All eyes on Congress as MDUFA V deal heads to the Hill

Regulatory NewsRegulatory News
| 09 March 2022 | By Ferdous Al-Faruque 

After a significant delay, US lawmakers are poised to review a medical device user fee deal struck between the US Food and Drug Administration (FDA) and the medtech industry this week. The agency says it is still hashing out the details in daily meetings with industry, after which it will make the deal public.

The FDA and medtech industry groups came to an agreement Monday night (RELATED: MDUFA V: We have a deal, Regulatory Focus 8 March 2022).

While the agency initially refused to comment on the matter, it has confirmed that it has reached an agreement in principle on a framework for the Medical Device User Fee Amendment (MDUFA V).

“The framework reflects the commitment by the FDA and the medical device industry to finalizing MDUFA negotiations and prioritizing innovation that will ultimately have positive public health impact,” said FDA spokesperson Lauren-Jei McCarthy. “As the agency completes additional steps required in this process, we are meeting daily with industry to negotiate the details of the commitment letter, with a goal of publishing the draft agreement for public comment in the near future, followed by the public meeting and delivering the final recommendations to Congress.”

On Capitol Hill, lawmakers previously had stated they were disappointed that FDA and industry failed to send them a MDUFA V commitment letter along with commitment letters on the agency’s other user fee programs by the 15 January deadline as required by statute.
Now that a deal has been struck, lawmakers and their staff will be pouring over the details before making any changes, adding any riders and finally voting it into law.

“Congress needs time to thoroughly review each commitment letter and it’s frustrating that it took so long for FDA and industry to transmit the medical device agreement,” a Republican aide on the Senate Health, Energy, Labor and Pensions (HELP) committee told Focus.
The aide also added that it’s essential to Sen. Richard Burr (R-NC) ranking member of the HELP committee, that the user fee agreements hold the FDA accountable to their performance commitments.

“Any agreement that misses that mark will be tough for Sen. Burr to consider seriously,” the aide said. “Sen. Burr is currently reviewing the final prescription drug, generic drug, and the biosimilar drug user fee agreements and looks forward to reviewing the medical device user fee agreement in order to get committee activity underway.”

Despite the delay in getting to a deal and despite the fact that, if enacted, the agreement would double current user fee spending, industry groups are optimistic the deal will help their companies bring new products to market.

“The medtech industry is poised to unleash a whole new dimension of innovation for patients in the coming years,” AdvaMed CEO Scott Whitaker told Focus. “This agreement with FDA will unquestionably help innovators to reach that potential.”

He went on to thank the FDA for its part in coming to an agreement and said he’s looking forward to congressional feedback.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you