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Lawmakers will likely focus on FDA staffing woes and speedy drug approvals as they kick off the first of a series of hearings on must-pass legislation to renew the fees that help fund the agency.
A hearing today of the House Commerce Committee’s health panel begins the congressional review process for the next round of user fee agreements between the FDA and the prescription drug, generic drug, and biosimilar industries. Congress must pass laws adopting the new deals for fiscal years 2023 through 2027, before the current agreements expire Sept. 30.
The user fee deals, which also contain agency commitments to the industry, come as the Food and Drug Administration seeks to rebuild public trust after its quick Covid-19 vaccine authorizations and controversial Alzheimer’s drug approval fueled questions on the agency’s independence and credibility.
Drugmaker fees play an integral role in speeding up application reviews, boosting medical product innovation, and offering new treatment options to Americans, policy analysts and trade groups say. Concerns have arisen, however, over whether the FDA relies too heavily on funds from the industries it is responsible for regulating. User fees make up roughly 45% of the FDA’s total budget.
Lawmakers are likely to use today’s hearing to garner support for provisions they would like to work into the user fee deals. Congress, for example, could add “its own regulatory priorities that could affect the accelerated approval program in light of the controversy surrounding Biogen‘s Aduhelm approval,” Bloomberg Intelligence Analyst Duane Wright said in a recent analysis. Read more from Celine Castronuovo.
Happening on the Hill
Omicron Supplemental Effort: Lawmakers have discussed the possibility of a bill to provide more resources to combat the coronavirus in light of the omicron virus, but it hasn’t been a top priority, Jack Fitzpatrick reports. Senate Majority Leader Chuck Schumer (D-N.Y.) said earlier this week lawmakers are still waiting on the Biden administration to send a request for the bill. “That’s been bubbling up,” Senate Appropriations Vice Chairman Richard Shelby (R-Ala.) told reporters yesterday. “That and disaster relief. That is not what’s driving the train, but it’s important.”
- Meanwhile, Senate Minority Leader Mitch McConnell (R-Ky.) said in a floor speech yesterday he wants unallocated pandemic relief funds to be accounted for and questioned the need for additional virus relief spending, Alisa Parenti reports.
Bid for Manchin’s Vote Pits Child Credit Against Subsidies: Senate Democrats hoping to regain momentum on their stalled economic agenda will need to make stinging decisions on their approach to helping families, pitting a more generous child tax credit against other benefit programs. Sen. Joe Manchin (D-W.Va.) continues to adhere to his stance that Democrats’ budget reconciliation package should cost less and include fewer programs that last longer. With Senate Democrats and Biden indicating there’s wide consensus on drug pricing, there isn’t much room for more programs under Manchin’s $1.5 trillion cap. Read more from Colin Wilhelm and Kaustuv Basu.
With Luján Out, Unclear Path for Califf in Near Term: A medical crisis that struck a Senate Democrat starkly illustrates the party’s tenuous control of the chamber and is already forcing them to delay votes on some of the president’s nominees. Sen. Ben Ray Luján (D-N.M.) is recovering in a hospital in New Mexico after having a stroke last week. Until he returns, Democrats are a vote short, as they seek to push through several of Biden’s priorities—including confirming Robert Califf to lead the FDA. Laura Litvan has more.
Biden Presses Congress to Fund ARPA-H: Biden pressed Congress to fund the Advanced Research Project Agency for Health during his relaunch of the Cancer Moonshot, making it clear he wants the new biomedical entity to be housed in the National Institutes of Health. “ARPA-H will have a “singular purpose” to drive breakthroughs and end cancer, Alzheimer’s and diabetes, among other diseases, the president said. “This would be a new kind of entity within the National Institutes of Health, the NIH with autonomy and authorities to drive unprecedented progress in biomedicine.”
His remarks to tie the proposal for the new biomedical research agency to the Cancer Moonshot comes one day after the House Energy and Commerce Committee announced a hearing on ARPA-H set for Feb. 8. The committee currently has two measures to authorize the agency, one to put ARPA-H within the NIH and a second that would place it more generally within the Department of Health and Human Services, Jeannie Baumann reports.
The Coronavirus Pandemic
New Virus Research Will Speed NIH’s Next Outbreak Response: Vaccines and treatments to counteract the next outbreak could reach patients even faster than the record pace set for developing Covid-19 shots under an ambitious plan from the NIH institute headed by Anthony Fauci.
A key part of the pandemic preparedness plan, announced yesterday by the National Institute of Allergy and Infectious Diseases, focuses on bolstering research on viruses known to cause illness in humans, or “prototype-pathogens,” and developing medical countermeasures to fight them off. Top public health leaders have warned that another pandemic is inevitable, and that it’s critical to take lessons from Covid-19 to combat the next one. Read more from Jeannie Baumann.
Disabled Texas Students Say Mask Mandate Ban Shuts Them Out: Texas Governor Greg Abbott should let schools decide whether requiring students and staff to wear masks will help disabled kids safely attend class, a lawyer for a group of such children told a federal appeals court. By following the Republican governor’s statewide ban on mask mandates, the schools are violating the Americans With Disabilities Act, since Covid-19 poses a greater threat to the children than to those who aren’t disabled, attorney Linda Coberly told a three-judge panel at a hearing yesterday in New Orleans. Read more from Laurel Brubaker Calkins.
- Europe Accelerates Move to Exiting Pandemic as Risk Alert Fades
- What Covid-19 Therapies Exist, and What Omicron Changes: QuickTake
What Else to Know Today
Tennessee Abortion Ban Based on Reason for Procedure Revived: A Tennessee law banning abortions sought because of the fetus’s sex, race, or prenatal diagnosis of Down syndrome is back on for now, as the Sixth Circuit yesterday paused an injunction that prevented it from taking effect. The one-sentence order issued by the Sixth Circuit stayed an injunction entered by a federal district court that found the law likely is void for vagueness, because it doesn’t reasonably inform doctors of the type of conduct that may trigger criminal prosecutions for performing an abortion based on a prohibited reason, Mary Anne Pazanowski reports.
DOL Sees Wins in Push Against Mental Health Coverage Disparities: The Department of Labor’s crackdown on disparities in mental health coverage is making progress with more than a half-million individuals gaining access to a previously excluded treatment for autism, a Biden administration official said yesterday. “We are already seeing some really good results” of the department’s investigation of health plan treatment of mental health benefits, Joanne Roskey, chief of the division of health investigations with the DOL’s Employee Benefits Security Administration, said. Read more from Sara Hansard.
Medical Marijuana Becomes Law in Mississippi: Medical marijuana is now legal in Mississippi, after the governor signed a bill yesterday establishing a program limiting patients to 3 ounces of cannabis a month. The legislation (S.B. 2095) revives a program approved by Mississippi voters in November 2020 only to be scuttled six months later by the state Supreme Court. Both chambers of the state Legislature passed the measure with veto-proof majorities. Read more from Jennifer Kay.
- Unions OSHA Health-Care Rule Case Gets D.C. Circuit Merits Panel
- Medicare Private Plans Would See 8% Revenue Jump Under Proposal
- Pulsed Electromagnetic Energy Possible Havana Syndrome Cause
- LogicBio Drops After Regulators Put Sunrise Clinical Trial on Hold
- Syros Gets FDA Orphan Drug Designation for MDS Tamibarotene
- Pfizer Says Stolen Trade Secrets Founded New Eli Lilly Partner
With assistance from Jeannie Baumann and Jack Fitzpatrick
To contact the reporter on this story: Brandon Lee in Washington at firstname.lastname@example.org