Bertagnolli stuck in drug pricing crosshairs

NIH director nominee Monica Bertagnolli fielded questions on everything from long Covid to obesity research during her long-awaited hearing Wednesday, but one question just kept coming up: How do you really feel about reasonable pricing requirements?

It was to be expected from Senate HELP Chairman Bernie Sanders (I-Vt.), who stalled her confirmation process in a bid for HHS to commit to reasonable pricing clauses, my co-author Sarah Owermohle reports. But Republicans, too, wanted to know just how far Bertagnolli would go with requirements after the administration inserted such a clause into a Regeneron deal last month, seemingly placating Sanders enough to hold a hearing.

Bertagnolli refused to commit to either party's approach but told Sanders that she believes Americans deserve a "fair return" on investment. She also parried with lawmakers looking for commitments on limiting or increasing gender-affirming care research, another sign of NIH's increasingly politicized portfolio.

Of interest for those following NIH's long Covid research program that's drawn criticism from patient advocates for moving too slowly and not focusing enough on testing therapeutics. Sen. Tim Kaine (D-Va.) pressed Bertagnolli on criticism of the program. She committed to working with Kaine, and said long Covid is "one of the greatest tragedies we have recently seen."

consumer health

The FDA's half-century food (additive) fight

The FDA still hasn't banned brominated vegetable oil, even though the agency issued its first warnings about the ingredient when Richard Nixon was president.

That might finally change soon, as the agency sent a proposed ban to the White House in August, STAT's Nick Florko writes. But food safety advocates view the decadeslong delay action as symbolic of how the regulatory system is too slow to be effective. Nick breaks down the delay in a new story out this morning .

stat live

STAT Summit's greatest hits

The first day of STAT Summit was packed with interesting conversations with scientists, executives, and patients, including a session with Mark Zuckerberg and Priscilla Chan and my conversation with biotech entrepreneur and health care price transparency advocate Cynthia Fisher. Here are a few tidbits relevant to Washington:

The CBO has said codifying most price transparency measures in a House bill on the issue will not save money, but Fisher challenged that idea, arguing it's already saving money. She detailed instances in which price transparency has already collectively saved significant sums of money for employers that used price transparency to limit their provider networks. Those include Rosen Hotels & Resorts in Florida, a Florida school district, and a Service Employees International Union in New York. The SEIU union could save more than $100 million over three years. "I love to prove people wrong," Fisher said.
Here's another quote to add to the file of pharma executive statements on the Inflation Reduction Act. Daniel Skovronsky, a top executive at Eli Lilly, said: "I think at Lilly, at least, and hopefully, at other big pharma companies, we don't stop drugs that are working because we're worried that they won't make enough money. But maybe we don't start programs."
Chan and Zuckerberg announced a new biohub in New York to build disease-fighting cellular machines, an investment of $250 million over 10 years. The biohub will consist of researchers at Yale, Columbia, and Rockefeller. My colleague Jason Mast has all the details.

speaker race

McHenry and private investors: You've got a friend in me

As House Republicans continue to play musical chairs with their speakership, we're doing our best to make sure you know what the potential scenarios could mean for health care. I don't have a crystal ball, but there has been some recent buzz around the possibility that Rep. Patrick McHenry (R-N.C.) may be empowered somewhat if Republicans can't figure out how to elect anyone else.

McHenry, like speaker candidates before him, is not a big health care guy. He's only sponsored one health care-related bill, which would have given state health departments the authority to approve diagnostic tests during a public health emergency.

But it's worth noting that McHenry is a big recipient of campaign donations from private equity and venture capital firms including Apollo Global Management, Andreesen Horowitz, and Capital Group Companies. Investment firms are influential when they choose to throw their weight around on health policy (remember surprise billing, anyone?). Biotech investors are trying to water down Democrats' new drug pricing law, and issues over a provision to force health care providers to disclose their private equity owners have stalled a price transparency package in the House.

business

UnitedHealth board chair owns a private investment firm

A private investment firm owned by the former CEO of UnitedHealth Group and its current board chair is raising questions about potential flaws that exist in the Securities and Exchange Commission's federal disclosure requirements, which Congress put into law in the 1930s and '40s.

Stephen Hemsley, the former CEO of UnitedHealth Group and its current board chair, also owns an investment firm that manages his own portfolio of UnitedHealth stock and oversees other wealthy individuals' accounts that have held shares of companies that have direct business with or indirect ties to United, my colleague Bob Herman reports.

UnitedHealth legally doesn't have to disclose the arrangement in its regular filings. "That's a shame that the public reporting laws are pretty narrow in their focus," said Andrew Verstein, a law professor at UCLA who studies corporate governance and insider trading. Read more from Bob.

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