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Infant formula makers would need to notify the FDA within five business days of a supply chain disruption under the Senate’s latest user fee proposal that’s expected to go before a committee markup Tuesday.
A substitute amendment to the proposal (S. 4348), which was obtained by Bloomberg Law, contains multiple provisions to improve Food and Drug Administration oversight of infant formula manufacturers after a recall at an Abbott facility propelled a nationwide shortage. The user fee package is considered must-pass legislation and reauthorizes the payments that the US drug and device industries make to help fund the agency.
The Senate legislation would require the Government Accountability Office to issue a report on the FDA’s Division of Executive Operations and how it prioritizes complaints and other correspondence it receives from outside the FDA. The agency has cited isolated failures within the FDA’s mailroom as part of the reason why leadership was not immediately made aware of claims of potentially contaminated infant formula from Abbott’s plant.
The latest proposal would also require the FDA to develop regulations to facilitate the importation from Canada of some drugs for personal use. That also wasn’t part of the version offered last month by Health, Education, Labor and Pensions Chairwoman Patty Murray (D-Wash.) and ranking member Richard Burr (R-N.C.). Sen. Bernie Sanders (I-Vt.) told Bloomberg Law last week that he was looking to propose an amendment allowing for the importation of prescription drugs.
- The latest HELP committee bill also adds in other measures from the House package that weren’t included in the prior Senate version. The legislation seeks to bolster generic drug competition by allowing the FDA to approve a generic drug even if the brand-name version’s label changes during the review process. The agency would be required to give regular updates to Congress on user fee negotiations, and to publish the minutes from meetings within 30 days.
- Language to revamp the accelerated approval pathway remain in the Senate HELP package, though it doesn’t include additional provisions on fast-tracked drugs that some advocacy groups hoped to see added.
- Measures to bolster pediatric cancer research and clinical trial diversity didn’t make it into the substitute amendment. Language based on the Give Kids a Chance Act (H.R. 6972) isn’t in the Senate package.
Lawmakers are working to get a finalized user fee package wrapped up before the current authorization expires Sept. 30 this year. Murray’s committee is scheduled to mark up the bipartisan package on Tuesday after the House passed its own version June 8. Read more from Celine Castronuovo.
More Shortage Headlines:
Happening on the Hill
- The Senate Health, Education, Labor, and Pensions Committee will also mark-up S. 958, to amend the Public Health Service Act to widen criteria for new access points grants for community health centers.
- The House Select Subcommittee on the Coronavirus Crisis holds an oversight hearing on federal efforts to prevent and prosecute pandemic relief fraud.
- BGOV Calendar: See the full week of events.
Democrats Want Probe of Formula Sales Online: House Energy and Commerce Chair Frank Pallone Jr. (D-N.J.) and Education and Labor Chair Bobby Scott (D-Va.) urged the Federal Trade Commission to probe online marketplaces—including Facebook, eBay, and Amazon—”that fail to protect consumers from the fraudulent and deceptive sale of infant formula.” They argue that the marketplaces’ policies are insufficient to combat price gauging and fraud. Read their letter here.
Before the Courts
GOP States to Get Do-Over on Vaccine Fight: A Louisiana-led coalition of 14 states may get another shot at invalidating Biden’s mandate that all health-care workers get Covid vaccinations to keep their jobs, under a ruling Monday by a New Orleans federal appeals court. The three-judge appellate panel—all appointed by Republicans—threw out a Louisiana trial judge’s decision from 2021 blocking Biden’s health worker vaccine requirement. Read more from Laurel Brubaker Calkins.
AMA Stakes Out Opposition to Abortion Restrictions: The American Medical Association went further than it has ever gone in its reproductive health policies as the US Supreme Court nears a decision that could cede abortion rights to the states. The AMA’s policymaking body voted Monday evening to adopt resolutions that oppose state efforts to criminalize abortion and other reproductive health services. The preeminent association of physicians and medical students previously had taken the position of tying its abortion-related policies to the law. Read more from Shira Stein.
SCOTUS Rejects Opioid CEO’s Conviction Appeal: The US Supreme Court turned away an appeal by Insys Therapeutics founder John Kapoor, the first top pharmaceutical executive convicted of crimes tied to the highly addictive opioid painkillers. The justices kept Kapoor’s 5 1/2-year prison sentence on after his 2019 conviction in federal court in Boston after prosecutors accused Kapoor of a scheme to bribe doctors and deceive insurers to boost sales of the company’s liquid opioid Subsys. Greg Stohr has more.
N.C. Told to Pay for Trans Workers’ Care: A North Carolina health plan for state employees must pay for treatments “leading to or in connection with sex changes or modifications” because the plan’s exclusion of such care is discriminatory, a federal court in the state found. North Carolina’s State Health Plan for Teachers and State Employees’ exclusion of gender confirmation coverage discriminates against trans staff in violation of the Equal Protection Clause and Title VII, it said. Mary Anna Pazanowski has more.
- High Court Skips UnitedHealth’s $600,000 Case on Teen ATV Crash
- High Court Denies Review in Cathode-Ray Tube Price-Fixing Battle
- GSK Faces Suit Under Connecticut Law Over Harm From Generics
- WinCo Foods Beats Claims for Drug Testing Cost Reimbursement
- Challenge to Voluntary New Jersey Medical Aid-in-Dying Law Fails
Industry & Regulation
Travel Nurses Expose Hospital Employers to Legal Risks: Gig nursing options are growing as hospitals turn to outside firms to fill staffing gaps. But that carries risks for both sides. The gig model that relies on independent contractors is more complicated in the health-care sector than for ridesharing and food delivery. The trend could leave facilities and the companies serving them vulnerable to misclassification accusations, joint-employer disputes, and wage laws, attorneys say. Allie Reed and Erin Mulvaney have more.
Telehealth Doctors Brace for End of HIPAA Flexibility: Telehealth providers should prepare to comply with the HIPAA health privacy law once the federal public health emergency ends, the Department of Health and Human Services said in a guidance. Health-care providers, plans, and clearinghouses transmitting electronic health records were previously exempt from having to comply with the Health Insurance Portability and Accountability Act of 1996 during the pandemic. Read more from Allie Reed.
- EPA to Release PFAS Drinking Water Health Advisories Wednesday
- Murder-Suicides by Pilots Vex Airlines as Mental Health Fears Rise
- WHO Weighs Renaming Monkeypox Virus to Minimize Stigma, Racism
- Eli Lilly and Incyte’s Olumiant Gets FDA Nod For Alopecia
- Bluebird Jumps as Gene Therapies Get FDA Advisers’ Endorsement
To contact the reporter on this story: Brandon Lee in Washington at email@example.com