Infant formula makers are expected to notify the FDA within five business days of a supply chain disruption under the Senate’s latest user fee proposal that is expected to go to committee on Tuesday.
A replacement amendment to the proposal (S. 4348), which was obtained by the Bloomberg Act, contains several provisions aimed at improving the Food and Drug Administration’s oversight of infant formula manufacturers after a recall at a facility Abbott caused a nationwide shortage. The user fee package is considered must-have legislation and reauthorizes payments that the US drug and device industries make to help fund the agency.
The Senate legislation would require the Government Accountability Office to publish a report on the FDA’s executive operations division and how it prioritizes complaints and other correspondence it receives from outside the FDA. The agency cited isolated failures within the FDA’s mailroom as part of the reason management was not immediately made aware of allegations of potentially contaminated infant formula from the plant. Abbott.
The latest proposal would also require the FDA to develop regulations to facilitate the importation from Canada of certain drugs for personal use. Nor was it part of the version proposed last month by the President of Health, Education, Labor and Pensions Patty Murray (D-Wash.) and rating member Richard Burer (RN.C.). Sen. Bernie Sanders (I-Vt.) told Bloomberg Law last week that he was seeking to propose an amendment allowing the importation of prescription drugs.
- The latest HELP committee bill also adds other measures of the House package that were not included in the previous version of the Senate. The legislation aims to strengthen generic drug competition by allowing the FDA to approve a generic drug even if the label of the branded version changes during the review process. The agency would be required to provide regular updates to Congress on user fee negotiations and publish meeting minutes within 30 days.
- Language to revamp the accelerated approval path remain in the Senate HELP package, although it does not include additional fast-track drug provisions that some advocacy groups had hoped would be added.
- Measures to strengthen pediatric cancer research and the diversity of clinical trials was not included in the superseding amendment. Language based on the Give Kids a Chance Act (HR 6972) is not in the Senate record.
Lawmakers are working to get a set of user fees finalized before the current authorization expires on September 30 this year. Murray’s committee is expected to mark the bipartisan package on Tuesday after the House passed its own version on June 8. Learn more about Celine Castronuovo.
More headlines on the shortage:
It’s happening on the Hill
- The Senate Committee on Health, Education, Labor and Pensions will also mark Article 958, to amend the Public Health Services Act to expand the criteria for granting new access points for community health centers.
- The House Special Subcommittee on the Coronavirus Crisis holds oversight hearing on federal efforts to prevent and prosecute pandemic relief fraud.
- BGOV Calendar: See the full week of events.
Democrats want an investigation into online formula sales: Energy and Household Commerce Chair Frank Pallone Jr. (DN.J.) and Chair of Education and Labor Bobby Scott (D-Va.) urged the Federal Trade Commission to probe online marketplaces, including Facebook, eBay and Amazon, “that are failing to protect consumers from the fraudulent and deceptive sale of infant formula.” They argue that marketplace policies are insufficient to combat price measurement and fraud. Read their letter here.
GOP states will circle the fight against vaccines: A 14-state coalition led by Louisiana may have another chance to strike down Biden’s mandate that all healthcare workers should be vaccinated against Covid to keep their jobs, under a court ruling on Monday New Orleans Federal Appeals Department. The three-judge appeals panel — all appointed by Republicans — rejected a 2021 Louisiana trial judge’s ruling blocking Biden’s health worker vaccine requirement. Learn more about Laurel Brubaker Calkins.
WADA denounces opposition to abortion restrictions: The American Medical Association has gone further than ever in its reproductive health policies as the US Supreme Court nears a ruling that could cede abortion rights to states. The AMA’s governing body voted Monday night to pass resolutions that oppose state efforts to criminalize abortion and other reproductive health services. The preeminent association of doctors and medical students had previously taken the position of tying its abortion-related policies to the law. Learn more about Shira Stein.
SCOTUS rejects Opioid CEO’s conviction appeal: The United States Supreme Court has dismissed an appeal by Insys Therapeutics founder John Kapoor, the first top pharmaceutical executive convicted of crimes related to highly addictive opioid painkillers. Judges upheld Kapoor’s 5.5-year prison sentence following his 2019 conviction in federal court in Boston after prosecutors accused Kapoor of a scheme to bribe doctors and deceive insurers to increase benefits. sales of the company’s Subsys liquid opioid. Greg Stohr has more.
NC said to pay for the care of trans workers: A North Carolina health plan for state employees must pay for treatment ‘causing or related to sex reassignment or modification’ because the plan’s exclusion of such care is discriminatory, a federal court has found. the state. North Carolina State Health Plan for Teachers and State Employees Exclusion from Gender Confirmation Coverage Discriminates against Trans Staff in Violation of the Equal Protection Clause and Title VII, he said. Mary Anna Pazanowski has more.
Industry & Regulation
Traveling nurses expose hospital employers to legal risks: On-demand nursing options are growing as hospitals turn to outside companies to fill staffing gaps. But this carries risks for both parties. The gig model that relies on independent contractors is more complicated in the healthcare industry than it is for carpooling and food delivery. The trend could leave facilities and the companies that serve them vulnerable to accusations of misclassification, employer disputes and wage laws, attorneys say. Allie Reed and Erin Mulvaney have more.
Telehealth physicians prepare for the end of HIPAA flexibility: Telehealth providers should prepare to comply with HIPAA health privacy law once the federal public health emergency is over, the Department of Health and Human Services said in a guide. Healthcare providers, plans and clearinghouses transmitting electronic health records were previously exempt from having to comply with the Pandemic Health Insurance Portability and Accountability Act 1996 . Learn more about Allie Reed.
To contact the reporter on this story: Brandon Lee in washington at [email protected]