House Democrats later today plan to showcase how drugmaker AbbVie made a rheumatoid arthritis treatment into one of the most-profitable medications to make the case the federal government must be empowered to negotiate on the price of medicines.
The House Oversight and Reform Committee will host Richard Gonzalez, chief executive officer of AbbVie, and three researchers who study drug pricing in the U.S. AbbVie makes the blockbuster rheumatoid arthritis treatment Humira, which brought the company nearly $15 billion in net sales in 2019 alone.
“Our work has confirmed what patients in this country have known for a long time—drug prices in the United States are simply unfair, unsustainable, and just plain wrong,” panel Chair Carolyn Maloney (D-N.Y.) will say, according to prepared remarks for the hearing.
Oversight Democrats want to make AbbVie the poster child for abuses of the pharmaceutical industry and the reasons they need to pass their caucus’s signature drug-pricing legislation (H.R. 3).
The panel is investigating the drug-pricing practices of a dozen drugmakers and has threatened to subpoena AbbVie for documents related to how the company has priced Humira. AbbVie has raised the price of Humira repeatedly since it came to market in 2003, now at $2,984 a syringe, or $77,586 annually, according to the committee.
A senior Democratic committee aide told Bloomberg Government the panel’s investigation has found that AbbVie actively targeted the U.S. market for price increases, in part because the government doesn’t dictate what medicines cost. Democratic leaders on the committee plan to outline how H.R. 3 would have stymied those price increases, Alex Ruoff reports.
Happening on the Hill
Paid Leave Hearing: The Senate Health, Education, Labor and Pensions Committee scheduled a hearing to examine access to paid leave for working families.
House Floor: The House will consider several health-related bills under suspension of the rules, including:
- Medical Supply Chain: The president’s authority to use the Defense Production Act to bolster the supply chain for critical medical supplies would be clarified under H.R. 3146. For more, see the BGOV Bill Summary by Michael Smallberg.
- Production of Covid-19 Supplies: Covid-19 tests, personal protective equipment, and drugs could be designated as scarce and critical materials for use of the Defense Production Act under H.R. 3125. For more, see the BGOV Bill Summary by Michael Smallberg.
House Republican leaders signaled yesterday that there was no longer widespread opposition to the bill meant to stop drugmakers from extending their monopoly on orphan drugs, especially for those used to treat opioid use disorders. Rep. Tom Cole (R-Okla.), ranking member of the House Rules Committee, blamed Democrats for the delay in passage of the legislation (H.R. 1629), which was unable to pass last week under suspension of the rules, Alex Ruoff reports.
Rep. Buddy Carter (R-Ga.) led 167 of his colleagues against the measure last week to protest being removed as the bill’s co-lead. Rep. Madeleine Dean (D-Penn.) said she declined to make Carter her co-lead again after Carter was one of the 138 House Republicans to object to Pennsylvania’s Electoral College vote certification in January.
The bill, which would prevent drug makers from obtaining market exclusivity for certain drugs used to treat rare diseases, is slated to come to the House floor for a vote this week. Cole, who voted against the bill last week, said the bill “is certainly going to enjoy bipartisan support and hopefully we can avoid these kinds of incidents moving forward.” The administration has said the president supports the measure.
‘Cures 2.0′ Draft Bill Expected in June: Draft legislation to update the landmark biomedical innovation law 21st Century Cures will likely come out in early June, lawmakers behind the bill said. Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) indicated they want to pass their bill, known as Cures 2.0, by the end of the year, although they acknowledged the pandemic has set back their work. The bill offers a chance for an increasingly divided Congress to pass legislation to remove hurdles to cutting-edge treatments when science is moving at a rapid pace. Read more from Jeannie Baumann.
Emergent’s Vaccine Troubles to Get Probe: The House Select Subcommittee on the Coronavirus Crisis will hold a hearing tomorrow with Robert Kramer and Fuad El-Hibri, the chief executive officer and executive chairman of Emergent BioSolutions, respectively, according to a press release from the panel. The company, which had been contracted to produce Johnson & Johnson’s coronavirus vaccine, has been at the center of federal scrutiny over alleged quality control and staff training issues. The panel and the House Oversight and Reform Committee opened a joint investigation into Emergent last month.
Rubio Wants China Guardrails for Research Funds: Sen. Marco Rubio (R-Fla.) is proposing an amendment to a broad package of legislation (S. 1260) to counter China, aiming to protect research and development boosted by a massive infusion of funding from threats of espionage or theft. The change being sought by Rubio to a package based upon a bid from Senate Majority Leader Chuck Schumer (D-N.Y.) and Sen. Todd Young (R-Ind.) offers a preview of the sort of skirmishing that is likely to erupt, as Schumer pushes for floor passage by the end of May. The chamber is set to resume consideration of the motion to proceed to the legislation today. Read more from Daniel Flatley.
Ex-FDA Aide Joins Akin Gump: A former Food and Drug Administration official, Anna Abram, has joined top lobbying firm Akin Gump Strauss Hauer & Feld as a senior adviser. She served as deputy commissioner for policy, legislation and international affairs at the FDA, managing the development of policy goals. Her portfolio includes working on measures related to drug competition and biotechnology. Before that, Abram served as a health policy director to Sen. Richard Burr (R-N.C.), Megan R. Wilson reports.
The Coronavirus Pandemic
Biden Eyes More U.S. Jobs in Expansion of Vaccine Sharing Abroad: President Joe Biden began yesterday to make good on his promise that the U.S. would be an “arsenal” of coronavirus vaccines for the world, announcing he’d share FDA-authorized shots after criticism that his administration had hoarded hundreds of millions of doses. But he also signaled that he intends for U.S. manufacturers to hold or grow their share of the global market for vaccines, casting his decision to begin supplying other countries as an engine for American jobs. He cautioned that American contributions alone won’t resolve the crisis.
