User fee reauthorization bill advances in the House, Senate eyes different riders

Regulatory NewsRegulatory News | 18 May 2022 |  By 

The House Energy and Commerce committee voted unanimously to send legislation to reauthorize the US Food and Drug Administration’s (FDA) user fee programs to the floor in a 55-0 vote. The bill has significantly different riders from one proposed in the Senate because of severe time constraints, according to an industry source with extensive legislative Hill experience.
On 18 May, the Energy and Commerce committee voted to move forward with the much-anticipated Food and Drug Amendments of 2022 bill that would renew FDA’s user fee programs before they expire in September. The bill has seen significant delays, in part blamed on lack of resources to help negotiate new deals between FDA and the pharmaceutical and medical device industries due to the COVID-19 pandemic.
It was passed by the committee to be picked up for a final vote on the House floor a day after its sister bill was proposed in the Senate Health, Energy, Labor and Pensions (HELP) committee. While some riders in the two bills overlap, a significant number of them don’t. For instance, the House bill does not include the Verifying Accurate Leading-edge IVCT Development Act (VALID Act) that would give FDA additional powers to regulate in vitro diagnostics (IVDs), including laboratory developed tests (LDTs).
Regulating LDTs has been a hot topic for years as FDA has argued to lawmakers it needs additional oversight authority as such tests have become more complex, are intended for riskier uses and are in some cases technically being mass manufactured. At the end of the Obama administration, the agency even set up a framework to start regulating LDTs but that came to a halt under the Trump administration, and then FDA Commissioner Scott Gottlieb said the agency needed new legislative authorities to move forward.
During the markup hearing, Rep. Diana DeGette (D-CO), noted that the committee did not include the VALID act in its package but expects the final bill agreed upon by the House and Senate to include it regardless.
The bill, originally introduced by Sens. Michael Bennett (D-CO) and Richard Burr (R-NC) last summer, would create a new framework for FDA to regulate diagnostic tests. DeGette said she was pleased that HELP Committee Chair Patty Murray (D-WA) and Ranking Member Burr were able to hash out a bipartisan VALID Act deal to be included in the Senate user fee reauthorization package.
“We thought about doing this as an amendment to [the House] bill but we would prefer to work with our staff and with you [E&C Chair Rep. Frank Pallone (D-NJ)] as this VALID Act moves through the Senate process to make sure that as we move forward that we put this important regulation of diagnostic testing into the bill,” said DeGette.
A medical industry source and veteran Hill staffer said they weren’t surprised by the fact that the House bill and proposed Senate bill have significant differences between them.
“There just was not enough time to work across the aisle,” they told Regulatory Focus. “They just ran out of time.”
The source noted the HELP committee won’t markup their version of the user fee reauthorization bill until June.
The source noted that Hill insiders have always known the VALID act was going to come out of the Senate rather than the House because of how the committees divvied up legislative priorities.
There are a number of other issues that have strong bipartisan support in the House and the Senate, that will likely be a part of one bill but not the other such as support for giving FDA authority to allow predetermined change protocol plans for certain software as a medical device (SaMD) products, reforms to how Certificate to Foreign Government (CFG) are given, and defining what constitutes medical device remanufacturing.
The industry source says there’s a strong chance the Senate and House will eventually come to an agreement on the bills during reconciliation. But that if that doesn’t come to pass, there’s a chance that the House may have to adopt whatever version of the bill the Senate passes, especially if there’s pushback from certain lawmakers.
There won’t be a lot of time to merge the two bills together after the Senate passes its version but it’s definitely the more likely scenario due to the fact the provisions in the bills have wide bipartisan support, according to the industry source.
“The other path is the House majority may have to walk back some of its wants,” the source said. “[In that scenario] the House passes something and the Senate passes something but because of time, the House may have to adopt the Senate measures.”
The reason the source says the second pathway is even in consideration is because the party caucuses are not monolithic, and within each caucus there are specific sub-political agendas which means their respective Whips have their work cut out for them.
“Watch the dynamics between Murray and Burr, and also Murray and Pallone,” the source said. They said if Rep. Pallone signals to Sen. Murray they are on board with the Senate riders, then the reconciliation process will go a lot smoother. However, if Pallone shows signs of not backing certain provisions in the Senate bill supported by Murray, then there might be a problem.
So far, the source noted that Burr and Murray have been in lockstep with each other which may be a good sign the Senate version of the bill will be easier to pass, according to the source.
During the E&C markup, there seemed to be a lot of agreement and support between lawmakers on what the provisions entail and how they can advance health care.
E&C Ranking Member Cathy McMorris Rodgers (R-OR) said the House package was patient-focused and pro-innovation. She argued that the provisions in the bill would advance novel-drug manufacturing technology, address shortfalls in FDA drug inspections, facilitate the use of decentralized clinical trials and create incentives for domestic manufacturing.
“The FDA Act may be a timely opportunity to demonstrate our commitment to meaningfully address failures of our federal scientific agencies and their program integrities and oversight responsibilities,” she said. “Trust needs to be rebuilt in public health and my hope is in reauthorizing these user fee programs will be a step in that direction.”
Several provisions were added to the bill to increase diversity of participants in clinical studies.
A major issue identified during the pandemic is the fact there is insufficient medical data on minorities and women, and it’s become a top priority for the Biden administration to encourage better medical research for underrepresented populations.
Rep. Robin Kelly (D-IL) noted that she co-authored the Diverse and Equitable Participation in Clinical Trials Act (DEPICT Act).
“These provisions will require FDA [product] applicants to establish specific enrollment targets based on race, ethnicity, age and sex, and to develop diversity action plans,” she noted. “This will ensure that diverse populations are represented in clinical trial research so that these communities can trust that new innovative therapies are safe and effective.”
Similarly, Rep. Raul Ruis (D-CA) talked about the importance of diverse representation in clinical trial and included the Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act (DIVERSE Trials Act) that would allow trial participants to participate remotely.
He noted that often minority patients do not have the ability to physically go to physician offices for periodic check-ups during trials. His bill would also require FDA to produce further guidance on decentralized clinical trials and give sponsors the ability to pay for ancillary costs such as transportation, lodging and meals.
The legislative measures proposed in the House user fee reauthorization bill line up with the recommendations made in a National Academies of Sciences, Engineering, and Medicine report on steps stakeholders can take to encourage clinical trial diversity. (RELATED: New report urges more clinical trial diversity, recommends incentives, Regulatory Focus 18 May 2022)
Though not included in the bill, Rep. Tom O’Halleran (D-AZ) noted that he was working on legislation that would give FDA regulatory authority to allow predetermined change control plans for certain software as a medical device (SaMD) products.
“As medical device have become more advanced I believe that this will be important to the future of streamlining FDA resources and ensure that devices are as safe and effective as possible,” he said.
Other proposed provisions in the bill include requiring FDA to produce guidance on what factors should be considered when the agency reviews proposed changes to a third-party vendor implementing existing risk evaluation mitigation strategy (REMS) for a particular drug.
The provision was from Rep. John Joyce (R-PA) who said it was important in addressing issues that arise when manufacturers switch vendors. He said in the past there have been problems with patient data not transferring properly, creating a myriad of problems for doctors and patients.


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