Congress prepares to markup pandemic legislation, all but confirming FDA-related provisions won’t advance

Quick background: the Pandemic and All-Hazards Preparedness Act

• The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004 (see a Congressional Research Service report on its legislative history here).
• Under the original PAHPA, Congress reauthorized several emergency response and preparedness programs together in a single passage, and also established new authorities to support emergency preparedness and response – including establishing the Biomedical Advanced Research and Development Authority (BARDA) and clarifying terms such as “qualified countermeasures” under Project BioShield.
• PAHPA has been reauthorized several times since its original passage, including as the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) and the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (PAHPAIA). Each of these re-authorizations, along with provisions in other, related legislative packages such as the 21^st Century Cures Act, sought to add to, tweak and/or amend the U.S. public health emergency preparedness and response infrastructure.
• For example, while the FDA’s Emergency Use Authorization (EUA) authority was added to the Federal Food, Drug and Cosmetics (FD&C) Act under Project BioShield in 2004, PAHPRA in 2013 disconnected the EUA declaration from the Public Health Emergency (PHE) declaration, instead allowing HHS to determine independently that circumstances exist justifying Emergency Use separately from the PHE context.
• PAHPA must be reauthorized by the end of federal fiscal year 2023, or by September 30, 2023. Congress is already working on the reauthorization process. In June, the House Committee on Energy and Commerce (E&C) held a hearing on the House’s initial proposal, featuring testimony from witnesses and some legislative proposals for discussion. This included 21 individual pieces of legislation, including both the actual PAHPA reauthorization text and 20 potential policy riders that could be attached to the must-pass reauthorization. The Senate is also working on its own version of a PAHPA reauthorization package, with leadership from the Senate Health, Education, Labor and Pensions (HELP) releasing a proposed version for discussion in early July. As AgencyIQ discussed at the time, that draft included only limited FDA-related provisions, primarily one measure from HELP Ranking Member Bill Cassidy that would effectively double the priority review vouchers available to sponsors that receive approval for a medical countermeasure – in effect, one that must be kept and one that can be sold.

E&C’s health subcommittee will discuss PAHPA reauthorization at a “markup” session

• The July 13 markup: Unlike the June hearing, at which House members discussed (but did not vote on) legislation, the July hearing will focus on legislative business. At a markup, Representatives can offer amendments to – or vote to advance – specific bills.
• There are 17 bills on the calendar, including the PAHPA reauthorization. The House version of the PAHPA reauthorization package now clocks in at 33 pages long, and includes a few (but not all) of the proposals from the June hearing, including a focus on the Strategic National Stockpile (SNS), enhancing state, local and regional emergency preparedness and bolstering the health system workforce. Interestingly, while the House bill would re-use the “PAHPRA” acronym from the 2013 version of the reauthorization, the short title of this bill is “Preparing for All Hazards and Pathogens Reauthorization Act” (emphasis added). In the 2013 version, the second “P” stood for “Preparedness.”
• The House PAHPRA reauthorization package does include some interesting provisions. This includes a proposal to add an Advisory Committee component to the Public Health Emergency Countermeasures Enterprise (PHEMCE). Further, the HHS Assistant Secretary for Preparedness and Response (ASPR) would be directed to establish a “diagnostic testing preparedness plan” that would sketch out a plan for “rapid development, authorization, scaling, and procurement, and distribution of diagnostics and clinical and diagnostic laboratory testing capacity” during a Public Health Emergency (PHE). Another component of House PAHPRA (which we also saw in June) is a measure to authorize a program to support research and development on “emerging” viral pathogens or those with “pandemic potential,” including platform technology research and “flexible medical countermeasures against priority respiratory virus families” or pathogens. A new provision in the PAHPRA text would direct the Government Accountability Office (GAO) to review HHS work and capacity on the rapid production of qualified countermeasures during a PHE and make recommendations to Congress on gaps.
• In addition to PAHPRA, the markup includes 16 other bills. While these legislative proposals are all health-focused, not all are related to life sciences regulatory policy, such as policies related to Medicaid and graduate medical education. There are several proposals related to the operations of the Centers for Disease Prevention and Control (CDC), including one called the Preparedness and Response Reauthorization Act that would focus on enhancing CDC’s epidemiological capacity and reauthorize its existing response programs. Another bill, the Support for Patients and Communities Reauthorization Act, would seek to reauthorize substance-use disorder (SUD) prevention and treatment programs initially enacted under the original SUPPORT for Patients and Communities Act in 2018, and would also work to build new systems to address newer opioids of concern, including a pilot program to use public health laboratories to detect fentanyl or other “synthetic opioids,” provisions related to the emerging use of xylazine as an illicit-use drug, and a provision to review the scheduling of buprenorphine and naloxone combinations.
• Several of the individual bills reauthorize specific research programs, including the National Institutes of Health’s Pediatric Research Initiative, Sickle Cell Disease and other heritable blood disorders research, efforts on maternal mortality at HHS, and programs to support both pre-term infants and their parents; this last bill would also direct HHS to commission a study from the National Academies that could make recommendations on the development of treatments or interventions for pre-term birth, including “precision medicine and preventive care approaches” for the infants themselves.
• A National Plan to End Parkinson’s: This bill, which has a long list of co-sponsors, would direct HHS to establish a “national project to prevent or cure Parkinson’s, ameliorate its symptoms, or slow or stop its progressions.” This would include federal support to “encourage the development” of treatments of preventive measures, as well as diagnostics and create an advisory council of federal entities – including members form the FDA, CDC, NIH and Centers for Medicare and Medicaid Services – to direct the work under the strategy.

