A big-name drug pricing hire at HHS

HHS has made a notable hire to advise its brand-new bureaucracy implementing Democrats' drug pricing reform law, according to an HHS staff directory listing.

Rena Conti, a health economist at Boston University who has focused on drug pricing issues in her research, is now listed as an adviser to the new group. Conti has published research on drug pricing reform models.

The hire brings the total number of staff employed under the Medicare Drug Rebate and Negotiation Group to 19 (though one other individual listed in the directory told STAT the listing wasn't correct). Medicare staff told Congress last year that the agency would be trying to hire up to 95 full-time employees. The group still doesn't have a director or a deputy director listed. CMS said the agency doesn't comment on specific personnel actions.

outside the beltway

What are biotech investors and CEOs thinking about the IRA?

I spent the first half of this week listening to panels and mingling with investors and executives at early-stage biotech companies at BIO's CEO & Investor Conference smack dab in the middle of Times Square. A couple of my top takeaways:

A partner at investing giant OrbiMed laid out how his calculations are changing for choosing biotech investments after the Inflation Reduction Act. He detailed how some therapeutic areas are particularly disadvantaged, and threw cold water on the idea that drugmakers could just hike launch prices to make up profits. More here.
One thing that surprised me was that among the smaller-scale investors and small biotech executives I chatted with, most weren't very familiar with the IRA at all — I had to explain key provisions to them. In a comment that summed up the sentiment, Matthew Gline, the CEO of Roivant Sciences, said that being included on a drug price negotiation list isn't a huge concern to companies concerned about even getting to market. "That's an upside scenario relative to not knowing whether the drugs will be approved or not," he said.

oversight

What you missed from the Biden administration's testimony on the Hill

House Republicans' promises to hold hearings with Biden administration officials came to fruition Wednesday, with FDA Commissioner Rob Califf, CDC Director Rochelle Walensky, and NIH Interim Director Larry Tabak testifying. ASPR Dawn O'Connell was scheduled to testify, but couldn't attend because of a death in her family. Republicans lobbed questions about masking recommendations in schools, the amount of virtual meetings agencies hold, restrictions on the cruise industry, and federal spending. A few moments that stood out:

Califf told Rep. Anna Eshoo (D-Calif.) that he is looking at ways to "optimize" the role of advisory committees, but he thinks they have a "critical" role in the FDA's decisionmaking process. Walensky defended the committees as well, saying they have "incredible value."
Rep. Bill Johnson, an Ohio Republican, stumped Walensky with questions about how much money the CDC has spent on contact tracing efforts, and what the people hired to do that work are doing now. The agency's contact tracing webpage hasn't been updated since early 2022.
Rep. Michael Burgess (R-Texas) cited my colleague Lev Facher's reporting about an NIH oversight panel that hasn't met since 2015, and asked Tabak where the hundreds of thousands of dollars per year to maintain the panel and costs for two full-time employees are going. Tabak said he'd check back with Burgess.
Tabak also laid out the next steps following proposals by biosecurity, ethics, and infectious disease experts to bolster government oversight of pathogen research that could make viruses more transmissible. Once the proposals are finalized, Tabak will write a memo to HHS Secretary Xavier Becerra, who will then consult the White House, and then the framework will be implemented.

pHE watch

Medicare's post-emergency plan

The end of the public health emergency will bring a lot of changes, including what patients can expect to pay when they visit the doctor's office or go to the pharmacy.

Last week, I wrote about the uncertainty around what patients on various insurance policies could be expected to pay for Covid-19 tests, vaccines, and treatments. Since then, Medicare officials got back to me with an outline of what their plan will be for patients.

The gravy train for free over-the-counter tests will end, but seniors will still have cost-sharing protections for some lab tests and vaccines, the agency said. Read all the details in the story out this morning.

Lobbying

Musical (board) chairs at PhRMA

vas-phrma

Alissa Ambrose/STAT

PhRMA got a new board chair, as Novartis CEO Vas Narasimhan assumed the role Wednesday. He's taking the role over from Takeda CEO Ramona Sequeira. And on an investor call on Feb. 1, Narasimhan laid out three of his most urgent priorities as PhRMA's board chairman.

Top of the list is changing the differential negotiation eligibility timeline between small-molecule drugs (starts nine years from FDA approval or licensure) and biologics (starts after 13 years).

"I think the key thing will be when, in the coming years, there's a legislative vehicle for us to be able to pursue that. But it's a top priority of the industry. And I think, at least my belief is our industry, when we come together, to really focus on a topic and have a very clear compelling policy case and a relatively small pay-for from a congressional standpoint, that we can make it happen. That's going to be our total focus as a sector in the U.S.," he said.

The other two issues Narasimhan mentioned were pharmacy benefit manager reform and focusing the 340B program on low-income patients. Two pharmaceutical industry titans also got new board titles: Gilead CEO Daniel O'Day is board chair-elect, and Pfizer CEO Albert Bourla will serve as the board's treasurer.

More around STAT

Check out more exclusive coverage with a STAT+ subscription

Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we're reading

Verily, struggling to turn profits, taps a Starbucks veteran and 'Warcraft' master, STAT
Mpox is simmering south of the border, threatening a resurgence, Politico
Pharma loses a court battle in its bid to block states from importing drugs from Canada, STAT
Catholic health care restrictions lead Washington Legislature to eye changes, Seattle Times