Coming Next Week

Posted 22 April 2015 | By Alexander Gaffney, RAC 

Legislation Overhauling Approval of Drugs, Devices Coming Next Week

Congressional legislators are preparing to unveil the next iteration of the 21st Century Cures Act, a massive piece of draft legislation intended to overhaul the way in which the US Food and Drug Administration (FDA) regulates and incentivizes the development of new medical products.


The legislation was first unveiled in January 2015 after months of discussions between legislators, regulators, industry, innovators, academics and patients. As extensively explained by Regulatory Focus, the draft provisions of the bill would radically overhaul the way in which many products, including drugs and medical devices, are brought to market.

Read our extensive Regulatory Explainer on the 21st Century Cures Act here.

Some of the most noteworthy provisions call for longer periods of marketing exclusivity for innovative drugs, faster approvals for breakthrough designation drugs, special approvals for antibiotics, transferrable periods of marketing exclusivity, a new breakthrough designation status for medical devices and making it easier to use social media to promote medical products.

Read our recap of some of the 21st Century Cures Act's most noteworthy provisions here.

One thing the draft legislation didn't have when it was unveiled in January 2015 was bipartisan support. Diana DeGette (D-CO), one of the leaders of the House Energy and Commerce Committee's 21st Century Cures Initiative, did not endorse the bill when it was released.

"While I don’t endorse the draft document, I know that with continued engagement, we can reach a bipartisan consensus to help advance biomedical research and cures," she said in a statement at the time.

Other Democrats were similarly wary of the bill, saying it contained some measures they could not support.

Legislation Moving Forward

Now legislators have indicated they will soon move forward with the next iteration of the 21st Century Cures Act in the hopes of having a bill ready to sign by the end of 2015.

In a statement this week, Fred Upton (R-MI), the Republican co-leader of the 21st Century Cures Initiative, said he hopes to have the next draft of the legislation available to the public by the end of April. The hope is to have the bill ready for a vote in the House of Representatives by June 2015, Upton told Michigan Live.

Upton noted Republican and Democratic teams "have spent countless hours negotiating over the last few months on policy language" in the legislation.

Separately this week, the Senate's Health, Education, Labor and Pensions (HELP) Committee said it would soon hold a hearing on "The Future of Medical Innovation for Patients"  featuring some of FDA's top regulators. The committee is pursuing its own medical innovation agenda, and has released a white paper outlining its proposed efforts.  


House Energy and Commerce Committee

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