Pharma settles in criminal drug probe

From: POLITICO Pulse - Tuesday Aug 22,2023 02:02 pm

Aug 22, 2023

Driving the Day

Justice Department building

In a settlement with the Department of Justice, drugmakers Teva and Glenmark have agreed to sell off their operations that produce the cholesterol drug pravastatin. | Andrew Harnik/AP Photo

PHARMA GIANTS PAY MILLIONS — Two generic drug giants agreed Monday to settle long-running criminal price-fixing charges with the Justice Department, including the unusual move to sell off the drugs involved, POLITICO’s Josh Sisco reports.

The U.S. arms of Israel-based Teva and India-based Glenmark will pay $225 million and $30 million, respectively, according to court filings. The companies agreed to enter into deferred prosecution agreements, a resolution in which charges are suspended, but a company must admit wrongdoing. It can later face charges if it doesn’t follow the terms of the deal.

Teva will also donate $50 million in drugs to humanitarian organizations.

Inside the settlement: The two companies agreed to sell off their operations that make the cholesterol drug pravastatin.

Teva acknowledged fixing prices on pravastatin and clotrimazole, used for skin infections, and tobramycin, used to treat cystic fibrosis. Glenmark admitted to fixing pravastatin prices.

In a statement, Teva said the conduct involved a single employee between 2013 and 2015, and the company is pleased to resolve the case.

Glenmark said in a statement it had strengthened its compliance practices. “We will continue to conduct our business with the utmost transparency and integrity,” Sanjeev Krishan, president of Glenmark's U.S. business, said.

Background: The settlements resolve a criminal probe of the generic pharmaceutical industry dating to 2014. Five other companies, including Novartis-owned Sandoz, have entered into deferred prosecution agreements and paid $426 million in criminal fines. A senior sales executive from Taro Pharmaceuticals is fighting price-fixing charges stemming from the same investigation.

While Teva was the last and largest of the generic drugmakers to face charges, myriad companies face civil claims in a variety of class-action lawsuits and cases brought by nearly every state attorney general in the country.

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Medicare

Senior Diana Sieg (Right) is helped by volunteer Chris Vitalis as she signs up for the new Medicare drug prescription program.

Medicare plans a new, optional program that will let its beneficiaries pay for prescriptions monthly instead of in one lump sum. | Justin Sullivan/Getty Images

MEDICARE LAUNCHES MONTHLY PAY PLAN — CMS announced a new program Monday aimed at spreading out the costs older adults and people with disabilities will face at the pharmacy counter, POLITICO’s Robert King reports.

The agency released the first of two draft guidance documents introducing the voluntary Medicare Prescription Payment Plan set to start in 2025. It’s the latest effort by the Biden administration to rein in drug costs in Medicare and implement the Inflation Reduction Act.

A Medicare participant can opt into the program starting in 2025, and their out-of-pocket drug costs will be capped and spread out via monthly installments instead of one lump sum.

The initial guidance, open for comment for 30 days, lays out how Medicare Part D plans can set up the infrastructure for the program. The plans must still reimburse pharmacies for the full cost-sharing amount.

A second guidance document expected in early 2024 will offer information on how plans can modify their bids and on outreach and education of their members.

This program is part of a larger Part D redesign passed as part of the IRA. Earlier this year, CMS implemented a $35 monthly cap on insulin costs for beneficiaries, and the agency must announce the first drugs subject to price negotiation by Sept. 1.

What’s next: The agency will also implement a $2,000 out-of-pocket drug cost cap by 2025.

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Vaccines

BACKTRACK ON VACCINE LAG — Just days after warning that pharmacies wouldn’t provide free Covid vaccines to people without health insurance until October, the Biden administration and retail pharmacies are trying to accelerate the timeline, POLITICO’s Adam Cancryn and David Lim report.

Biden health officials are attempting to finalize contracts that would allow pharmacies like CVS and Walgreens to offer the shot to uninsured Americans as early as mid-September when the government plans to make an updated version of the vaccine available to the broader public.

That’s roughly a month earlier than initially planned, said two people familiar with the contract negotiations granted anonymity to discuss ongoing talks. It’s an abrupt shift that came amid reports from POLITICO and others that Americans without health coverage would need to wait to get their no-cost shot at a pharmacy until mid-October.

The timing gap prompted concerns from public health experts, who fear that it would further complicate the fall vaccination campaign and discourage uninsured people from getting the shot, even as Covid hospitalizations rise again.

Americans without health coverage can still get the new vaccines at no cost from community health centers and individual providers as soon as they are rolled out, ensuring immediate access at those locations.

Public Health

HEALTH MISINFO CONFUSES AMERICANS — At least 4 in 10 Americans say they’ve encountered specific health misinformation around vaccines, Covid-19, gun violence and birth control — and most say they weren’t sure whether it was true or false, according to a new KFF survey out this morning.

What they believe:

— A third of adults surveyed said the false claim that Covid causes thousands of sudden deaths in healthy people was “definitely” or “probably” true.

— A third of respondents said the false claim that birth control use made it harder to get pregnant after use was “definitely” or “probably” true.

— About 4 in 10 adults said the false claim that people who have firearms at home were less likely to be killed by a gun than those who didn’t own a gun was “definitely” or “probably” true.

What to watch: Ahead of a fall campaign to get people updated Covid shots, as well as respiratory syncytial disease and flu shots, the results are telling about what may be influencing consumer behaviors.

Where they get their news: People overwhelmingly said they trusted their own doctor’s recommendations — though a recent study found that doctors across medical disciplines participated in health misinformation during the pandemic. Two-thirds of the public also said they had a fair amount of trust in the CDC and FDA.

TV news is still among the most trusted for health information — and where it comes from matters: Less than half of respondents who say they’ve heard one of the false Covid vaccine claims believe it’s definitely or probably true, but that percentage ticked up for regular viewers of more conservative channels, including Newsmax and OANN.

Names in the News

Shauna Rust is now a senior policy adviser in the Office of the Administrator at HHS’ Health Resources and Services Administration. She previously was a professional staff member for Democrats on the Senate Veterans’ Affairs Committee.

Jeffrey A. Nesbit is joining HHS as assistant secretary for public affairs. He previously was the Social Security Administration’s deputy commissioner for communications.

Former Pennsylvania Republican congressman Ryan Costello has joined the Pharmaceutical Care Management Association.

What We're Reading

POLITICO's Lauren Gardner reports on the approval of maternal RSV vaccines.

The Washington Post reports on lingering long covid symptoms two years later.

The Wall Street Journal reports on the boom of products being marketed toward people with anxiety.

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