What’s next, and what’s missing?

• Notably absent from the House markup: Priority review voucher (PRV) reauthorization. The PRV system was established under the 21st Century Cures Act in 2016. However, the reauthorization of that authority is not currently in PAHPRA, and POLITICO recently reported that the House leadership negotiating the reauthorization indicate it’s not likely to be included in the PAHPRA reauthorization on the House side. This is a deviation from the Senate HELP discussion draft, which included the provision not only to reauthorize the PRV program but to double the vouchers granted per each countermeasure authorization. However, as AgencyIQ noted at the time, that provision was only supported by the Ranking Member, and was not considered bipartisan. Going forward, the PRV reauthorization may be a standalone bill to continue the program.
• Also missing? FDA’s legislative priorities. As AgencyIQ has previously discussed, the FDA’s leadership viewed the impending PAHPA reauthorization as a second chance to get its legislative priorities through after some key provisions were not included in the end-of-year omnibus reform bill. As noted in the POLITICO story above, however, it appears that House Republican leadership are committed to keeping the PAHPA reauthorization as narrow as possible, in order to help ensure its passage. This means that FDA’s policy wish list is not on the agenda.
• House Democrats now appear to be calling out the lack of FDA policy. In a new press release entitled “REALITY CHECK: PAHPA HAS ALWAYS INCLUDED FDA POLICY,” E&C health Ranking Member (and former chair) Rep. Frank Pallone (D-NJ) raised concerns that the PAHPA reauthorization, as put forward by the House Republican leadership, does not include provisions on the supply chain or to address and respond to drug and medical device shortages. He cited five specific bills supported by Democrats on the committee that would be intended to bolster the supply chain and mitigate or prevent shortage that were put forward for consideration at this markup but not accepted by the subcommittee leadership. While Democrats in the House may push for a more expansive PAHPRA package, or try to offer their bills at the markup, it seems that the Republican Leadership is trying to keep the bill small to ensure that it’s passed before the October 1, 2023 deadline – and that FDA-related policy might not make the cut this time.
• Republicans have also indicated that legislation focused on drug shortages is proceeding separately. In a statement on July 12, House E&C Chair Cathy McMorris Rodgers (R-WA) announced that the committee intends to soon “circulate a drug shortage discussion draft following the completion of a bicameral request for information,” which yielded more than 100 responses for policy proposals.

To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com).
To contact the editor of this item, please email Alexander Gaffney ( agaffney@agencyiq.com)

Key Documents and Dates

• Markup announcement
• Hearing scheduled for July 13, 2023
• Press release from Rep. Pallone (D-NJ)