RFK Jr. fields pharma questions on Day Two

Jan 31, 2025

Presented by Boehringer Ingelheim

Driving The Day

Robert F. Kennedy Jr. touches his forehead while testifying.

HHS secretary nominee Robert F. Kennedy Jr. struggled to answer questions about Medicare during his appearance before the HELP committee. | Rod Lamkey Jr./AP

RFK JR. IN THE HOT SEAT — After two days of making his case to Senate committees, Robert F. Kennedy Jr.’s bid to lead federal health agencies still appears to be in limbo.

Sen. Bill Cassidy (R-La.), chair of the Health, Education, Pensions and Labor Committee, indicated he’s grappling with his vote after imploring the HHS nominee to state there is no connection between vaccination and autism.

Kennedy struggled to answer questions about the differences between Medicare Parts A, B and C when questioned by Sen. Maggie Hassan (D-N.H.) — a day after appearing to confuse aspects of Medicare and Medicaid.

The nominee also touched on FDA policy, indicating he would implement President Donald Trump’s chosen position on the abortion pill mifepristone — noting Trump has not yet taken one — and agreeing more should be done to reduce the drug supply chain’s reliance on China.

Medicare drug negotiations: Democrats sought assurances that the Trump administration would continue to implement former President Joe Biden’s Medicare drug price negotiations if he’s confirmed.

“I’ve spoken to President Trump about negotiations — he’s absolutely committed to negotiating lower drug prices,” Kennedy told Sen. John Hickenlooper (D-Colo.) on Thursday.

Kennedy said he would comply with the law, but one open question is whether the Trump administration will continue to defend the Inflation Reduction Act, which is being challenged in court.

CMS released a statement Wednesday calling prescription drug cost savings “a top priority” for the president, acknowledging the list of 15 drugs selected for the second cycle of the program unveiled on Jan. 17 before the government handover.

“As the second cycle begins under the Trump Administration, CMS is committed to incorporating lessons learned to date from the program and to considering opportunities to bring greater transparency in the Negotiation Program,” the statement said. “CMS intends to provide opportunities for stakeholders to provide specific ideas to improve the Negotiation Program, consistent with the goals of achieving greater value for beneficiaries and taxpayers and continuing to foster innovation.”

Bird flu vaccine: The health nominee committed to continuing research into all vaccine platforms for avian influenza in response to questioning from Sens. Patty Murray (D-Wash.) and Andy Kim (D-N.J.).

Diversity: Kennedy committed to finalizing the FDA’s diversity action plan guidance in response to questioning from Sen. Ben Ray Luján (D-N.M.) on Wednesday.

The draft guidance — which aims to boost enrollment of people from populations underrepresented in clinical research — was among FDA documents that appear to have been removed from an agency’s webpage in response to Trump’s executive order targeting federal diversity, equity and inclusion programs.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. What a year this week has been.

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

A message from Boehringer Ingelheim:

Over 35 million Americans are living with chronic kidney disease (CKD), and 9 out of 10 of them don't know it. Proper screening and early diagnosis of CKD can make a huge difference in people's lives in how we treat it and how much it will cost. Boehringer Ingelheim, along with public health advocates, is calling on policymakers to make CKD screening a national healthcare priority now. Let's find CKD.

In Congress

Elizabeth Warren speaks while other senators and photographers look on.

Sen. Elizabeth Warren confronted Robert F. Kennedy Jr. at his HELP hearing about the compensation he receives from pharma litigation. | Francis Chung/POLITICO

SENATORS PROBE ETHICS FORM — During both confirmation hearings this week, two Democrats pressed Kennedy on the windfall his ethics agreement seemingly permits if lawsuits he referred to a personal injury firm lead to a settlement with — or a decision against — a major drug company.

But Kennedy’s responses raised more questions than answers for those senators and ethics experts, Lauren reports.

The confusion stems from a line in his ethics agreement stating he’s “entitled to receive 10% of fees awarded in contingency fee cases referred to” Wisner Baum, the firm leading the litigation against Merck over its HPV vaccine Gardasil. The lawsuits claim Gardasil can cause severe side effects and that the company concealed the risks, which Merck denies.

The questions: Sen. Elizabeth Warren (D-Mass.) asked Kennedy during Wednesday’s Senate Finance Committee hearing if he would decline compensation from pharma litigation during his government service and for four years afterward.

