HEALTH CARE BRIEFING: Senators to Vote on Doomed Abortion Bill

Senate lawmakers will go on the record today on whether they support the 1973 Roe v. Wade decision that granted the constitutional right to an abortion.

Senate Majority Leader Chuck Schumer (D-N.Y.) set up the vote in the wake of the leak of a draft opinion by a majority of the court that would overturn Roe and return decisions on abortion to the states. Schumer has acknowledged he lacks the 60 votes needed to advance the bill (S. 4132) to establish a federal right to abortion. But Democrats are intent on highlighting an issue they believe will help them in an otherwise difficult midterm election environment.

• BGOV Bill Summary: S. 4132, Codify Abortion Access

Schumer said the vote will force Senate Republicans to take a position as many GOP-controlled state legislatures prepare to pass “extreme anti-choice legislation that will send women’s rights back into the stone age.”

McConnell claims he wouldn’t push a federal ban on abortion if his party regains the majority next year and “the sentiment in my conference is for this issue to be dealt with at the state level if we are in fact confronted with a final Supreme Court decision that throws this issue back into democratic processes.”

Yellen Says Roe Rollback Threat to Economy: Treasury Secretary Janet Yellen also jumped into the politically charged issue on Tuesday, saying the economy would suffer if the Supreme Court limits abortion access. Eliminating the right to access abortion services “would have very damaging effects on the economy and would set women back decades,” she told the Senate Banking Committee. Read more from Christopher Condon.

More Headlines:

• Abortion Ballot Measures Multiply as States Brace for Ruling
• Hochul Allots $35 Million to Protect New York Abortion Clinics

Also Happening on the Hill

House Panel to Mark Up Health Bills: A House subcommittee Wednesday will mark up six health care bills that represent rare bipartisan agreement in areas like mental health and pharmaceuticals. The House Energy and Commerce health subcommittee will weigh bills ranging from authorization of Biden’s proposed new biomedical agency to a slew of mental health measures and a new agreement on the Food and Drug Administration’s user fee programs.

Together, the bills “will ensure safe and effective drugs and biologics, support mental health and well-being, and strengthen public health,” Energy and Commerce Chair Frank Pallone (D-N.J.) and Health Subcommittee Chair Anna Eshoo (D-Calif.) said in a joint statement.

The five-year authorization of FDA’s user fees, which fund a considerable part of its drug and device approval programs, is set to expire Sept. 30. The FDA negotiates with industry to set the fees, which Congress authorizes via legislation, along with goals for review times. House Energy and Commerce leaders released a bipartisan package (H.R. 7667) that would reauthorize FDA user fees. It would also make changes to cut down drug prices, increase the availability of generics, and strengthen postmarket clinical study requirements for fast-track approvals of drugs. Christina Banoub breaks down the bill in a BGOV OnPoint.

In addition to H.R. 7667, the other five bills set for a markup are:

• H.R. 7666, the “Restoring Hope for Mental Health and Well-Being Act,” introduced by Pallone and ranking member Cathy McMorris Rodgers (R-Wash.);
• H.R. 7233, the “Keeping Incarceration Discharges Streamlined for Child and Accommodating Resources in Education Act” or “KIDS CARES Act,” introduced by Reps. Richard Hudson (R-N.C.) and Annie Kuster (D-N.H.);
• H.R. 623, the “Gabriella Miller Kids First Research Act 2.0,” introduced by Rep. Jennifer Wexton (D-Va.);
• H.R. 3771, the “South Asian Heart Health Awareness Act of 2021,” introduced by Rep. Pramila Jayapal (D-Wash.); and
• H.R. 5585, the “Advanced Research Project Agency-Health Act,” introduced by Eshoo.

Health Hearings on the Hill:

• The House Appropriations Labor-HHS-Education Subcommittee has scheduled a hearing on Wednesday on the National Institutes of Health’s budget request for fiscal 2023. The NIH acting chief, Lawrence Tabak, and National Institute of Allergy and Infection Diseases Director Anthony Fauci are among those set to attend.
• The House Appropriations Labor-HHS-Education Subcommittee also scheduled a hearing on “maximizing” the well-being of elderly people. Elder Justice Coalition Director Robert Blancato and Senior Citizens Inc. CEO Patricia Lyons are among those set to testify.
• Follow BGOV’s nomination and vote tracker here, and click here for a complete list of this week’s hearings and markups.

Health Bills Set for Passage:

• The House plans to vote under suspension of the rules—which a requires a two-thirds majority for passage—legislation (S. 4119) that would extend for about two years the Justice Department’s compensation program for individuals who developed illnesses from radiation exposure related to nuclear weapons testing and uranium mining. Read a Bill Summary by BGOV’s Brittney Washington.

Probe Finds Emergent Hid Quality Issues From FDA: Quality-control issues at contract manufacturer Emergent BioSolutions led to the disposal of about 400 million doses of coronavirus vaccines, more than was previously disclosed, according to a new report from the House Oversight and Reform Committee and the Select Coronavirus Crisis Subcommittee. The report suggests that Emergent hid evidence of the contamination of vaccines made by Johnson & Johnson and AstraZeneca from US regulators. Read more from Riley Griffin.

Red Cross Urged to Bargain for Worker Union: Lawmakers are imploring the American Red Cross to negotiate a fair contract with the coalition of worker unions that represent about 4,000 employees across the country. Workers overseeing the country’s supply of blood deserve a collective bargaining agreement that provides affordable health-care benefits and acknowledges the health and safety risk they’ve faced through the Covid pandemic, 47 House members said in a letter to Red Cross management. Read more from Paige Smith.

