The House Energy and Commerce committee voted unanimously to send legislation to reauthorize U.S. Food and Drug Administration (FDA) user fee programs upstairs in a vote of 55. -0. The bill has endorsements that are very different from a propose in the Senate due to severe time constraints, according to an industry source with extensive legislative experience Hill.
On May 18, the Energy and Commerce Committee voted to go ahead with the highly anticipated 2022 Food and Drug Amendments bill that would renew the FDA’s user fee programs before they expire in September. The bill has faced significant delays, in part due to lack of resources to help negotiate new agreements between the FDA and the pharmaceutical and medical device industries due to the COVID-19 pandemic.
It passed the committee to be taken up for a final vote in the House a day after its sister bill was proposed to the Senate Committee on Health, Energy, Labor and Pensions (HELP). Although some endorsements of the two bills overlap, a significant number of them do not. For example, the House bill does not include the Verification of the correctness of the law on the development of advanced IVCT (VALID Act) which would give the FDA additional powers to regulate in vitro (IVD), including laboratory-developed tests (LDT).
Regulation of LDTs has been a hot topic for years, as the FDA argued with lawmakers that it needed additional oversight authority, as these tests have become more complex, are intended for riskier uses, and are , in some cases technically mass-produced. At the end of the Obama administration, the agency even put in place a framework to start regulating LDTs, but that stopped under the Trump administration, and then FDA commissioner Scott Gottlieb said that 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 to by the House and Senate include it anyway.
The bill, originally introduced by Sens. Michael Bennett (D-CO) and Richard Burr (R-NC) last summer would create a new framework for the 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 reach a bipartisan VALID Act agreement to be included in the Senate user fee reauthorization package.
“We thought of doing this as an amendment to [the House] invoice 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 ensure that as we move forward, we put this important diagnostic testing regulation into the bill,” DeGette said.
A medical industry source and a former Hill staffer said they weren’t surprised that the House bill and the proposed Senate bill had significant differences between them.
“There just wasn’t enough time to work across the aisle,” they said Regulatory guidance. “They just ran out of time.”
The source noted that the HELP committee will not change its version of the user fee reauthorization bill until June.
The source noted that Hill insiders always knew the VALID Act was going to come out of the Senate rather than the House because of how the committees divided legislative priorities.
There are a number of other issues that have strong bipartisan support in the House and Senate that will likely make it into one bill but not the other, such as support for giving the FDA the power to authorize predetermined change protocol plans for certain software as medical device products (SaMDs), reforms to how the Certificate to Foreign Government (CFG) is issued, and the definition of what constitutes the remanufacturing of medical devices.
The industry source says there is a good chance that the Senate and House will eventually agree on the bills in the reconciliation. But that if that doesn’t happen, the House may have to pass the version of the bill passed by the Senate, especially if there’s a refusal from some lawmakers.
There won’t be much time to merge the two bills after the Senate passes its version, but that’s certainly the most likely scenario due to the fact that the bills’ provisions enjoy a broad bipartisan support, according to the industry source.
“The other way is that the majority of the House may have to back away from some of their wishes,” the source said. “[In that scenario] the House passes something and the Senate passes something, but because of time, the House may have to pass the measures of the Senate.
The reason the source says the second route is even being considered is because party caucuses are not monolithic and within each caucus there are specific sub-political agendas meaning their respective whips have work to be done.
“Look at the dynamic between Murray and Burr, and also Murray and Pallone,” the source said. They said that if Rep. Pallone signaled to Senator Murray that they agreed with the Senate runners, the reconciliation process would go much more smoothly. However, if Pallone shows signs of not supporting certain provisions of the Murray-backed Senate bill, then there could be a problem.
So far, the source noted that Burr and Murray have been in tune with each other, which may be a good sign that the Senate version of the bill will be easier to pass, the source said.
During the E&C markup, there seemed to be a lot of agreement and support among 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 bill’s provisions would advance new drug manufacturing technology, close gaps 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 the failings of our federal science agencies and the integrity of their programs and oversight responsibilities,” she said. “Trust needs to be restored in public health and I hope reauthorizing these user fee programs will be a step in that direction.”
Several provisions have been added to the bill to increase the diversity of participants in clinical studies.
A major problem identified during the pandemic is that there is not enough medical data on minorities and women, and it has become a top priority for the Biden administration to encourage better medical research to underrepresented populations.
Rep. Robin Kelly (D-IL) noted that she co-wrote the Diverse and Equitable Participation in Clinical Trials Act (DEPICT Law).
“These provisions will require the FDA [product] applicants to set specific enrollment goals based on race, ethnicity, age and gender, and develop diversity action plans,” she noted. “This will ensure that diverse populations are represented in clinical trial research so that these communities can have confidence that innovative new therapies are safe and effective.”
Likewise, Representative Raul Ruis (D-CA) spoke about the importance of diverse representation in clinical trials and included the Diversifying Investigations Through Fair Research Studies for All 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 doctor’s offices for periodic check-ups during the trials. His bill would also require the FDA to produce additional guidance on decentralized clinical trials and give sponsors the option to pay for incidental costs such as transportation, lodging and meals.
The proposed legislation in the House User Fee Reauthorization Bill aligns with recommendations made in a report by the National Academies of Sciences, Engineering and Medicine on actions that parties stakeholders can take to encourage diversity in clinical trials. (RELATED: New report calls for greater diversity in clinical trials, recommends incentives, Regulatory guidance May 18, 2022)
Although not included in the bill, Rep. Tom O’Halleran (D-AZ) noted that he was working on legislation that would give the FDA regulatory authority to authorize predetermined change control plans for certain software products as medical devices (SaMD).
“As medical devices have become more advanced, I think this will be important for the future of streamlining FDA resources and ensuring devices are as safe and effective as possible,” he said. .
Other provisions proposed in the bill include requiring FDA to produce guidance on factors to consider when the agency reviews proposed changes to a third-party vendor implementing the risk mitigation strategy. (REMS) existing for a particular drug.
The provision came from Rep. John Joyce (R-PA), who said it was important to address issues that arise when manufacturers switch suppliers. He said that in the past there have been issues with incorrect transfer of patient data, creating a myriad of problems for doctors and patients.
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