From PBMs to Biosecure, a conversation with Rep. Auchincloss on The BioCentury Show
The newly minted member of Energy & Commerce has a deep understanding of the biomedical innovation ecosystem
Rep. Jake Auchincloss (D-Mass.), an influential voice in Congress on life sciences issues, gained stature last week when he was appointed to serve on the Energy & Commerce Committee, giving him a seat at the table for debates over legislation affecting FDA, CMS and NIH and a host of issues of critical importance to the biopharma industry.
Representing a district that stretches from the Boston suburbs to the Rhode Island border and is home to many of the scientists, investors and entrepreneurs who work in the Cambridge biotech hub, Auchincloss has a deep understanding of the biomedical innovation ecosystem.
In an interview with The BioCentury Show, Auchincloss outlined his priorities for the 119th Congress, from pushing “muscular” PBM reform over the congressional finish line to finding bipartisan support for refining the IRA's orphan drug exemption and advancing methods to evaluate the social value of medicines.
He expressed strong opposition to confirming Robert F. Kennedy Jr. as HHS Secretary, relief that the Biosecure Act fizzled out in the 118th Congress, and support for methods of assessing the value of medicines that consider broad social benefits and generic competition.
Given Republicans’ paper-thin majority, House members like Auchincloss who understand complex domains — in his case, biomedical innovation policy — and have a willingness to reach across the aisle to craft bipartisan legislation will be influential in 2025 and 2026.
“I’d like to see Generalized Cost Effectiveness Analysis become the norm for how we assess value.”
Auchincloss has personal ties to the life sciences. His mother, Laurie Glimcher, served as president and CEO of Dana-Farber Cancer Institute from 2016 to 2024, His father, Hugh Auchincloss, led NIH’s National Institute of Allergy and Infectious Diseases from 2022 to 2023, following the resignation of Anthony Fauci.
Starting with his first congressional campaign in 2020, Auchincloss has received financial support from the biotech sector. Employees of RA Capital, Deerfield Management and Bain Capital were among the top five contributors to Auchincloss’ political action committee, Beyond Thoughts & Prayers, in 2023-24, according to Federal Election Commission data aggregated by Open Secrets.
In contrast to some members of Congress who represent districts and states with heavy concentrations of innovative biopharma companies, Auchincloss has taken a strong interest in the bioeconomy. He has also embraced Democratic positions on drug pricing, including the Inflation Reduction Act’s Medicare drug price negotiation program and called for robust NIH funding.
Auchincloss told BioCentury he views policy issues related to the U.S. bioeconomy through three lenses: the need for the federal government to be an “impact investor” in basic research; the government’s role as a “smart regulator;” and its role as a provider of health insurance.
He has led bipartisan congressional efforts to constrain PBMs by changing their business models.
PBM reform
The last-minute decision by House Speaker Mike Johnson (R-La.) to pull a bipartisan PBM reform bill from a must-pass spending bill in December was “devastatingly disappointing,” Auchincloss told BioCentury.
The bill would have prevented PBMs from linking their fees to the cost of Medicare Part D drugs, prevented PBMs from charging their clients higher prices than the net prices they negotiate with drug companies, and increased transparency around PBM business practices.
Although Johnson “folded at the last minute,” Auchincloss said he is optimistic about the prospects for PBM reform in the new Congress.
He is pushing for legislation that goes farther than the bill Johnson yanked.
Auchincloss introduced the Pharmacists Fight Back Act in the 118th Congress. The bill, which attracted 60 co-sponsors across party lines, is “probably the most muscular PBM reform ever introduced at the federal level,” Auchincloss told BioCentury. It seeks to “beat back the middlemen of drug pricing. They are rent seeking, taking about $300 billion out of the U.S. healthcare system through the gross-to-net bubble every single year, and they’re creating no value.”
The legislation seeks to mandate a cost-plus pricing model for federal health programs, and to require that PBMs share 80% of rebates with beneficiaries of federal insurance programs at the pharmacy counter.
There are signs that the Trump administration may be receptive.
In December, Pfizer Inc. (NYSE:PFE) CEO Albert Bourla, Eli Lilly and Co. (NYSE:LLY) CEO Dave Ricks, and PhRMA CEO Steve Ubl met at Mar-a-Lago with Trump, incoming White House Chief of Staff Susie Wiles and RFK Jr. The CEOs told colleagues they had at least a tentative agreement on the need for PBM reform.
Paying for value
While he wants to curb PBM business practices that inflate drug prices, Auchincloss also believes that government, which purchases healthcare products and services through Medicare, Medicaid, and for active duty and retired military service members, should do a better job of demanding and paying for value.
