Bloomberg Government subscribers get the stories like this first. Act now and gain unlimited access to everything you need to know. Learn more.
The Department of Health and Human Services would get $119.8 billion in fiscal 2022 discretionary funding, a $22.9 billion increase from fiscal 2021.
The $253.8 billion bill is scheduled to be marked up today by the House Appropriations Labor-HHS-Education Subcommittee.
The measure would end long-standing prohibition on federal funds for syringes for safe drug use programs. The Hyde and Weldon amendments, which have banned federal funds for most abortion services, would be eliminated. The bill includes new provision that would limit funds to foster care programs that don’t comply with nondiscrimination regulations including gender identity and sexual orientation.
The National Institutes of Health would get $49 billion, a $6.5 billion increase from fiscal 2021. The agency’s funding includes $3 billion for President Joe Biden’s proposed biomedical research body, the Advanced Research Projects Agency for Health (ARPA-H). The Centers for Disease Control and Prevention tapped for $10.6 billion in fiscal 2022, a $2.7 billion increase.
Also Happening on the Hill:
- Drug Market Competition: The Senate Judiciary Subcommittee on Competition Policy, Antitrust, and Consumer Rights plans a hearing tomorrow on anticompetitive conduct in prescription drug markets.
- Covid-19 & Future Diseases: The House Science, Space, and Technology Investigations and Oversight Subcommittee will meet Wednesday to discuss principles for outbreak investigation.
Biden’s Big Order Seeks to Cut Drug Prices
Biden’s sweeping executive order signed Friday to strengthen competition includes 72 initiatives by over a dozen federal agencies, including the Health and Human Services Department. While there’s a long way to go from a directive to final regulations, Biden’s order seeks to tackle the sharp increase in consolidation of health-care companies in recent decades.
The order targets areas where it says the lack of competition increases prices and reduces access to quality care, starting with prescription drug prices. Biden’s order calls on federal health officials to work with states to create plans to import medicines from Canada, where they are cheaper. That, in some ways, echoes policies that former President Donald Trump pitched a year ago, but Canada balked at the proposal to let Americans import medicines.
Biden has directed the Department of Health and Human Services to issue a comprehensive plan within 45 days to counter high drug prices. That could bring back proposals by Trump and some Democrats to benchmark drugs to the cheaper prices paid in countries with national health systems. But it’s a move that drugmakers said would stifle innovation.
Biden will also urge the FTC to stop pharmaceutical manufacturers from paying their generic counterparts to delay entry into the market of lower-priced versions of medications. That idea is part of pending legislation in the Senate, and it aligns with campaign promises Biden made last year. Justin Sink and David McLaughlin have more.
Order Revisits Trump Answers on Drug Prices: Biden‘s order resurrects Trump administration policy plays geared toward cutting down drug prices, calling for efforts that policy analysts say may face challenges getting off the ground. The order includes measures to bolster health-care industry competition in the interest of lowering drug prices.
Roadblocks remain for both efforts to get off the ground, analysts say. For Canadian drug imports, legal experts say a lack of buy-in from Big Pharma and Canadian leaders could derail the efforts. Meanwhile, the FTC hasn’t made much practical progress in the area of “pay-for-delay” settlements despite making the area a priority for focus. Read more from Jacquie Lee and Ian Lopez.
Meanwhile, the order nudges regulators to update their guidelines for reviewing hospital mergers, but in many parts of the country, markets for health-care services and medical insurance are already highly concentrated. Drugmakers’ power to set prices is often based on natural monopolies from patents on medications.
Across the the health-care industry, potent lobbying groups are adept at harnessing political support to their advantage. Hospital trade groups pointed to their industry’s performance during the coronavirus crisis and said stricter antitrust regulation could threaten access in rural areas. Read more from David McLaughlin and Justin Sink.
Business groups in Washington quickly criticized the order.
- The Association for Accessible Medicine, the leading industry group for the generic drug industry, said it’s looking forward to working with the Biden administration to increase adoption of lower-cost generics and biosimilars “and remedy the growing number of government and payer policies that perversely reward the use of high-cost brands” over generics and biosimilars.
- But health-care interests that could face tighter antitrust scrutiny pushed back on the order and asserted that it could block patients’ from needed care. “Miring hospitals in legal and bureaucratic red tape will simply slow critical care to the bedside,” said Chip Kahn, CEO of the for-profit hospital trade group Federation of American Hospitals.
- The Biotechnology Innovation Organization said it’s evaluating the order, but urged Biden to focus on lowering out-of-pocket costs influenced by other companies along the supply chain. “That price is set by PBMs, insurers and the government, not by biopharmaceutical companies,” BIO policy chief John Murphy said.
- Steve Ubl, CEO of the Pharmaceutical Research and Manufacturers of America, said the U.S. already had “the world’s most competitive market for prescription medicines” in a statement that cited falling net prices and high rates of generic uptake.
