A warning from drugmakers

By David Lim, Katherine Ellen Foley and Lauren Gardner

Gilead is accused of delaying the development of an antiretroviral drug for HIV. | Josh Edelson/AFP via Getty Images

PHARMA FRETS OVER HIV DRUG LAWSUIT — The drug industry and its business allies warn that the outcome of a California lawsuit targeting a type of HIV medication could have a ripple effect on how companies across sectors innovate when developing medicines.

Their worries come as some of those same groups — PhRMA and the U.S. Chamber of Commerce — are hitting back against the Biden administration’s Medicare drug price negotiation program, making similar arguments about hampered innovation and research.

The lawsuit represents 24,000 HIV patients who claim drugmaker Gilead delayed the development of antiretroviral drug TAF to maximize profits while a similar company compound, TDF, maintained market exclusivity. The company pursued FDA approval of TAF so it could shift patients over to the new drug as TDF patents expired, the plaintiffs claim, a practice known as product hopping.

Side effects at issue: TDF drugs can cause bone-density loss and kidney disease — including organ failure — in a small percentage of patients. TAF’s side effects include higher cholesterol and weight gain.

The plaintiffs say TAF is a safer alternative for many patients — and that Gilead knew enough about those potential improvements in the early 2000s to pursue development then instead of waiting.

Gilead says it didn’t have enough clinical data at the time to know whether TAF would be safer or more effective than TDF, noting that TDF drugs like Truvada are FDA-approved to treat HIV.

Friends go to court: The U.S. Chamber of Commerce and the domestic auto industry argued in a friend-of-the-court brief that a decision finding manufacturers have a duty to prevent injuries from products that aren’t considered defective could create “a boundless standard of manufacturer liability” for not quickly developing the “safest” product.

The plaintiffs’ attorneys wrote in a brief that the lawsuit is actually a negligence case focused on actions “not in the laboratory but in the boardroom.”

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Settle a debate for us: How early is too early for holiday music?

Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM), David Lim (dlim@politico.com or @davidalim) and Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with David, who explains why patient advocates and the pharma industry have concerns about potential conflicts of interest from some speakers at CMS’ ongoing public listening sessions on Medicare drug price negotiations.

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As CMS holds patient listening sessions on Medicare price negotiations for drugs, such as Entresto, patient advocacy groups say some speakers have undisclosed ties to the pharmaceutical industry. | Scott Olson/Getty Images

WHAT CONFLICT OF INTEREST? The first four patient listening sessions for drugs selected for first Medicare price negotiations are in the books — and drug pricing advocates are worried a lax conflict of interest disclosure policy is allowing several speakers to not disclose ties to the pharmaceutical industry.

Drug manufacturers, lighting the negotiations on several fronts, are in a high stakes battle with the Biden administration that could result in millions in lower revenues and that the industry claims will stifle innovation for new drugs.

“Pharma tried to hijack the first meeting with its paid front groups,” said David Mitchell, president and founder of advocacy group Patients for Affordable Drugs.

One speaker at the Eliquis, Enbrel and Entresto sessions identified as a representative of a patient advocacy organization without a disclosed conflict of interest was Elizabeth Helms — founder and director of advocacy group Chronic Care Policy Alliance.

Since 2021, the group has spent more than $1 million lobbying Congress on legislation, including the Inflation Reduction Act. Helms is a registered lobbyist for the group and received $101,000 in related compensation during fiscal years 2020 and 2021, according to financial disclosure documents.

PhRMA’s perspective: The trade group that represents brand-name drugmakers believes the same could be said about advocacy groups hoping to influence CMS negotiation tactics with patient input. For instance, the group points to speakers affiliated with Doctors Without Borders, which receives funding from the Laura and John Arnold Foundation, which is critical of the pharmaceutical industry.

What’s next: Meena Seshamani, CMS deputy administrator and director of the Center for Medicare, hinted that the agency might change its policy of not requiring disclosure of financial conflicts of interest in the future. CMS declined to say why disclosures weren’t mandated now but said rules for the first year of negotiations are finalized.

A message from Coalition for Affordable Prescription Drugs:

A new survey shows 97% of employers who contract directly for pharmacy benefit services are satisfied with their PBM. And 86% of employers say it is important to have a range of options in how they pay PBMs for their services and expertise. Read the survey results.

YOUTH VAPING DECREASES — About 2.1 million youth used e-cigarettes regularly in 2023, representing a decline of about 500,000 from last year, according to a new survey from the CDC and the FDA.

Though e-cigarettes remain the most popular tobacco product among youth, tobacco usage in general decreased. In 2023, 2.8 million students from grades 6 to 12 reported using a tobacco product in the past 30 days compared with more than 3 million in 2022. However, the survey showed a slight uptick in tobacco usage among middle-school students.

Flavored vapes continue to hook teens. More than 46 percent of teens who tried an e-cigarette continued to use them, and flavored vapes remain the most popular among youth. When asked to select brands of e-cigarette products they use, students most often chose Elf Bar, Esco Bar, Vuse, Juul and Mr. Fog.

Most vapes on the market are illegal because they don’t have FDA authorization. Manufacturers of authorized vapes want to see stronger enforcement from the agency. Reynolds and Juul said they were happy to see declines in overall youth use of their products. But “the data further show the need to escalate enforcement against the illicit disposable products that now dominate youth use,” Joe Murillo, Juul’s chief regulatory officer, said in a statement to Prescription Pulse.

“We call on [the] FDA, in conjunction with state and local authorities, to strongly enforce against these and other illegal disposable products,” Luis Pinto, a spokesperson for R.J. Reynolds, said.

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WYDEN, CRAPO DROP PBM DISCUSSION DRAFT — Bipartisan leaders of the Senate Finance Committee Thursday released draft legislation that includes several policies that target pharmacy benefit managers. It includes provisions that would:

— Make Medicare Part D plans offer a high-discount biosimilar on their formulary starting in 2026

— Protect older adults from high cost-sharing for certain medicines starting in 2028 by tying enrollees to some cost-sharing after their deductible phase to the net price instead of the list price

— Ensure that those on Medicare have access to pharmacies. Starting in 2028, HHS would be able to designate pharmacies in underserved areas unaffiliated with PBMs or plan providers as essential retail pharmacies — a percentage of which preferred pharmacy networks must contract with.

Committee Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) are targeting a Nov. 8 markup.

A message from Coalition for Affordable Prescription Drugs:

Moderna anticipates 2024 will mark a “low point” for sales as the company adjusts to a post-pandemic business environment, Endpoints News’ Nicole DeFeudis reports.

The FDA published final guidance on its enforcement policies for electronic thermometers used in health care settings.

CMS released its CY 2024 Physician Fee Schedule final rule. It also released a final rule outlining its actions to remedy Medicare payment rates for drugs acquired by the 340B Program from CY 2018 to Sept. 27, 2022, in light of the Supreme Court’s ruling in American Hospital Association v. Becerra.

A message from Coalition for Affordable Prescription Drugs:

New polling shows that employers want options to choose the type of coverage that meets the unique needs of their employees. 89% of employers say their PBM is valuable in helping their organization offer affordable benefits to employees – and 91% of employers say it is important to have flexibility and choice in how their organization uses rebate savings. Read the survey results.

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David Lim @davidalim Lauren Gardner @Gardner_LM Katherine Ellen Foley @katherineefoley

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