HEALTH CARE BRIEFING: Democrats Prep Shift on Drug Pricing Push
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Democratic leaders say they’re eyeing a less aggressive drug pricing proposal in their broad tax and social spending package, which may offer some relief to drugmakers concerned about the original plan.
Speaker Nancy Pelosi (D-Calif.) told California’s KQED Wednesday she doesn’t expect her own signature drug pricing legislation (H.R. 3) to be included in a sweeping domestic spending package being developed by lawmakers.
Her proposal would subject hundreds of medicines to government negotiations and impose a heavy tax on drugmakers who refuse to reduce their prices overseas. “We’ll get something of that, but it won’t be the complete package that many of us having been fighting for a long time,” Pelosi said, in remarks that show how members of her own party have successfully pushed to water down the drug agenda.
Much remains unknown about what kind of drug pricing legislation Democrats can rally behind, or how much it would generate to offset the cost of other provisions in the package that would move via budget reconciliation, which could be passed by the Senate without any Republican support.
Three moderate Democrats were able to block a drug pricing proposal from advancing through the House Energy and Commerce Committee last month when it considered its slice of the budget reconciliation measure (H.R. 5376), although the proposal was approved by the Ways and Means Committee. Read more from Alex Ruoff.
Bills to Avoid ‘Telehealth Cliff’ Delayed by Higher Priorities: Lawmakers are struggling to push widely supported legislation that would end the “telehealth cliff” through a logjam created by their intense focus on more divisive priorities—such as the Democratic spending package, bipartisan infrastructure bill, addressing the debt ceiling and funding the government. “There’s not much oxygen in the room, even for an issue of agreement,” said Kyle Zebley, vice president of public policy for the American Telemedicine Association. Read more from Allie Reed.
Happening on the Hill
Warren, Grassley Repeat Call for FDA Hearing Aid Rule: Sens. Warren and Chuck Grassley (R-Iowa) repeated calls for the U.S. Food and Drug Administration to advance regulations for over-the-counter hearing aids. The senators sent a letter to acting FDA Commissioner Janet Woodcock urging the agency to issue its proposed rule by Nov. 6, in accordance with Biden’s executive order to promote competition, Daniela Sirtori-Cortina reports.
Senators Press State on ‘Havana Syndrome’ Reports: A bipartisan group of senators pressed Secretary of State Antony Blinken to name a point person to lead an investigation into reports about “Havana Syndrome,” a mysterious phenomenon causing diplomats and other U.S. officials to get sick at some overseas posts. The senators “remain concerned that the State Department is not treating this crisis with the requisite senior-level attention that it requires,” they said in a letter. Read more from Daniel Flatley.
Non-Compliant ACA Plans Get Watchdog Request: House Education and Labor Chair Bobby Scott (D-Va.) and Rep. Mark DeSaulnier (D-Calif.) have requested the Government Accountability office to assess certain health insurance products that are not subject to federal or state regulation, such as plans from state farm bureaus, health care sharing ministries, and others, according to an emailed statement from the panel. The lawmakers are interested in how such plans operate and impact the Affordable Care Act marketplace.
- More from GAO: Covid-19 Contracting: Indian Health Service Used Flexibilities to Meet Increased Medical Supply Needs
The Coronavirus Pandemic
White House Meetings Today on Vaccination Rule: OSHA’s proposed Covid-19 vaccination and testing emergency temporary standard will be the focus of upcoming meetings between the White House, pro-business groups, and worker advocacy organizations. The Office of Information and Regulatory Affairs is set to launch meetings today.
Among the groups saying they are set to meet with the regulatory affairs office are the U.S. Chamber of Commerce, the Retail Industry Leaders Association, and the National Association of Manufacturers. Others groups saying they’ve made requests and are waiting appointment dates are the AFL-CIO labor federation and the National Restaurant Association. Read more from Bruce Rolfsen.
- Biden said yesterday the number of unvaccinated Americans remains too high and he called on more businesses to impose mandates even as the number of Covid-19 cases declines. “We have to do more to vaccinate,” Biden said at the White House. “Every day, we see more businesses implementing vaccination requirements and the mounting data shows that they work.” He added: “I’m calling on more businesses to step up.” Read more from Josh Wingrove and Jennifer Jacobs.
- Meanwhile, Labor Secretary Marty Walsh is trying to preempt criticism of an impending private-sector vaccine mandate with a simple message: This is about employment growth, not burdens. “The intention is not to put a burden on businesses; the intention is to get people vaccinated” Walsh said in an exclusive interview that was part of Bloomberg Government’s Hill Watch event yesterday. Read more from Ben Penn.
- Video: Biden’s Vaccine Mandate and the Likely Legal Challenges
- Judges in NYC Vaccine Mandate Case Skeptical of Teachers’ Claims
- Chicago Mayor Stands by Vaccine Order Amid Police Union Standoff
- Texas Boasts of Vaccine Mandate Victory Over San Antonio
U.S. Shifting Pandemic Tracking Back to CDC: The Biden administration is moving the U.S. government’s largest public-health tracking system back to the Centers for Disease Control and Prevention, undoing a much-criticized move by the Trump administration to shift custody of critical data from the nation’s top epidemiological agency. According to a document obtained by Bloomberg News, HHS on Oct. 1 signed off on a recommendation to move the system, designed to track pandemic data, out of the management of its own Office of the Chief Information Officer and into CDC’s oversight. Read more from Riley Griffin.
