HEALTH CARE BRIEFING: House to Vote on $28 Million Formula Bill

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House Democrats propose providing $28 million in emergency funding for the Food and Drug Administration to address the shortage of infant formula in the US and provide tighter oversight of the industry.

The measure, unveiled Tuesday, is on the fast track to get a vote in the House Wednesday, House Majority Leader Steny Hoyer (D-Md.) said. Democrats are also planning to vote on a separate bill that would provide emergency authority to the Special Supplemental Nutrition Program for Women, Infants, and Children, known as WIC, to relax some regulations on purchases using program benefits.

House Appropriations Committee ranking member Kay Granger (Texas) said the bill constitutes a “blank check” for the FDA and fails to solve the near-term acute shortage. The bill, she said, doesn’t direct the FDA to devise a plan to increase supply and doesn’t tap $1 billion in Agriculture Department funds that could be used to streamline supply bottlenecks.

Meanwhile, executives from Abbott Nutrition and other major baby formula companies have agreed to testify May 25 before the House Energy and Commerce Committee on the root causes of the nationwide formula shortage. Abbott, which has been at the center of the firestorm over the shortages due to a shutdown of its main plant in Michigan after the deaths of two babies, will be represented by President Chris Calamari.

Speaker Nancy Pelosi (D-Calif.), at a news conference Tuesday, called the infant deaths “sinful.” She and House Energy and Commerce Chair Frank Pallone (D-N.J.) floated the possibility of indictments, without any providing details. Pallone suggested the contamination could be the result of “criminal negligence.”

A total of four children were sickened by cronobacter bacteria. No further cases of children being sickened by formula have since been reported, according to the Centers for Disease Control and Prevention, which closed its investigation of the outbreak last week. Abbott has said its products are not to blame for the illnesses and deaths. Top Food and Drug Administration officials said on a call with reporters Monday evening it was too early to tell.

Also testifying next week are FDA Commissioner Robert Califf, as well as Nestle SA’ Gerber vice president Scott Fitz and Reckitt Benckiser Group senior vice president Robert Cleveland. Califf also is scheduled to testify before an Appropriations Committee hearing on Thursday. Erik Wasson has more.

Related:

Happening on the Hill

Wednesday’s Hearings:

The House Judiciary Committee holds a Wednesday hearing on protecting access to abortion services.
The House Education and Labor Committee holds a Wednesday markup, with plans to consider H.R. 5407 and H.R. 7780, two mental health-related measures.
The House Homeland Security Border Security Subcommittee holds a Wednesday hearing on the government’s efforts to stop the flow of opioids into the US.
The Senate Health, Education, Labor and Pensions Committee holds a Wednesday hearing on cybersecurity in the health-care industry.
BGOV Calendar: See full list of hearings.

Bills Set for Passage: The House plans to vote on several measures related to veterans’ health care under suspension of the rules—which requires a two-thirds majority for passage—including:

S. 2102, which would require the Veterans Affairs Department to provide mammograms to veterans who served in locations associated with exposure to burn pits. The Senate passed the bill by voice vote on March 24. For more, see the BGOV Bill Summary by Naoreen Chowdhury.
S. 2533, which would expand breast-imaging services for veterans. The Senate passed the bill by voice vote on March 23. For more, see the BGOV Bill Summary by Christina Banoub.

Panel to Weigh Mental Health, User Fees: The House Energy and Commerce Committee will mark up a bipartisan package of mental health bills Wednesday that would slightly strengthen parity rules and end a special waiver needed to prescribe drugs to combat substance use disorder. The legislation represents some “low-hanging fruit” that could help many Americans get access to mental health and addiction treatment services, advocates say.

“The package is a good step forward I don’t think it’s everything we need to make a difference,” Ellen Glover, campaign director for the People’s Action Institute, which advocates on drug policy, said. That group has lobbied to back the MAT Act, part of the larger package, which would end the need for health-care providers to get a special waiver from the federal Drug Enforcement Administration to prescribe buprenorphine. Currently that waiver limits how many patients a doctor can prescribe it.

That package would also reauthorize several federal health programs and require self-funded, non-federal governmental plans to comply with laws requiring the same coverage for mental health care as other types of health care. Lawmakers say they need to act to slow the rise in overdose deaths in the US, which hit an all-time high in 2021 at more than 107,000, Alex Ruoff reports.

The committee will also mark up a comprehensive package reauthorizing the user fees that help fund the FDA’s operations. The health subcommittee advanced the bill last week by a 30-0 vote. The bill, which faces a Sept. 30 deadline, includes provisions to improve the accelerated approval pathway and remove barriers to generic drug competition. It also includes measures granting the FDA powers to require drug and device companies to submit diversity action plans for their clinical trials.

Advocacy group Doctors for America, co-founded by US Surgeon General Vivek Murthy, visited Capitol Hill this week to lobby for more reforms to the user fee package, including language that would automatically have a drug’s accelerated approval expire if follow-up studies don’t show a clinical benefit. Members of the group’s FDA Task Force met with lawmakers to “discuss the value of a transparent FDA approval and review process,” the group said in a press release, Celine Castronuovo reports.

Meanwhile, the Senate’s user fees bill would give more power to the FDA over cosmetics, dietary supplements and lab-developed tests. The proposals were unveiled in a draft by the heads of Health, Education, Labor and Pensions Committee. “This legislation will ensure FDA has the resources it needs to do its work,” Chairwoman Patty Murray (D-Wash.) said in a statement. Read more from Castronuovo.

Proposed Cancer Office Cuts Blamed on Timing: The proposal to cut nearly $200 million from the National Cancer Institute as the White House reignites the Cancer Moonshot stems from the timing of overlapping spending plans and does not necessarily reflect the administration’s priorities, NIH’s acting director said. The administration made its funding proposal for the next fiscal year based on the only figures it had at the time, from fiscal 2021, acting Director Lawrence Tabak told a Senate panel.