The Coronavirus Pandemic
Fauci Criticizes Partisan Gap on Vaccination Lag: Anthony Fauci, the top U.S. infectious disease specialist, said “ideological rigidity” is preventing people from getting Covid-19 shots and voiced frustration at the struggle to boost vaccination rates in parts of the country. “It’s not an easy solution,” Fauci said on ABC’s “This Week” yesterday. “We’ve got to get away from this divisiveness that has really been a problem right from the very beginning with this outbreak.” With vaccination rates lagging mostly in southern and Midwestern states, Fauci made the rounds of U.S. morning talk shows to reinforce the Biden administration’s message that Covid-19 shots are safe and offer strong protection against the delta variant that’s now dominant in the U.S. Read more from Yueqi Yang.
- Missouri’s delta outbreak has raised alarms nationally as the U.S. races to contain the variant, which is more transmissible than the original strain that ground the world to a halt and killed millions. Rochelle Walensky, director of the Centers for Disease Control and Prevention, last week singled out southwestern Missouri as one of several hot-spots for the variant. Read more from Josh Wingrove.
- Coronavirus infections are rising across most areas of the world as delta spreads, clear evidence the pandemic isn’t on the decline, said the World Health Organization’s chief scientist. While vaccination levels in some countries are reducing severe cases and hospitalizations, large parts of the world face oxygen shortages, a lack of hospital beds, and high mortality, the WHO’s Soumya Swaminathan told Bloomberg TV. Read more from Corinne Gretler and Francine Lacqua.
- Related: G-20 to Warn of Virus Risks Amid ‘Great Divergences’ in Recovery
Schools Get CDC’s Leeway on Virus Limits: The CDC gave schools more flexibility to decide how to safely keep K-12 kids in while guarding against Covid-19. With the delta strain dominant in the U.S., there are fears about a potential surge in under-vaccinated areas, including for school children. But regions with high inoculation rates and low infections may elect to choose lesser levels of protection, said Erin Sauber-Schatz, who leads the CDC’s Community Intervention and Critical Population Task Force.
The CDC’s updated guidance, published Friday, continues to highlight distancing where possible, screening, mask use, ventilation and hand-washing. The new part: If localities decide not to use these strategies based on local conditions, they should be stopped one at a time, the guidance suggests, with ongoing monitoring for any rise in cases. “We have learned a lot in the last school year about what works,” Sauber-Schatz said. Read more from Fiona Rutherford.
- Hospital’s Vaccine Mandates Show Success in Boosting U.S. Uptake
- Mexico Creates Oasis of Vaccines in Bid to Reopen Border With U.S.
- Summers Says Preparing for Pandemics Like Buying Amazon Early
- Chinese Vaccine Makers to Supply Doses to Global Covax Program
- As U.K. Government Prepares to Scrap Rules, Covid-19 Cases Surge
- Russia Raises Covid-19 Death Toll for May by 65% as Crisis Worsens
- Germany Declares Spain a Risky Area After Surge in Covid-19 Cases
- France Backtracks on Pandemic Warning About Spain and Portugal
- Indonesia Extends Pandemic Curbs, Eyes Booster Shots for Doctors
What Else to Know Today
Court Leaves Fight Over Medicaid Work Rules in Limbo: Chief Justice John Roberts closed the latest Supreme Court term earlier this month with the fight over work requirements for Medicaid beneficiaries unresolved. Trump administration approvals of programs in Arkansas and New Hampshire requiring all Medicaid beneficiaries to work or participate in job-skills training to remain eligible for the health-care coverage sparked the dispute. The justices put the case on hold in April after the Biden administration announced the Centers for Medicare & Medicaid Services was withdrawing the prior administration’s approvals.
The case is now on life support and likely won’t be fully put to bed until early next term, some health law scholars say. The delay gives Arkansas time to pursue its administrative appeal of the Biden administration’s decision to withdraw the prior approval even though it’s unlikely the state will prevail. Read more from Lydia Wheeler.
Biden Aims to Reduce Detention of Pregnant Women: The White House is directing immigration enforcement officials to avoid detaining pregnant people—the latest step in its efforts to revamp how the U.S. treats immigrants. Under the policy, Immigration and Customs Enforcement officials should detain, arrest, or take into custody people who are pregnant, nursing, and postpartum only in “exceptional circumstances,” according to a congressional notice. Read more from Ellen M. Gilmer.
FDA Head Seeks Probe Into Biogen Drug Approval: The head of the FDA said she is seeking a federal investigation of the the approval of the Biogen Alzheimer’s disease drug Aduhelm, a highly unusual step that will bolster scrutiny of a heavily criticized clearance. In a letter, acting FDA chief Janet Woodcock said she wants an independent review of interactions between Biogen and FDA staff to see if any interactions were inconsistent with FDA policy. Robert Langreth has more.
- Philip Morris Vies With Carlyle to Buy Asthma Drugmaker Vectura
- Zantac Generic Drugmakers Out of Consolidated Cancer Lawsuits
- FDA Issues EUA for Ortho-Clinical’s Vitros Immunodiagnostic Test
- Sigilon Sinks Record as FDA Halts SIG-001 Study on Adverse Event
- FDA Approves Bayer’s Kerenda for Kidney Disease From Diabetes
To contact the reporter on this story: Brandon Lee in Washington at firstname.lastname@example.org