“That means rigorous assessments of which interventions are producing societal value, which are not, and reimbursing accordingly,” Auchincloss said.
He expressed strong support for a framework for assessing value, Generalized Cost-Effectiveness Analysis (GCEA), that Peter Kolchinsky, managing partner at RA Capital Management, and a non-profit he founded, No Patient Left Behind, have advocated for on Capitol Hill and in academic settings.
“I'd like to see Generalized Cost Effectiveness Analysis become the norm for how we assess value,” Auchincloss said. He noted that GCEA differs from cost effectiveness analyses conducted by England’s National Institute for Health and Care Excellence (NICE) and the Institute for Clinical and Economic Review (ICER) in the U.S.
GCEA, he said, “does a better job of looking at the full spectrum of value that novel biomedical or medical device interventions can create” and, unlike other value frameworks, it takes into account the economic consequences of patent expirations, including generic and biosimilar competition.
Bipartisan support for limited IRA reform possible
Loss of exclusivity and robust generic competition for small molecule drugs that causes prices to plummet are critical to creating health equity, Auchincloss said.
He acknowledged concerns about the structure of the Medicare drug price negotiation program, which disincentivizes small molecule drug development in favor of biologics. “There is nothing more equitable in healthcare than a small molecule drug that goes generic, because it becomes available to everybody for pennies.”
Although he did not commit to endorse legislative fixes for the IRA’s “pill penalty,” Auchincloss said he is open to seeing evidence that it is having unintended negative consequences. “Are we seeing drug R& D being diverted, particularly from small molecule indications, towards large molecules, or just discontinued entirely? Because we don’t want to see that. We don’t want to stop new cures in their tracks.”
As BioCentury has reported, a recently published analysis indicates that the IRA is depressing early-stage investments in small molecules, and early-stage investments of both small and large molecules in therapies to treat conditions that primarily affect Medicare populations.
Auchincloss said there could be bipartisan support for changes to the single orphan-designation exemption from the Medicare drug price negotiation program.
He opposes, however, legislation introduced in the 118th Congress that would grant an exemption to drugs that only have orphan indications, regardless of the number of indications. Instead, Auchincloss said he and other Democrats would support exempting a drug that has only orphan indications, provided that the exemption expired when the total patient population for a drug exceeded 200,000 Americans.
‘A quack and a conspiracist’
While he outlined areas of potential agreement with Republicans, Auchincloss made it clear that he is appalled by some of Trump’s personnel choices.
Auchincloss is particularly outspoken in his denunciation of Trump’s pick to head HHS.
“RFK is a quack and a conspiracist who has no place near the levers of influence with health and human services,” he told BioCentury. “I am concerned that he's going to fuse his own personal brand with the organs of state.”
Kennedy’s role in leading an anti-vaccine campaign in Samoa in2019 that fueled a measles outbreak that killed 83 people, mostly children, disqualifies him from any position involving public health, Auchincloss said. The incidence “demonstrates that he is not just an ignorant individual, he is a reckless and dangerous one as well.”
The danger involves both actions Kennedy could take as HHS secretary and the negative impacts on vaccination that could result from placing an anti-vaxxer in a position where he would influence public opinion, Auchincloss said. He noted that the measles vaccination rate is “hovering at or below herd immunity rates” in five states. “With the wrong kind of messaging, you can see those plummet, and you can see measles outbreaks, and children will die, and they will die in pain.”
“RFK is a quack and a conspiracist who has no place near the levers of influence.”
Auchincloss said his concerns about Kennedy’s anti-vaccine positions are amplified by President-elect Donald Trump’s choice to run the CDC, former Representative Dave Weldon. Weldon has a long history of repeating debunked claims about connections between vaccines and autism.
“When you look at the alignment between the Office of HHS Secretary, which will be filled with anti-vax lawyers, and the CDC, which is going to be helmed by an anti vax-crusader, I’m significantly concerned about undermining this country’s ability to produce and then distribute vaccines,” Auchincloss said.
Auchincloss called on Republicans to vote against confirming Kennedy and expressed concern that some Democrats will also endorse him. “To me, a Democrat who votes for RFK is undermining the party’s commitment to science and to children's public health.”
On the other hand, Auchincloss expressed confidence in Trump’s choices to lead other public health agencies. Marty Makary, Trump’s FDA commissioner pick, and Jay Bhattacharya who is seeking confirmation as NIH director, “are scientists who respect evidence and have the esteem of their peers, even though there have been vigorous disagreements in the past,” Auchincloss said.