What Flick’s hire at HHS means for the FDA

Jan 14, 2025

With help from Carmen Paun

Driving The Day

Robert F. Kennedy Jr. walks in the in the U.S. Capitol.

A new HHS chief of staff has been chosen for Robert F. Kennedy Jr., who will lead the agency if confirmed by the Senate. | Francis Chung/POLITICO

FLICK’S FDA IMPACT — The decision by President-elect Donald Trump’s team to tap Heather Flick as HHS chief of staff signals an effort to keep closer watch on the department and its activities.

As Adam Cancryn and I scooped on Monday, Flick, a former senior HHS official during the first Trump term, points to a more concerted effort by senior Trump aides to keep a closer watch on the department and its activities amid suggestions from some Robert F. Kennedy Jr. allies that HHS could advance the priorities of the broader, more Kennedy-centric Make America Healthy Again movement. Kennedy is Trump’s pick to lead HHS.

Flick will likely be tasked with being the point of contact at HHS for any hot-button issue — such as abortion pills, flavored tobacco products and laboratory-developed tests — that is being lobbied over, according to Marc Scheineson, former FDA associate commissioner for legislative affairs.

“It’s sort of the Trump guys’ eyes and ears within the department, too; it’s a very important liaison and information source,” said Scheineson, who now works as senior counsel at Alston & Bird. “The chief of staff, they kinda lay down the law.”

Flick has long been involved in Republican politics and served in a range of top roles at HHS during the first Trump administration. She was initially the department’s acting general counsel before becoming its acting secretary for administration and a senior adviser to then-HHS Secretary Alex Azar.

A former FDA official granted anonymity to discuss Flick’s role said that depending on how interested HHS secretaries are in the agency’s work, their chief of staff “can be very, very involved in FDA business and FDA work.” Longtime readers — or even those new to health care policy — can surmise that Kennedy is quite interested in FDA policy.

“On really high-profile things, if she’s an effective chief of staff, she could be super involved,” the former official said. “I certainly saw that happen across multiple administrations.”

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Your authors enjoyed the snow but won’t be sad to see the ice on sidewalks across the nation’s capital melt away.

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

Eye on the FDA

A woman holds a dosage of Wegovy, a drug used for weight loss, at her home.

Some drug companies are looking to pair GLP-1 weight-loss drugs like Wegovy with apps that could improve patient success. | Amanda Andrade-Rhoades/AP

PDURS PATTER — Noom, the weight-loss digital company that has urged policymakers to address the high price of brand-name GLP-1 drugs, unveiled a software update Monday that it says could be a model for the FDA to consider as pharmaceutical companies look to app add-ons to their labels to improve patient safety and outcomes.

The update follows September 2023 draft guidance in which the FDA described how it plans to consider software applications that companies want to add to their drug labels to differentiate their products, known as prescription drug use-related software, or PDURS.

Why it matters: Offering a clinically tested software option in tandem with a drug could improve patient adherence to medications both within and beyond the GLP-1 class, Noom CEO Geoff Cook said, which has well-known gastrointestinal side effects that drive some users to quit use — and regain weight. App updates include a meal planner and a side-effect tracker to help boost the behavioral change aspect of the drugs’ indicated use — diet and exercise.

Getting software added to a drug label has historically meant firms would need to conduct a Phase III trial comparing the drug-software combination against medication use without the technological assistance. Cook said the PDURS framework would essentially allow companies to test the combo products in Phase IV studies when the drug is already on the market, making it less costly for firms to pursue clinical evidence supporting the use of their digital platforms.

“We believe that there’s going to be kind of a gold rush toward these digital solutions — not just in GLP-1s … but that pair with a medication,” he told Lauren ahead of the announcement. “The fundamental thing here is that these pharma companies are going to be looking for different ways to distinguish themselves in a crowded market.”

Industry Intel

J&J TO BUY INTRA-CELLULAR THERAPIES — Johnson & Johnson struck a deal to buy Intra-Cellular Therapies for $14.6 billion, the company said Monday.

The deal — which centers on Intra-Cellular’s schizophrenia and depression treatment Caplyta — is expected to close later this year.

AROUND THE AGENCIES

FTC REFUNDS PHONY N95 MASKS — The Federal Trade Commission said Monday it will send more than $1 million in refunds to consumers who bought “deceptively marketed” Zephyr face masks during the Covid pandemic.

The agency announced a proposed settlement in April in which Razer Inc., the company behind the masks, would issue full refunds and pay a civil penalty for falsely advertising those masks as N95 or N95-equivalent when they were never certified by the FDA or labor regulators.

PBM WATCH — The FTC will hold an open meeting Tuesday that tentatively includes consideration of a second interim staff report regarding the agency’s study of pharmacy benefit manager contracting practices.

A bipartisan quartet of lawmakers — Sens. Elizabeth Warren (D-Mass.) and Josh Hawley (R-Mo.) and Reps. Diana Harshbarger (R-Tenn.) and Jake Auchincloss (D-Mass.) — urged the commission Thursday to release the report “and continue investigating the serious effects of the PBM industry on patients, taxpayers, and independent pharmacies.”

OTC BIRTH CONTROL RULE PULLED — HHS and the departments of Labor and Treasury pulled an October proposal Monday that would have required Affordable Care Act plans to cover certain preventive services, such as over-the-counter contraceptives, without cost-sharing. Preventive services coverage under the law, as well as reproductive health policies, are likely to receive scrutiny from the incoming Trump administration.

COVID HEALTH STANDARD AXED — The Occupational Safety and Health Administration said Monday it would end efforts to impose a Covid safety standard in health care settings, POLITICO’s Nick Niedzwiadek reports.

The final rule had languished at the White House’s Office of Information and Regulatory Affairs since early December 2022.

MEDICAL DEVICES

OPIOID TEST PRODUCER HITS BACK — The company behind a genetic test to predict the risk of opioid addiction in people before they’re prescribed opioid pain medicine hit back at a study released last week claiming the test might not be more effective than a coin toss, Carmen reports.

“The researchers in the recent JAMA publication did not have access to our technology (AvertD); therefore, any comparisons or conclusions in the article to AvertD are invalid,” said Ron McCullough, senior vice president of clinical operations at SOLVD Health, which owns AutoGenomics, the test producer.

The study results showed that the genetic variants researchers said underpin the test were accurate in about 53 percent of the cases. Researchers acknowledged they didn’t have access to the algorithm that determines the risk because it’s proprietary and noted that was a limitation of their study.

McCullough also pointed to researchers’ conflict of interest disclosures, which show some of them working on technology similar to the AvertD test.

“We encourage independent experts to evaluate these discrepancies and remain committed to advancing proactive healthcare solutions addressing the opioid crisis,” he said in an email to Prescription Pulse.

Pharma Moves

HHS announced hires Monday for three high-level tech positions. Alicia Rouault, previously a United States Digital Service official, is chief technology officer and associate deputy assistant secretary for technology policy; Dr. Meghan Dierks, formerly chief data officer at Komodo Health, is chief artificial intelligence officer; and former HHS chief data scientist Kristen Honey as chief data officer.

The FDA’s director of the Center for Drug Evaluation and Research, Dr. Patrizia Cavazzoni, is stepping down at the end of the week.

Document Drawer

The FDA updated guidance Monday on the modular review program for premarket approval applications and humanitarian device exemptions.

WHAT WE'RE READING

According to a new study, 40 percent of adults are likely to develop a form of dementia after age 55, The Washington Post writes.

Scientists have identified the gene in grapefruit that produces a compound that interferes with some common medications, The New York Times reports.

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