Biden yesterday announced that the U.S. would soon send at least 20 million shots made by Pfizer, Moderna and Johnson & Johnson to other countries for the first time, on top of a previous promise to share 60 million doses of the AstraZeneca vaccine that the Food and Drug Administration hasn’t cleared for U.S. use. The amount Biden initially plans to share falls far short of worldwide demand. Billions of shots are needed to fully inoculate people in other countries, especially in low-income nations, and snuff out the virus. Advocacy groups questioned whether the U.S. is doing enough to help countries that don’t have access to vaccines even after the president’s announcement. Read more from Josh Wingrove.
- The campaign to ship out Covid-19 vaccines to vast parts of the globe is grappling with a significant supply shortage, leaving many nations vulnerable and piling new pressure on wealthy governments to share doses. The initiative known as Covax expects the shortfall to reach about 190 million doses next month, UNICEF said today. Covax has shipped less than 40% of the doses it had intended to distribute by now, hurt by delays in supplies from hard-hit India, a global hub of vaccine production. Read more from James Paton.
Half of Non-Mask Wearers Will ‘Definitely Not’ Get Vaccinated: Americans who resisted wearing masks when they were urged to also were less inclined to get a Covid-19 vaccine, according to Kaiser Family Foundation data. The data, provided to Bloomberg Law, found that 13% of those who wear a mask some of the time or never said they had gotten vaccinated, compared with 34% of those who wear a mask all or most of the time. Half of non-mask wearers said they would “definitely not” get vaccinated, versus 7% of those who wear masks regularly, according to a survey taken the week of March 15. Read more from Jeannie Baumann.
CDC Deputy Director Set to Retire: A top-ranking Centers for Disease Control and Prevention official will retire this summer, the second member of the agency’s leadership to announce a departure in a month amid criticism of the agency’s communications and policy changes over emerging science on how the coronavirus spreads through aerosols and when wearing masks is recommended. “I’ll be leaving the agency for a retirement that I hope will allow more time for creative passions,” CDC Principal Deputy Director Anne Schuchat said, Elaine Chen reports.
- California Breaks With CDC, Keeping Mask Rule for Another Month
- N.Y. to Ease Mask Mandates, as Cuomo Says ‘Let’s Get Back to Life’
- Texas Reopening Barely Budged Either Economy or Virus Caseload
- OSHA Backs New CDC Mask Guidance for Fully Vaccinated Workers
- CytoDyn Falls as FDA Questions Benefit of Leronlimab for Covid-19
What Else to Know Today
Supreme Court Agrees to Assess Bid to Slash Abortion Rights: The U.S. Supreme Court will consider gutting the constitutional right to abortion, agreeing yesterday to hear Mississippi’s bid to ban the procedure in almost all cases after 15 weeks of pregnancy. The move suggests the court’s strengthened conservative wing may be ready to roll back the landmark 1973 Roe v. Wade ruling, which legalized abortion nationwide. The clash, which justices will hear in the nine-month term that starts in October, will be its first abortion case since Justice Amy Coney Barrett was confirmed.
Mississippi’s appeal seeks to let states outlaw abortion even before a fetus becomes viable, or capable of living outside the womb. That would eviscerate the core holding of 1992’s Planned Parenthood v. Casey ruling, which said states can’t levy significant restrictions before viability. The court in Casey didn’t pinpoint when viability occurs but suggested it was around 23 or 24 weeks at the time of the ruling. Read more from Greg Stohr.
- Why Supreme Court’s Newest Abortion Case Is a Big One: QuickTake
- The case has injected an unexpected culture-war issue into a 2022 midterm election season that both parties hoped would be a referendum on Biden’s economic plan. Whichever side wins at the high court could end up losing at the ballot box. Both abortion rights groups and anti-abortion activists are gearing up to make Roe v. Wade an unavoidable issue as the races for Congress and state government offices heat up. Read more from Gregory Korte.
- At the same time, the high court yesterday announced it will not decide on the legality of a Trump administration rule prohibiting federally funded family planning providers from referring clients for abortion. The court granted a petition for review in the case to weigh an HHS rule implementing Title X, but Biden’s administration asked the court to drop the case, arguing it would be moot before it could be decided, Stohr reports.
More from the High Court:
- High Court Passes on Reviewing J&J’s $70 Million Risperdal Award
- Amgen Skirts Supreme Court’s Review of Patents on Enbrel Drug
HHS’s Levine Has Packed Agenda: Rachel Levine has a full plate of health inequities she wants to tackle as the Biden administration’s assistant secretary for health, including Covid-19 vaccinations, LGBT health care, HIV, opioid use, and environmental impacts on health. Because of her position as the highest ranking openly transgender official in any administration, she is facing pressure to be a voice for her community and make a real impact on health policy in the next few years. Levine’s goals all come back to one message that Biden has made clear: The Covid-19 pandemic has exposed many existing inequities, and his administration will do what it can to fix them. Read more from Shira Stein’s exclusive interview with Levine.
- Eli Lilly, Sanofi Violated Law by Curbing Drug Discounts, U.S. Says
- Trans Youths Fight Arizona Medicaid Surgery Exclusion on Appeal
- Christian Medical Providers Try Again to Block LGBTQ Bias Rule
- Apellis Soars After Winning FDA Approval of Drug to Rival Alexion
- Menthols, E-Cigs, Cigars Hook Kids, Groups Say in Support of Ban
- Veterans’ Growing Demand for Mental Health Services
- HHS’s Preliminary Analyses Offer Incomplete Picture of Behavioral Health Demonstration’s Effectiveness
With assistance from Megan R. Wilson