By Lauren Gardner and David Lim

Presented by Blue Cross Blue Shield Association

With Ben Leonard

Now that President-elect Donald Trump (left) has picked Robert F. Kennedy Jr. to lead HHS, speculation has turned to who he will choose to take the helm at the FDA. | Alex Brandon/AP

MORE ON MAKARY — President-elect Donald Trump’s transition team has zeroed in on Dr. Marty Makary as the top target to lead the FDA during his second term. Your morning hosts staked out senators Thursday to take their temperatures on the Johns Hopkins surgeon and vocal critic of the Biden administration’s Covid-19 response.

Sen. Bernie Sanders (I-Vt.), chair of the Health, Education, Labor and Pensions Committee and in line to be the panel’s ranking member next year, didn’t tip his hand on whether he would support Makary if Trump nominates him.

“There’s a process to evaluate — the president has a right to make nominations — our job is to evaluate them,” Sanders said.

Makary received high marks from one senior Republican panel member.

“Great guy, impeccable credentials, academia, patient medicine and also a real believer in patient freedom,” said Sen. Rand Paul (R-Ky.), who said he would support Makary if he were picked to lead the FDA.

Makary has a record of criticizing Dr. Anthony Fauci, the former National Institute of Allergy and Infectious Diseases director who famously sparred with Paul during the pandemic.

But other senators said they weren’t familiar with Makary’s record.

“I have no clue about him,” said Sen. Tommy Tuberville (R-Ala.).

That was echoed by certain Democrats on the committee, including Sens. John Hickenlooper (D-Colo.) and Tammy Baldwin (D-Wis.).

“I don’t know anything about him,” Hickenlooper said.

An adviser’s view: Shortly after the election, Lauren chatted with Dr. Cody Meissner, an independent vaccine adviser to the FDA during the pandemic, about Makary’s rising star.

“He deals with issues that some people might see as controversial, but yet he is able to pull together two sides and work out a reasonable compromise,” Meissner said.

Meissner, now a pediatrics professor at Dartmouth’s medical school, co-wrote an August 2021 op-ed with Makary opposing mask mandates for children. They also shared similar opinions about vaccinating children against Covid, questioning whether the benefits of multiple doses t outweighed the risks.

While Meissner said he thinks politics bled into the Covid vaccine debate, he praised the work of the FDA’s and the CDC’s independent advisers on evaluating the shots’ safety — and suggested Makary would have no problem making his views known, should he be commissioner.

“It's important that we stick to the scientific data that’s been generated by vaccines,” he said. “Marty Makary is a very compelling speaker and is very thoughtful. He can always back up his recommendations either by his own work or by the work of others.”

Joe Grogan, Trump’s former director of the Domestic Policy Council, took a shot at FDA Commissioner Robert Califf on Thursday, backing Makary.

“Unlike statists who absurdly think @fda is operating at ‘peak performance’ Marty would bring change and transparency,” Grogan posted on X, mocking comments Califf made last week at a cancer research conference.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Bill Nye told Lauren he thinks Robert F. Kennedy Jr. has “lost his way.”

Send tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

A message from Blue Cross Blue Shield Association:

When corporate hospitals buy up independent physician practices, they mark up prices to unreasonable levels, helping their bottom line—and hurting patients. These price increases translate to higher premiums and out-of-pocket costs. Commonsense policy solutions can help ensure no patient pays more for the same services at the doctor’s office simply because a hospital renamed the building. See how Blue Cross and Blue Shield companies are working to make health care more affordable for all.

A compounding pharmacy group is challenging the FDA's decision to remove tirzepatide, the active ingredient in Eli Lilly's weight-loss drugs, from its drug shortage list. | Scott Olson/Getty Images

FDA: STILL WORKING ON GLP-1 SHORTAGE — The FDA “has made substantial progress reevaluating” its decision to pull the diabetes and weight-loss drug tirzepatide from its shortage list, the agency said Thursday in a status update to a federal court in Texas.

The Outsourcing Facilities Association, which represents large compounding pharmacy sites that can make copies of brand-name GLP-1s when they’re in shortage, sued the FDA last month in the U.S. District Court for the Northern District of Texas. The group argued the agency should have conducted a notice-and-comment rulemaking when pulling the active ingredient in Eli Lilly’s Mounjaro and Zepbound from the list on Oct. 2.