Menthol Ban to Test FDA’s Power on Tobacco

The FDA’s proposals to ban menthol cigarettes and flavored cigars will test its authority to create new product standards for the tobacco industry. The Food and Drug Administration issued long-awaited draft standards targeting menthol and other flavored tobacco products that can make smoking harder to quit. The two proposals have already widened tensions between the agency and tobacco manufacturers, who oppose the FDA’s plans.

As the agency works to finalize those proposals—which are then likely to face an industry challenge—it should weigh the public health standard it uses, and analyze the potential for more tobacco products to enter the black market, attorneys who specialize in tobacco policy said. The FDA “has authority to implement tobacco product standards based on a finding that those standards are appropriate for the protection of public health,” said Bryan Haynes, a partner with Troutman Pepper. However, that authority is “not without limits,” he said.

The agency will finalize the proposals after a public comment period that ends July 5. Major tobacco and vaping companies that would be impacted by a menthol ban, including Altria Group, Imperial Brands, and British American Tobacco, have said that they hope to communicate their concerns to the FDA as it formalizes the proposals.

Attorneys said the FDA needs to provide a reasonable amount of time for public input, and evidence that the standards wouldn’t unreasonably stretch the FDA’s authority. Under federal law, the FDA can issue tobacco product standards deemed “appropriate for the protection of the public health.” Marc Scheineson, a former agency official, said the FDA “can’t be arbitrary and capricious” in proposing new standards. Read more from Celine Castronuovo.

What Else to Know Today

FDA’s Vaccine Head Wants Warp Speed for Drugs: Lifesaving medicines could reach patients faster under a pilot drug review program the FDA’s biologics director wants to pursue based on lessons learned from America’s coronavirus response. “For rare disease patients, where you have lethal diseases, the most common question that I’ve gotten at meetings I’ve gone to over the past year is: ‘Why can’t we have our own Operation Warp Speed?’” Peter Marks, head of the FDA Center for Biologics Evaluation and Research, said. Read more from Jeannie Baumann.

• Also Tuesday, Marks said the FDA isn’t lowering its efficacy standard for Covid-19 shots, while acknowledging they may be less effective for some groups such as kids. “Overall, the vaccines have to be at least 50% effective. And we will maintain that standard,” he said. He was explaining why it’s taking longer for the FDA to review newer vaccine applications compared with those for Pfizer-BioNTech and Moderna’s in 2020. He acknowledged questions about the agency’s review times for the latest vaccine applications have arisen frequently. Read more from Baumann.

FDA Taking Steps on Infant Formula Shortages: The FDA says it’s been taking steps to increase the availability of infant and specialty formula products, including: “Meeting regularly with major infant formula manufacturers to better understand their capacity to increase production” of formulas. And expediting FDA reviews of changes to manufacturing will also help increase supply—especially for specialized formulas for medical needs, it said. Commissioner Robert Califf says the agency is “working tirelessly” to alleviate supply issues, Jim Silver reports.

HHS Says Drug Discount Rule Breakers Face Fines: The Health and Human Services Department should be allowed to penalize drugmakers who violate the rules of a federal program designed to help lower-income Americans afford drugs, the HHS told the Third Circuit. HHS is appealing a lower court ruling that partially vacated enforcement letters it sent to Novo Nordisk Pharma and Sanofi-Aventis, threatening monetary penalties if the companies don’t lift limits on discounts provided to pharmacies contracting with health providers in the 340B program. Allie Reed has more.

• Separately, HHS said it has the authority to mandate drugmakers offer steep discounts to off-site pharmacies under the federal program. HHS is appealing to the D.C. Circuit a lower court ruling that it can’t force drugmakers to offer drug discounts under the 340B program without congressional action. The district court was wrong to conclude that because that law “has no explicit prohibition on adding conditions to the discounted price,” the Department of Health and Human Services said. Read more from Reed.

DOJ Urges SCOTUS to Reject Bayer Roundup Appeal: The Biden administration urged the Supreme Court to reject Bayer’s bid to stop potentially billions of dollars in claims that its top-selling Roundup weedkiller causes cancer. Bayer is challenging a $25 million award to Edwin Hardeman, a California man who says that decades of exposure to Roundup caused his non-Hodgkin’s lymphoma. Bayer argues that federal approval of Roundup’s label meant that Hardeman’s lawsuit—and others like it—can’t go forward. Read more from Greg Stohr.

R&D Hub Sought for Autoimmune Diseases: The NIH’s patchwork approach to autoimmune disease research, ranging from lupus to arthritis, hinders the agency’s ability to offer maximum output on the more than $1 billion it spends per year on these conditions, a National Academies report found. A report released Tuesday by the National Academies of Sciences, Engineering, and Medicine called on the National Institutes of Health to streamline work on such diseases, recommending the creation of a single office to coordinate research. Jeannie Baumann has more.

Employers Said Turn to Insurers for Hospital Data: Many employers will likely use data compiled by health insurers and health care plan administrators to meet requirements that they provide information on hospital rates, a Labor Department official said. Group plans sponsored by employers and insurers are required to have public information on hospital rates in machine-readable files in less than two months. Large employers that sponsor health plans are scrambling to compile the voluminous information. Read more from Sara Hansard.

More Headlines:

• HHS to Allocate $16 Million for Title X Family Planning Program
• Estate’s Missed Medical Diagnosis Suit Filed Too Late in Indiana
• Challenge to Visa Ban for Mexican Plasma Sellers May Proceed
• Atria Senior Living Pays $1.3 Million to Settle OT, Break Lawsuit

With assistance from Alex Ruoff, Nancy Ognanovich, Emily Wilkins, and Zach C. Cohen

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