HEALTH CARE BRIEFING: Warren Bid on Cancer Drug Patents Rebuked

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An effort by Sen. Elizabeth Warren (D-Mass.), other lawmakers, and advocacy groups to force the government to green-light production of a cancer drug by third-party manufacturers is meeting stiff opposition from nearly 100 interest groups and individuals.

President Joe Biden’s Health and Human Services Department should flat-out reject a plea for the government to grant so-called “march-in rights” for patents on the prostate cancer drug Xtandi, the Bayh-Dole Coalition and other individuals and interest groups said in a letter to HHS Secretary Xavier Becerra. Similar requests for march-in rights were rejected several times during the Obama administration, according to the letter.

A trustee of the Dana-Farber Cancer Institute and others petitioners have asked the HHS to license Xtandi patents for outside companies to produce copycats of the drug in attempt to lower prices, an effort that gained the support of Warren, along with Sen. Angus King (I-Maine) and Rep. Lloyd Doggett (D-Texas).

The Bayh-Dole Act’s march-in rights allow the government to license a private company’s patents to outside entities if the government helped funding the invention’s research and development.

But the law is “not a magic panacea to suddenly lower drug prices,” said Joe Allen, the Bayh-Dole Coalition’s executive director and a former Senate Judiciary Committee staff member during passage of the law, in an interview. The Bayh-Dole coalition is a organization composed of drug industry groups, university entities, and other organizations.

Medivation, acquired by Pfizer, was joined in developing the drug by Astellas. Astellas is considered the drug’s owner.

Citing findings from Knowledge Ecology International, Warren’s February letter to the HHS said that Xtandi’s average U.S. wholesale price was $130 while a 40mg capsule in Japan was priced a little over $20. Read more from Ian Lopez.

The Coronavirus Pandemic

Health Worker Vaccine Mandate Stays Intact as Pandemic Recedes: The vaccine mandate for health-care workers will likely remain firm even as other cornerstones of Biden’s pandemic response dissolve with the administration’s messaging that the U.S. is in a new phase of the pandemic. The mandate requires health-care workers at facilities paid by Medicare and Medicaid to be fully vaccinated or they risk loss of funding. It was written at the peak of the delta variant surge. The Supreme Court ruled in favor of the Medicare agency’s mandate as the omicron variant ripped through the U.S. health-care system. Read more from Allie Reed.

U.S. Covid-19 Infections Likely to Rise Again, Fauci Says: A likely rise in U.S. Covid-19 cases probably won’t amount to a full-scale surge or prompt a renewal of widespread restrictions, one of Biden’s top advisers said. “The bottom line is we likely will see an uptick in cases, as we’ve seen in the European countries, particularly the U.K.,” Anthony Fauci, Biden’s chief medical adviser, said on ABC’s “This Week” on Sunday. “Hopefully we won’t see a surge. I don’t think we will.”

The BA.2 subvariant of omicron is driving up cases in Europe and Asia, notably in Hong Kong, and now accounts for about 30% of infections in the U.S, where indoor-mask and vaccine requirements have largely been rolled back. Read more from Ian Fisher.

mRNA Shots Blocked Worst Outcomes, CDC Says: mRNA vaccines were highly effective at preventing people from suffering the most severe outcomes from Covid-19 even as infectious new coronavirus variants spread, a U.S. study found. Receiving two or three doses of a vaccine made by either Moderna or partners Pfizer and BioNTech led to a 90% reduction in the risk of needing to be put on a ventilator or death due to Covid-19, according to a study published by the Centers for Disease Control and Prevention on Friday. Read more from Fiona Rutherford.

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What Else to Know Today

Experian, Equifax, TransUnion to Cut Most Medical Debt Reports: Experian, Equifax, and TransUnion said they will remove more than 70% of existing medical debt entries from credit reports, getting ahead of a review of the issue by federal regulators. Beginning July 1, the three consumer credit bureaus will remove all medical debt that had been repaid. They will stop reporting in-collection balances under $500 starting in 2023. The companies also will extend the time period before medical debt is added to a credit report from six months to one year, they said in a joint statement Friday. That would give consumers more time to repay debts before their credit reports are affected, they said. Read more from Evan Weinberger.

Biden praised the credit reporting firms for the move, Alisa Parenti reports. Biden said in a tweet it’s “a step in the right direction” thanks to pressure from the Consumer Financial Protection Bureau.

Russian IP Animus Fuels Risk, Uncertainty as Firms Recalibrate: Western entities trying to protect everything from drug patents to trademarks in Russia worry IP protection there may become unfeasible as instability increases over Moscow’s war in Ukraine. Russia’s response to sanctions was to say that intellectual property of companies from countries it deems unfriendly won’t get protected. As a result, Russia could become awash with counterfeits that also could be exported to other markets, attorneys say. Read more from Kyle Jahner.

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To contact the reporter on this story: Michaela Ross in Washington at mross@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Loren Duggan at lduggan@bgov.com

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