HEALTH CARE BRIEFING: Swift Passage Sought for Key Health Bills

Lawmakers are considering how to package and pass overlapping proposals on biomedical innovation and pandemic preparedness before a top senator’s retirement at the end of the year.

The good news is all proposals have bipartisan support. The bad news is Congress is already overloaded with other agenda items, such as Democrats’ social spending legislation, narrowing the time available for complex committee negotiations and floor votes. Advocates close to the discussions say one solution may be stitching all the proposals together. Parts of the agenda could also hitch a ride on must-pass legislation on FDA user fees.

Last week’s release of draft legislation on pandemic preparedness from Sens. Patty Murray (D-Wash.) and Richard Burr (R-N.C.) marks the latest—and most significant—effort to bolster medical research and public health in the wake of the ongoing Covid-19 crisis. The senators, who lead the Health, Education, Labor and Pensions Committee, said they’re considering additional provisions to their draft bill, the PREVENT Pandemics Act.

The effort dovetails with a similar House effort to expedite development of life-saving medicines known as Cures 2.0 (H.R. 6000). Also in the mix is authorization of the Advanced Research Projects Agency for Health, President Joe Biden’s proposal to set up a dedicated research agency that aims to speed up biomedical discoveries.

“There seems to be some core components, at least between current PREVENT Pandemics and Cures, that I think could really move,” said Alyssa Llamas, a director at the consulting firm Wynne Health Group. She said the three pieces could be in a single package to speed medical developments and prepare for novel disease outbreaks like Covid-19. Read more from Jeannie Baumann and Alex Ruoff.

Happening on the Hill

Biden Economic Agenda on Hold as More Americans Hit Hardships: American families are feeling the financial squeeze of soaring inflation and a persistent pandemic as fractious Democrats return to Washington this week no closer to a deal on a tax and spending bill party leaders hoped would by now provide relief. Read more from Mike Dorning and Erik Wasson.

Speaker Nancy Pelosi cast doubt on a drive by progressive Democrats to get some version of Biden’s agenda through Congress by March 1. “We don’t have a timetable,” Pelosi (D-Calif.) said during an appearance Friday in her hometown of San Francisco. “We will pass the bill when we have the votes to pass the bill.” Read more from Billy House.

The Coronavirus Pandemic

Covid-Infected HIV Patient Developed 21 Mutations, Study Shows: A South African woman suffering from inadequately treated HIV, and who harbored Covid-19 for nine months saw the respiratory virus develop at least 21 mutations while in her body, according to a study. The study adds to evidence that Covid-19 may mutate rapidly when harbored by immunosuppressed individuals, such as those not taking medication to treat HIV, and this may lead to the development of new variants. The beta variant, which the patient in the study was infected with, was discovered in South Africa, as was omicron. Read more from Antony Sguazzin.

Free Covid-19 Tests Ordered by 60 Million U.S. Households: About 60 million households in the U.S. have ordered at-home rapid Covid-19 tests from the federal government after Biden made them available for free to ease shortages fueled by the omicron variant. White House spokeswoman Karine Jean-Pierre announced the figure Friday. “Tens of millions” of test kits have been shipped out, she said. The administration has yet to say how many tests it has so far received for delivery to households, though many have begun arriving to homes around the country. Josh Wingrove has more.

Covid-19 Pill Dispensing Costs Push Pharmacies to Call on Medicare: High-risk Covid-19 patients could see reduced access to Pfizer and Merck’s antiviral pills without a federal mandate that insurers pay pharmacies for dispensing the medications, industry groups say. Pharmacy groups argue the Medicare agency should require minimum insurance payments for the tasks involved with distributing the at-home treatments, including conducting risk assessments and educating prescribers. Adequate payment is especially needed for smaller pharmacies, they say. Read more from Celine Castronuovo.

• Merck’s Covid-19 pill showed activity against omicron in six lab studies that raise confidence in the ability of the new therapy to battle the contagious variant. Independent studies from the U.S. and five European countries examined the impact of Merck’s molnupiravir and other antivirals against variants of concern including omicron, Merck and partner Ridgeback Biotherapeutics said Friday in a statement. Read more from John Lauerman.

More Headlines:

• Omicron Subvariant Spreads Faster, and Boosters Remain Effective
• Masks and Vaccines: Bar Exam Covid-19 Rules Are All Over the Map
• Trucker Vaccination Rule Worsens Supply Chain Woes, Kenney Says
• Spotify Adds Covid-19 Notices in Effort to Stop Rogan Boycotts

What Else to Know Today

Alabama’s Abortion Process for Minors Gets Hearing: Alabama’s procedure for minors who want to have abortions without telling their parents will get another outing at the Eleventh Circuit, as the court vacated a panel ruling holding it unconstitutional and granted full-court review. A three-judge panel said in an earlier ruling that modifications to the judicial bypass process put substantial obstacles in the way of minors seeking abortions. The new procedures unduly burden the right to abortion, the U.S. Court of Appeals for the Eleventh Circuit said. Mary Anne Pazanowski has more.

Combination Drug-Device Makers Get FDA Review: The FDA will review pre-filled syringes and other drug-device combination products based on which component achieves the primary purpose of the product, the agency said in guidance published Friday. The guidance document outlines which office of the Food and Drug Administration will review each product and seeks to provide clarity on how the agency intends to classify certain combination items. It also aims to shed light on what device makers will need to submit for premarket review, Celine Castronuovo reports.

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

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