Virginia Democrat Tim Kaine raised the Gardasil litigation during Thursday’s HELP hearing, asking Kennedy how people “who need to have confidence in federal vaccine programs trust you to be independent … when you stand to gain significant funding if lawsuits against vaccine manufacturers are successful?”

The responses: Kennedy told Warren he’d “certainly commit” to forgoing compensation while he’s secretary — seemingly contradicting his ethics statement — then suggested she was asking him not to sue drug companies while serving.

He was more direct with Kaine, declaring he has “given away all of my rights to any fees in that lawsuit.” Kennedy spokesperson Katie Miller said the nominee “personally isn’t retaining the fees” linked to the Gardasil lawsuits.

More questions: In his agreement, Kennedy pledged to divest his interest in payments from Wisner Baum involving claims against the U.S., including cases filed at the federal vaccine court.

But he also said he would “irrevocably assign my right to receive payment in all contingency fee cases in which the United States is a party or has a direct and substantial interest to a non-dependent, adult family member” before taking office.

But the form also states that Kennedy will maintain a financial interest in cases that the HHS ethics office determines don’t involve the federal government as either a party or as having “a direct and substantial interest.” The U.S. isn’t a defendant in the Gardasil lawsuits.

The language in the agreement pertaining to Kennedy’s business relationship with Wisner Baum “is clear as mud,” said Kathleen Clark, a law professor and ethics expert at Washington University in St. Louis.

Miller didn’t respond to additional questions about the ethics agreement.

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Eye on the FDA

OPIOID ALTERNATIVE APPROVAL — On Thursday, the FDA approved Vertex Pharmaceuticals’ nonopioid pain reliever to treat moderate-to-severe acute pain, bringing a novel analgesic to market as the U.S. continues to grapple with an opioid epidemic.

The company said it has set a wholesale acquisition cost for the drug, called Journavx, at $15.50 per 50 mg pill.

WARNING ISSUED — A letter released this week shows that the FDA issued a warning last month to an outsourcing facility making compounded versions of popular GLP-1 medications to treat diabetes and obesity, among other products.

The Dec. 20 warning letter to ProRx, a so-called 503B facility that can produce compounded semaglutide at scale, outlined several apparent violations of federal drug law and corrective actions that “appear deficient.”

Products “intended or expected to be sterile were prepared, packed, or held under insanitary conditions,” risking contamination that could hurt patients, the FDA said. Agency investigators also recorded violations of current good-manufacturing processes at the ProRx facility, according to the letter.

The company was FDA-registered to make compounded semaglutide as recently as the second half of 2023, according to an agency database.

A message from Boehringer Ingelheim:

In Congress

GETTING INVOLVED — A trade association of 340B hospitals asked a federal court to allow them to help defend against a Johnson and Johnson lawsuit against the government over rebating in the 340B drug discount program.

The group, 340B Health, argues the government has the authority to block rebate schemes in the program.

“If the court permits J&J and other drug companies to replace upfront 340B discounts with backend rebates, it would cause crippling damage to safety-net hospitals throughout the nation,” 340B Health CEO Maureen Testoni said in a statement.

A J&J spokesperson said in an email that the matter is a “legal issue limited to our company and [the Health Resources and Services Administration].”

“J&J continues to take action to bring much-needed transparency essential to helping the 340B program achieve its original intent to support prescription drug access for vulnerable patients,” the J&J spokesperson said.

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WHAT WE'RE READING

STAT News’ Katie Palmer examines the different standards for advertising by pharmaceutical manufacturers and compounders, examining a Super Bowl commercial from Hims unveiled earlier this week.

Takeda CEO Christophe Weber is set to retire next year, BioPharma Dive’s Kristin Jensen reports.

A message from Boehringer Ingelheim:

Over 35 million Americans are living with chronic kidney disease (CKD), and 9 out of 10 of them don't know it. And as it stands now, very few of them will receive the two screening tests needed for CKD. The impact of this is huge: proper screening and diagnosis are one way to help individuals take charge of their health and minimize the financial burden on the healthcare system. For reference, Medicare spent $96 billion on individuals with chronic kidney disease (CKD) — over 25% of total Medicare fee-for-service expenditures — and another $28 billion on end stage kidney disease, in 2022. Boehringer Ingelheim, along with public health advocates, is calling on policymakers to make CKD screening a national healthcare priority now. Let's find CKD.