All eyes on Senate after House passes user fee reauthorization bill

Regulatory NewsRegulatory News | 09 June 2022 |  By 


The US House overwhelmingly passed its Food and Drug Administration (FDA) user fee reauthorization bill that has been delayed largely due to the COVID-19 pandemic. Now the ball is with the US Senate, which is expected to hold a postponed markup hearing next week on its version of the bill that includes several different provisions.
Unsurprisingly, the House voted 392-28 to approve the user fee reauthorization on 8 June after it had already been approved unanimously by the House Energy and Commerce (E&C) committee last month. (RELATED: User fee reauthorization bill advances in the House, Senate eyes different riders, Regulatory Focus 18 May 2022)
Committee Chair Frank Pallone (D-NJ) issued a statement after the votes were in praising the bill for not just helping fund FDA, but also for provisions that are intended to aid in medical product development, bring generics to market sooner and promote clinical trial diversity. He also noted that the bill is intended to address the current infant baby formula shortage and help FDA’s food safety center hire more staff.
“[It] also includes long-sought reforms to the accelerated approval program that will protect patients and provide FDA with the authority it needs to ensure approved drugs provide a clinical benefit,” said Pallone. “Additionally, the bill will help foster the development of cutting-edge continuous manufacturing technology by allowing FDA to partner with universities across the country to designate them as National Centers of Excellence in Continuous Pharmaceutical Manufacturing.”
Ranking Member Brett Guthrie (R-KY) also issued a statement praising the bill’s passage, arguing it will require less taxpayer spending and save close to $600 million by promoting access to more generic drugs. He also touted it as a step toward making the US more attractive for medical product developers.
“The bill before us today also includes legislation that Chair Pallone and I have been championing for several years to help facilitate the transformation of drug manufacturing processes, so they are more efficient, less costly, and result in improved drug quality,” said Guthrie. “The use of continuous manufacturing technology will not only serve as an incentive for US drug manufacturers to bring their production back to American soil but will also help to reduce drug shortages.”
Jacqueline Berman, a partner at the law firm Morgan Lewis, who specializes in drugs and biologics, told Focus she’s not surprised the bill passed with overwhelming bipartisan support because a lot of the negotiations were hashed out long before it got to the House floor.
What she found particularly interesting is that the bill focuses a lot on drug development with provisions such as those focusing on clinical trial diversity, decentralized clinical trials, real-world evidence, pediatric drug development, and provisions to encourage new ways to develop and manufacture drugs.
“A lot of these things are things that FDA has been talking about for a long time,” Berman said. “So, it's really Congress picking up on those things that it's trying to do.”
Berman noted that the Senate version of the bill does not address drug development in all the ways the House bill does. Most importantly for her, neither bill addresses the issue of rare disease product development or cases where there are unmet needs, which is an area she is particularly focused on.
“What the House bill does do is require that there be various studies that report to Congress regarding the approval of rare disease products, and the kind of information and data goes into those approvals, including the patient voice and the physician perspective,” said Berman. “And this may be setting the stage for more things to come in the future as far as legislative development.”
She said that it’s hard to tell where the issue may pick up from there, but that the 21st Century Cures 2.0 bill that is being discussed may be a vehicle for future legislation that helps promote rare disease drug development. (RELATED: Long-awaited Cures 2.0 bill unveiled, Regulatory Focus 16 November 2021)
Another area worth noting, according to Berman, is what will happen to FDA’s drug accelerated approval pathway. The agency recently came under fire for approving the Alzheimer’s disease drug Aduhelm (aducanumab) despite a panel of its external experts recommending against the approval and questions about the drug’s efficacy. Both reauthorization bills include language on what regulators should take into consideration when approving products through the pathway and steps to take after the approval.
“The House and Senate bills are fairly aligned, requiring the conditions for post-approval studies to be specified at the time of the approval and providing the FDA added authority to require post-approval to have already started at the time of approval, and specifying the process in the statue for expedited withdrawal of an approval if post-approval studies are not conducted or if they don't show a clinical benefit,” Berman noted.
“One interesting thing is that the Senate bill goes a little bit farther than the House bill right now,” she added. “It provides more teeth to the FDA’s enforcement authority by making the failure to conduct required post-approval studies for accelerated approval products a misbranding violation.” (RELATED: Expert proposes changes to accelerated approval reforms in user fee bills, Regulatory Focus 8 June 2022)
The Senate Health, Education, Labor and Pensions (HELP) committee was supposed to hold a meeting on 8 June to markup to its version of the user fee reauthorization bill. That meeting was postponed to 14 June, according to Hill staffers and other sources, because lawmakers needed more time to get their proposed riders added to it.
A medtech industry source with knowledge of how negotiations are taking place on the Hill told Focus they feel more confident than they did a few weeks ago about the Senate and House members reconciling their bills in conference. Though they noted that there is not a lot of time between now and 30 September to pass a bill in the Senate and reconcile it with the House version, considering how many days are left in the legislative schedule.
One area to watch is how the Verifying Accurate Leading-edge IVCT Development (VALID) act is negotiated during conference. The legislation has been an ask from FDA for a long time and is included in the Senate bill and would give the agency additional powers to regulate in vitro diagnostics, including laboratory developed tests, but was not included in the House bill. (RELATED: New diagnostics authorities, accelerated approval council featured in Senate user fee bill, Regulatory Focus 31 May 2022)
The source said it could be used by House lawmakers as a bargaining chip during negotiations, though they are fairly certain the measure has wide bipartisan support.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you