FDA Panel Meets Again Today After Backing Moderna Booster for Some: The FDA advisory panel is evaluating Johnson & Johnson’s booster today after yesterday recommending that booster shots of Moderna’s Covid-19 vaccine should be given to older people and those at high risk of the disease. The additional doses should be offered to people aged 65 and older along with those between 18 and 64 years old who are at high risk for medical or occupational reasons, the Food and Drug Administration advisory panel said yesterday in a unanimous, 19-0 vote. The shots should be given six months after the initial inoculation, the panel said. Read more from Robert Langreth.
- The vaccine experts had earlier debated which workers are truly at higher risk of severe Covid-19 because of their jobs. Fiona Rutherford has more.
- Separately, the FDA is sending Merck’s Covid-19 pill to an advisory committee for review, using a public forum to discuss any safety concerns ahead of a potential authorization. The FDA announced the hearing for Nov. 30, saying it would weigh data on the use of the drug, molnupiravir, to treat mild-to-moderate cases in high-risk adults. It’s the first potential therapeutic treatment for Covid-19 that the agency referred to an advisory panel, the FDA said. Read more from Josh Wingrove.
Biden to Donate More Shots to Africa: Biden will announce the donation of an additional 17 million doses of Johnson & Johnson’s coronavirus vaccine to the African Union after the U.S. faced criticism it hasn’t been more generous. Biden was expected to make the announcement at a meeting yesterday with Kenyan President Uhuru Kenyatta at the White House, according to a senior administration official who requested anonymity ahead of the event. Read more from Justin Sink.
- Six out of seven Covid-19 infections go undetected in Africa, showing that the impact of the disease on the world’s least vaccinated continent is likely underestimated, according to the World Health Organization. By Oct. 10 only 70 million tests had been carried out in Africa, compared with 550 million in the U.S., WHO said. Read more from Antony Sguazzin.
- The U.S.’s top trade official said there’s been progress in World Trade Organization negotiations aimed at waiving intellectual-property protections for vaccine production, but the challenge is getting all 164 WTO members on board. “While we are making progress, collectively, there is still a lot more progress that we need to make,” U.S. Trade Representative Katherine Tai said yesterday during an event in Geneva. Read more from Bryce Baschuk.
- Related: IMF Chief Says World Has Enough Doses for Unvaccinated, Boosters
- Regeneron Says FDA Accepts Regen-Cov BLA for Priority Review
- Illinois Nursing Facility Faces $83,000 Fine Over Covid-19 Hazards
What Else to Know
Former Obama FDA Chief Califf Is Top Contender: Robert Califf, who ran the FDA under President Barack Obama, has moved into top contention to lead the agency again, people familiar with the matter said. While a decision isn’t final, Califf is now the front-runner, said the people, who asked not to be identified because nothing has been announced. He’s currently head of strategy and policy at Alphabet. Read more from Josh Wingrove and Nancy Cook.
J&J Forms Unit to Hold Talc Claims: Johnson & Johnson said it formed a new unit called LTL Management to hold and manage claims in the cosmetic talc litigation, with the unit filing for voluntary Chapter 11 bankruptcy protection. To provide funding to LTL for the payment of amounts the Bankruptcy Court determines are owed by LTL. It will also establish a $2 billion trust to that end. Greg Chang has more.
Childhood Cancer, Epilepsy Studies Get FDA Grants: The Food and Drug Administration yesterday awarded more than $25 million in grants to clinical trials investigating potential treatments for pediatric brain cancers, epilepsy, and several other conditions as part of the agency’s rare diseases research program. Read more from Celine Castronuovo.
Drug Impurity Woes Worsen with Lupin Recall: A unit of Indian drugmaker, Lupin, issued a voluntary U.S.-wide recall for some batches of two blood pressure pills over concerns about potentially carcinogenic impurities. Lupin Pharmaceuticals issued a recall for Irbesartan tablets and Irbesartan and Hydrochlorothiazide tablets after its analysis revealed that some batches of these drugs had more than permitted levels of N-nitrosoirbesartan, a probable carcinogen, the company said in a statement to exchanges. Read more from Rahul Satija.
Texas City’s Abortion Ban Upheld: A Texas city’s abortion ordinance that mimics a highly restrictive state law by putting enforcement power in private hands will remain in place, because even a win for the abortion provider wouldn’t stop other lawsuits against it, a federal court said. The suit challenging the Lubbock ordinance mirrors cases in which abortion providers are fighting a state law that prohibits abortions after six weeks. Read more from Mary Anne Pazanowski.
- Texas Lawyer Behind Abortion Ban Says Copycat Fears Overblown
- Abortion Providers Ask State Court to Strike Medicaid Pay Ban
More From the Courts:
- Generic Drug Maker Teligent Files Bankruptcy, Plans Sale
- Home Health-Care Fraudulent Billing Lawsuit Rejected on Appeal
- Aetna to Face Lawsuit Over Proton-Beam Cancer-Care Coverage
- Northwestern Medicine Hit With Proposed Data Breach Class Action
- Mallinckrodt’s Bankruptcy Plan Faces Justice Dept.’s Opposition
- Doctor Off Hook for Patient’s Suicide After Ketamine Treatments
- Holmes Hired Dermatologist at Theranos When Going Got Rough
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