HEALTH CARE BRIEFING: ARPA-H Faces Pressure on Drug Patent Grabs

The NIH could find itself wading into the drug pricing debate as it houses a new biomedical accelerator, despite its longstanding policy not to get involved in the cost of new therapies.

There’s been a push, particularly among progressives, for the NIH to exercise what’s known as “march-in rights” to temper drug prices, most recently on Astellas’ cancer drug Xtandi. Established under the 1980 Bayh-Dole Act, march-in allows the government to seize patents for inventions created with public funding and license them to other entities for commercialization. No federal agency has ever exercised its march-in rights, and the NIH has denied all march-in petitions.

The Advanced Research Projects Agency for Health (ARPA-H) will sit within the National Institutes of Health under a plan to get the new entity off the ground. That setup means NIH money will have a more direct hand in publicly-funded technologies that come to market—raising questions over whether the NIH should intervene in high prices.

The NIH has historically held the position that it can exercise march-in rights if a company were to license a product but never do anything with it—but not as a way to ease costs.

“As NIH is going to get more involved in late-stage drug development, with taxpayer funding, the risk that the taxpayer through NIH is assuming in the development of these products is much higher,” Ameet Sarpatwari, a faculty member at Harvard Medical School’s bioethics center, said in an interview.

But Tom Miller, senior fellow at the American Enterprise Institute, expressed skepticism that the political will exists to start using march-in rights given challenges to pass drug pricing legislation. Jeannie Baumann has more.

Happening on the Hill

Hearings This Week:

• The Senate Commerce, Science and Transportation Committee holds a Thursday hearing on drug pricing transparency. The committee plans to scrutinize pharmacy benefit managers and how “the lack of transparency about how they operate” have contributed to higher drug prices for consumers. Read a statement here.
• The Senate Foreign Relations Committee Wednesday will consider the nomination of John Nkengasong as ambassador-at-large and coordinator of U.S. Government Activities to Combat HIV/AIDS Globally. Nkengasong is currently the director of the Africa Centres for Disease Control and Prevention. Read a statement here.
• Stay up to date on all of the week’s hearings with BGOV’s Calendar and Events.

Democrats Question Meta Over Eating Disorder Content: Lawmakers are demanding answers from Meta Platforms CEO Mark Zuckerberg after new evidence emerged that his company is pushing eating disorder content on kids and teens. Meta, the parent of Facebook and Instagram, has repeatedly come under criticism for what lawmakers on both parties argue is a failure to protect young people online from targeted ads. Read more from Maria Curi.

The Coronavirus Pandemic

U.S. Seeks Data on Covid Relapses After Paxlovid: Federal government researchers are planning studies of how often and why coronavirus levels rebound in some Covid patients who have completed a five-day course of treatment with Pfizer’s Paxlovid. “It’s a priority,” said Clifford Lane, the deputy director for medical research at the National Institute of Allergy and Infectious Diseases, calling the issue “a pretty urgent thing for us to get a handle on.” The agency is discussing a slew of possible epidemiological and clinical studies to examine post-Paxlovid rebound with CDC scientists, Lane said. Robert Langreth and Madison Muller have more.

June FDA Review Eyed for Child Covid Vaccines: Outside advisers to the Food and Drug Administration tentatively plan to meet in June to discuss Covid-19 vaccines for younger kids. The FDA said on Friday that it has held the dates of June 8, June 21 and June 22 for potential meetings of its Vaccines and Related Biological Products Advisory Committee to discuss pediatric use of vaccines made by Moderna and Pfizer-BioNTech. The news comes a day after Moderna said it had applied for emergency authorization of its shot in young kids. Read more from Robert Langreth.

CDC Casts Doubt on Covid Causing Kids’ Liver Issues: U.S. health officials cast doubt on Covid-19 as a potential cause of severe hepatitis seen in dozens of previously healthy individuals across around the world, while adding weight to the possibility that it’s caused by a more common virus linked to stomach ailments. The Centers for Disease Control and Prevention on Friday released its most detailed report yet on nine cases of pediatric hepatitis in Alabama that have captured national attention. All the patients tested negative for Covid at the hospital and had no documented history of infection, it said. Madison Muller has more.

More Headlines:

• Biden Attends Correspondents’ Dinner as Virus Stalks D.C. Area
• Omicron Sublineages Evade Antibodies From Earlier Infections
• White House Communications Director Tests Positive for Covid

What Else to Know Today

Medicare Moves to Improve Equity in Plans: Beneficiaries in Medicare Advantage plans and Medicare Part D prescription drug plans can expect improved transparency and lower out-of-pocket costs for medications under a final rule issued on Friday by the Biden administration. The final rule provides a number of enhancements designed to improve access and advance health equity for people who qualify for both Medicare and Medicaid.

“The Biden-Harris Administration has remained committed to ensuring equity in health care for all,” said Chiquita Brooks-LaSure, head of the U.S. Centers for Medicare and Medicaid Services. “This rule improves the health care experience and affordability for millions of people with MA and Part D coverage, including dually eligible individuals, and provides needed support to populations often left behind.” Read more from Tony Pugh.

Purdue Locks Horns With DOJ Over Oxycontin Deal: A $6 billion deal hangs in the balance as OxyContin maker Purdue Pharma and its wealthy owners square off against the Department of Justice over the firm’s opioid lawsuit settlement. The sides will meet in a New York court Friday to argue over a plan to funnel billions of dollars to opioid crisis abatement efforts and settle trillions of dollars of legal claims against the drugmaker. Purdue got approval of the deal in bankruptcy court last year, but an appeals judge later threw out the accord in a shock decision. Read more from Jeremy Hill.

SCOTUS Ruling on Bias Remedies Goes Beyond Health Care: The U.S. Supreme Court’s decision on Thursday that federal anti-bias laws don’t allow plaintiffs to recover damages for emotional distress struck a blow to private enforcement of those laws by leaving litigants with no effective remedy, attorneys who practice in the area argue. And that verdict isn’t just about people with disabilities, Mary Crossley of the University of Pittsburgh Law School, said. Since the case involves “spending clause legislation,” similar analyses would apply to other federal anti-bias laws, she said. Read more from Mary Anne Pazanowski.

More Headlines:

• N.Y. Employers Appeal Order in Reproductive Health Bias Case
• Patient Left With Facial Paralysis Loses Effort to Revive Lawsuit
• Biocytogen Enters Into Antibody Agreement With Merck KGaA

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com