The Senate Appropriations Labor-HHS-Education subcommittee hearing on Tuesday examined the National Institutes of Health’s fiscal 2023 budget request. The Biden administration’s plan would increase the medical research agency’s funding by about $270 million over the $45 billion level enacted for 2022, while providing a $4 billion hike for the Advanced Research Projects Agency for Health, or ARPA-H. Read more from Jeannie Baumann.

Lawmakers Press Biden to Put ARPA-H in Their States: Lawmakers are lobbying the White House to put a new biomedical research agency in their home states, with delegations from Texas and Massachusetts sending warring letters recently. Sens. Ed Markey (D-Mass.) and Elizabeth Warren (D-Mass.), and the state’s full House delegation, told Secretary Xavier Becerra that their state would be the ideal place to house the Advanced Research Project Agency for Health (ARPA-H).

Sen. John Cornyn (R-Texas) joined more than a dozen of his Texas colleagues writing a similar letter to Becerra. There’s been an effort, started by Sen. Richard Burr (R-N.C.) and joined by several lawmakers, to prohibit the government from placing ARPA-H’s future headquarters in the Washington, D.C. area. That means the Biden administration will get to choose what area of the country gets the new agency and the benefit of billions of dollars in federal research funds, Alex Ruoff reports.

The Coronavirus Pandemic

Covid Supplies to Wane in Summer, Official Warns: Supplies of key Covid-19 therapies are in danger of running out as soon as this summer, a senior health official said, as the Biden administration seeks more funds to fight the pandemic. Stocks of Eli Lilly’s monoclonal antibody are expected to be exhausted by July, the official said, and newer omicron subvariants have rendered other monoclonal treatments ineffective. Supplies of AstraZeneca’s Evusheld antibody treatment may dry up by the fall, the official said.

The US government is preparing to extend the public health emergency declaration that allows authorization and use of vaccines and drugs like Pfizer’s antiviral Paxlovid in the pandemic. The Biden administration has been wrangling with Congress to approve funds to obtain more medical supplies and support programs to fight the coronavirus. Stockpiles of Paxlovid will last through fall, but the US will need to buy additional courses to continue providing it beyond that, the official said. Madison Muller has more.

Pfizer Booster for Children Gets FDA Authorization: Pfizer and BioNTech got US emergency use authorization for their Covid vaccine booster shot for kids ages 5 to 11, a move to bolster protection in school-aged kids as contagious omicron subvariants spread across the country. The Food and Drug Administration clearance allows the use of the booster at least five months after children receive the second of their first two shots. Read more from Robert Langreth.

Covid Death Toll Officially Hits 1 Million: At least 1 million people in the U.S. have died of Covid-19, a key tally says, almost 2 1/2 years into a pandemic that continues to kill hundreds of Americans a day. The total was marked by Johns Hopkins University, one of several organizations tracking pandemic data. The actual number is certainly higher, since it can take weeks for some statistics to filter in. It also doesn’t account for deaths indirectly tied to Covid, like the stresses put on hospitals. Drew Armstrong has more.

US Releases More Home Tests: The White House has released another round of free at-home Covid tests available through mail order. Each US household is eligible for eight tests at Covid.Gov/Tests. This is the third round of free tests since the program first launched in January. A second round became available in March. The latest tranche comes as the more infectious BA.2 strain has meant wider spread, even among those vaccinated, boosted and with prior infections. Read more from Martine Paris.

More Headlines:

What Else to Know Today

Drug Dispensing Errors Get FDA Focus: Drugmakers should make sure their product labels are easy to read and prominently display dosing information to prevent dispensing errors, the FDA said in finalized guidance. The guidance, filed Tuesday in the Federal Register, aims to help makers of pharmaceutical and biologic products know what factors to think about to ensure that their labeling is “designed to promote safe dispensing, administration, and use of the product.” Celine Castronuovo has more.

Abortion Patients’ Privacy—HIPAA Explained: The widely misunderstood HIPAA health privacy law will offer little protection to patients who defy anti-abortion laws and later seek treatment for complications if Roe v. Wade is reversed. Many patients believe HIPAA guarantees them a right to absolute privacy. But patients in states with bans post-Roe would need to be careful what they disclose because the law allows providers to report health information to law enforcement. Allie Reed explains.

Michigan’s Court of Claims granted a temporary injunction Tuesday halting enforcement of a 1931 law that criminalizes abortion on the chance that the US Supreme Court overturns its abortion-rights precedents. Judge Elizabeth Gleicher sided with Planned Parenthood of Michigan, who argued that the state’s Constitution recognizes a right to bodily integrity. Read more from Alex Ebert.
A 2021 FTC settlement with fertility app Flo Health after it allegedly compromised users’ sensitive health information may offer a window into how the federal government could partially protect that data if Roe is overturned. The draft opinion on Roe prompted calls to delete apps tracking menstruation amid fears that states with new abortion bans could use data from those apps for criminal proceedings. Read more from Jeannie Baumann.

Drugmakers Win Challenge to Drug Rebate Rule: A rule issued by the US Centers for Medicare and Medicaid Services requires drugmakers to include discounts offered directly to patients when calculating the “best price” of drugs for purposes of Medicaid’s drug rebate program exceeds the agency’s authority, a federal judge in D.C. ruled Tuesday. The challenged rule, issued in 2020 by CMS, is inconsistent with the federal Medicaid rebate law, Judge Carl J. Nichols said. Read more from Maeve Allsup.

More Headlines:

With assistance from Alex Ruoff and Celine Castronuovo

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

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