As Congress races against the clock to reauthorize the Pandemic and All Hazards Preparedness Act, the law that lays the foundation for the nation’s biosecurity policy and emergency public health response, a slew of contentious policy proposals vying for inclusion could threaten to derail the bill’s passage.
Lawmakers have until Sept. 30 to renew the law — first enacted in 2006 and most recently renewed just before the COVID-19 pandemic in 2019 — or it will expire. But with only two weeks left until the August recess and a tight legislative calendar when lawmakers return before the end of the fiscal year, that deadline is closer than it looks.
So far on the House side, a bare-bones version of the legislation advanced along party lines out of its subcommittee and is heading to a vote by the Energy and Commerce Committee. Meanwhile, the Senate Health, Education, Labor and Pensions (HELP) Committee plans to markup and potentially advance its version of the bill that includes a number of bipartisan compromises on controversial provisions.
Once both committees advance their respective copies, they will still need to pass whole chamber votes. Then, any differences between the two versions, of which there are currently many, will need to be worked out before the chambers vote on the finalized legislation. And it’s yet to be seen whether representatives in the fractured House will agree to any new amendments proposed by the Senate.
Fighting over provisions in the law led former Sen. Richard Burr and former CDC Director Julie Gerberding to recently pen an op-ed arguing that “only a ‘lean’ PAHPA that includes straightforward reauthorizations for expiring authorities and programs with minimal policy or programmatic changes,” could pass.
With tensions high, here’s a look at some of the controversial amendments being hashed out and where their inclusion in the legislation currently stands.
More drug pricing
Much to the dismay of industry groups, Sen. Bernie Sanders, chair of the Senate HELP Committee, proposed in a PAHPA discussion earlier this month a new drug pricing policy that would require medicines developed with taxpayer money — through grants from BARDA and the NIH — to be sold to the U.S. government and on the commercial market at the lowest price charged in G7 countries.
Republicans and drug industry lobbying groups pushed back on the measure. BIO argued it would “effectively shut down public-private partnerships.” And PhRMA said a similar “reasonable pricing” policy imposed by the NIH “on collaborative agreements between federal labs and outside parties” failed in the 1990s because it chilled collaboration.
In a copy of the markup legislation provided to PharmaVoice, it appears the Senate committee has come to a compromise on the provision. While Sanders’ pricing model isn’t included, a new measure grants the National Academies $3 million to conduct a study on “alternative models for directly funding, or stimulating investment in, biomedical research and development that delink R&D costs from the prices of drugs.”
If enacted, the provision will require the National Academies to host two public listening sessions and publish the report within two years of PAHPA’s reauthorization. But the House version of PAHPA does not include a similar amendment, and it remains unclear if it will make it into a finalized version of the legislation.
Priority review voucher program
On the Republican side, Sen. Bill Cassidy, ranking member of the Senate HELP Committee, pushed for an extension and expansion of the FDA’s medical countermeasure priority review voucher program, which gives companies developing drugs for tropical diseases, rare pediatric conditions and emergency countermeasures expedited review and, upon approval, an extra fast-track pass for a future drug.
Cassidy hoped to expand the program by giving companies with approved drugs an extra, non-transferable voucher. However, the provision received criticism as a handout to drug companies that could inadvertently slow investment.
The Senate’s current draft renews a clean version of the program, without the extra voucher, until 2028.
Getting the proposal past the House could prove difficult, though, as Republicans in the chamber have so far refused to add any FDA-related provisions to PAHPA, arguing that they are unrelated to the bill’s purpose.
Preventing drug shortages
For similar reasons, the senators might have a difficult time convincing their House counterparts to include measures related to drug shortages in a final PAHPA reauthorization.
From Adderall to cancer drugs to antibiotics, supply chain hiccups have constrained access to over 200 medications this year, putting patient’s lives at risk. The Senate’s markup copy of PAHPA attempts to address the problem by requiring drug manufacturers to notify the HHS six months before expected interruptions or stoppages in the production of drugs and active pharmaceutical ingredients, or other situations that could impede supplies. Under the guidelines, drugmakers would need to explain the reasons for the interruption, the expected duration and alternative ways to quickly fix the problem.
The European Union suggested a similar policy in an overhaul of its pharma law, which was blasted by industry groups who said it is impossible to predict supply chain issues months in advance.
And while Democrats in the House advocated for similar policies in their PAHPA discussions, Republicans on the House Energy and Commerce Committee refused to include the measures in their version of the bill, arguing that it was an FDA-related policy.
The measure likely faces an uphill climb for inclusion in the final PAHPA bill.
Combatting antimicrobial resistance
Over 200 industry groups and nonprofit organizations have urged Congress to include the Pioneering Antimicrobial Subscriptions to End Up Surging Resistance, or PASTEUR Act, in the PAHPA reauthorization.
"We want to see PASTEUR passed regardless of what the legislative vehicle is."
Director of antimicrobial resistance research, The Pew Charitable Trusts
The bill, which has been introduced three years in a row, proposes a subscription-based funding model for antibiotics that would require the government to pay drug companies a flat annual rate for novel antibiotics based on their value to public health. The measure is intended to spur development of the needed but often unprofitable medications.
To the distress of antibiotics developers, PASTEUR will likely need to find another way. The act is not included in either the House or the Senate’s current versions of the bill, and lawmakers don’t appear keen to tack on the additional $6 billion needed to fund the program.
The Senate’s draft does extend the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria, which provides recommendations on tackling antimicrobial-resistant bacteria challenges to the HHS Secretary and Congress.
As for PASTEUR, David Hyun director of antibiotic resistance research at The Pew Charitable Trusts, said activists aren’t giving up.
“We want to see PASTEUR passed regardless of what the legislative vehicle is,” he said. “If it’s not included in PAHPA, we will still continue to advocate for this to be included in any other legislation that's relevant.”