The association, its members and others have submitted “evidence that the drug remains in shortage” to the FDA.

“Pharmacy distributors continue to list branded Tirzepatide products as out-of-stock or available in only limited quantities,” OFA said in its report. “Meanwhile, production of compounded Tirzepatide products by members of Plaintiff Outsourcing Facilities Association has remained steady or grown, reflecting still more market demand and medical need that is unable to be met by branded Tirzepatide products.”

Next up: The parties agreed the case should remain stayed and said they intend to file another status report by Dec. 19 or within a week of the FDA’s updated decision, whichever comes earlier.

PATENT BILL ADVANCES — The Senate Judiciary Committee narrowly approved a bill 11-10 Thursday that would overhaul the patent review process at the Patent Trial and Appeal Board, an effort that patient advocates and generic drugmakers say would make it harder for them to challenge branded manufacturers’ exclusivity claims.

The panel endorsed a manager’s amendment that bill sponsor Sen. Chris Coons (D-Del.) said would “explicitly” ensure those parties would have standing at PTAB to challenge drug patents. Democrats like Sens. Amy Klobuchar (D-Minn.) and Richard Blumenthal (D-Conn.) suggested their support on the floor would hinge on proponents being able to further show that the legislation wouldn’t lead to higher drug prices.

BIOSECURE STATE OF PLAY — Sen. Rand Paul’s (R-Ky.) persistent opposition to the BIOSECURE Act is complicating the path forward for the legislation cracking down on Chinese biotech firms, Ben reports.

Lawmakers — including House Speaker Mike Johnson and retiring Rep. Brad Wenstrup (R-Ohio) — are preparing a last-ditch effort to get the BIOSECURE Act signed into law with weeks left in this Congress. But Paul fears that anticompetitive motivations may be at play, saying people are “taking advantage of anger towards China” to take “parochial, protectionist” measures.

Although the legislation has strong support, congressional tradition typically requires approval from the chairs and ranking members of the relevant committees to get provisions attached to a must-pass bill. Paul is the incoming ranking member of the Homeland Security Committee.

Fissures elsewhere: The House passed the bill in a 306-81 vote in September. Still, more than a third of House Democrats voted against the bill after Rep. Jim McGovern (D-Mass.) panned the legislation, saying there isn’t sufficient due process for the named companies.

Wenstrup and others warn that Beijing could use some named firms in the bill to obtain sensitive information like Americans’ genomic data. The companies have pushed back, saying they don’t pose a threat.

One of the most likely paths forward for the legislation is on the annual must-pass defense policy legislation, though it hasn’t been included in drafts of the package yet.

A message from Blue Cross Blue Shield Association:

The FDA issued final guidance outlining its expectations for its third-party 510(k) review program and emergency use authorization review by the outside bodies.

The FDA issued final guidance outlining performance criteria for non-spinal metallic bone screws and washers. It also issued final guidance for 510(k) submissions for those products and non-spinal bone plates.

The FDA should loosen restrictions on antipsychotic drug clozapine, the agency’s outside advisory committee voted Tuesday.

Michael Pollan wants people to know he doesn’t believe Robert F. Kennedy Jr. is qualified to be HHS secretary, POLITICO’s Katelyn Fossett reports.

The Multidisciplinary Association for Psychedelic Studies can move forward with a clinical trial on cannabis for treating veterans with PTSD after getting permission from the FDA, POLITICO’s Mona Zhang reports.

A message from Blue Cross Blue Shield Association:

A root cause of the health care affordability crisis is the growing trend of corporate hospital systems taking over small physician practices and reclassifying them as hospital outpatient departments. Even though it’s often the same service, with the same doctor, in the same location, the simple name change can dramatically increase costs—in some cases quadrupling a patient's bill.

If that trajectory continues, affordable health care will be out of reach for many Americans and their families.

It’s time to stop putting hospital systems’ profit over patients. Fair hospital pricing could save Americans nearly $6 billion over 10 years—see how Congress can help.

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David Lim @davidalim Lauren Gardner @Gardner_LM

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