— Two federal programs that compensate people who sustain injuries caused by pandemic vaccines or treatments face so many claims that patients wait years for potential payments.

— The Senate HELP Committee presented a bill this would reauthorize the FDA’s medical product user fee programs.

— The Federal Trade Commission and the Department of Justice announced a workshop on the application of antitrust laws in the pharmaceutical sector.

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VAX INJURY PROGRAMS ARE OVERWHELMED LIKE REFORM STALLS — The two federal programs meant to compensate people injured by vaccines or pandemic countermeasures have thousands of claims unlikely to be resolved — or paid — anytime soon, Lauren reports.

The Countermeasures Compensation Scheme, which currently covers vaccines and treatments for Covid-19, has received more than 8,000 complaints in the two-plus years since the disease surfaced, compared to 500 since the outbreak. 2009-2010 H1N1 influenza pandemic. Patient advocates and lawyers say the program has a stingy reputation, paying just 29 claims in its 12-year history.

But they also worry that the 36-year-old National Vaccine Injury Compensation Scheme, which now covers nearly three times as many vaccines as it did when it was created, is ill-equipped to handle Covid-related claims once the CDC recommends routine Covid shots. Despite bipartisan work on the issue — and a handful of health care bills that have come before Congress this year — lawmakers have failed to act.

Absent any change, those working on the issue worry that the optics of an override system could fuel vaccine hesitancy if the public confuses the situation with too many injuries flooding the programme, while its coverage area has expanded without a commensurate increase in resources.

“The system could easily be crushed by the new burden if the existing backlog is not quickly addressed and the program modernized,” said Rep. Lloyd Doggett (D-Texas), who has sponsored two bills to overhaul the VICP.

KFF: MISINFO ON VACCINES MAINTAINS CONTROL OVER PREGNANT PEOPLE — Pregnancy-related misinformation around Covid-19 vaccines persists despite efforts by federal health officials to encourage vaccinating pregnant women, according to a survey recently released by the Kaiser Family Foundation.

Nearly 30% of women who are pregnant or planning to become pregnant believe at least one misinformation about vaccines and pregnancy, the group found, with elements ranging from a recommendation against vaccinating pregnant women to the belief that vaccines cause infertility. About a third of respondents said they had heard the false claims KFF asked about and were unsure if they were true, meaning more than six in 10 adults believe or are unsure of the misinformation.

SENATE HELPS LEADERS INTRODUCE FDA USER FEES BILL — On Friday, members of the Senate HELP Committee introduced the bill that would reauthorize human medical product user fee programs for the FDA.

“This bipartisan bill marks an important step in building these successful partnerships to ensure the FDA’s review and approval process remains nimble and forward-looking for the next generation of medical products, treatments and remedies,” Richard Burr (RN.C.), who presented the text with President Patty Murray (D-Wash.), said in a statement.

The bill, called the FDA Safety and Landmark Advancements Act, contains some changes from the bill introduced in May.

Accelerated approval: Like the House user fee bill, the Senate bill bolsters the agency’s authority around the zero-responsible approval pathway for drugs like Aduhelm, the controversial anti-aging drug. Alzheimer’s from Biogen. The FDA would have the authority to set parameters for post-marketing studies for drugs that receive fast-track approval, and it would have a clear path to revoke approvals if required studies do not proceed. Additionally, the agency would create an internal board to monitor its accelerated use of approval over time.

OTC hearing aids: The FDA is expected to issue a rule creating a regulatory framework for over-the-counter hearing aids within 30 days of the Senate bill taking effect. The senses. Elizabeth Warren (D-Mass.), Chuck Grassley (R-Iowa), Marsha Blackburn (R-Tenn.) and Maggie Hassan (DN.H.) introduced similar standalone legislation in April.

PFAS in cosmetics: A provision in the bill would require HHS to study per- and polyfluoroalkyl substances, or PFAS, which are so-called eternal chemicals because of their durability, in cosmetics. The department would have two years to report its findings on potential security risks.

And after: The HELP committee should meet on June 8 for the markup of the bill.

SCHRADER LOSES PRIMARY TO PROGRESSIVE CHALLENGER — Seven-term Democratic Rep. Kurt Schrader lost his Oregon primary to a progressive challenger, POLITICO’s Ally Mutnick writes, knocking yet another moderate party member off the slate as the Dems try to hold on to power in the room.

Schrader was among the trio of centrist Democrats who blocked the leadership’s plan to allow direct government negotiation of drug prices and another group that obstructed the party’s broader social spending agenda.

SHUREN: RETURN OF NON-COVID IVD PRE-SUBS — The FDA’s Center for Devices and Radiological Health plans to accept all pre-submissions of non-Covid-19 in vitro diagnostics, senior medical device regulator Jeff Shuren and director of the Office of Evaluation and Evaluation announced Tuesday. of the quality of William Maisel products.

“Due to the ongoing high COVID-related workload, it is likely that these IVD pre-submissions will initially be reviewed on an extended timeline,” Shuren and Maisel wrote in a blog post.

“We continue to receive nearly 120 EUA requests and pre-EUA submissions each month, the majority for in vitro diagnostic (IVD) testing, and we have begun receiving conventional submissions from companies intending to take their products beyond emergency use,” they added.

FTC, DOJ HOLDING PHARMA ANTITRUST ENFORCEMENT WORKSHOP — The Federal Trade Commission and the Department of Justice will host a two-day virtual workshop June 14-15 to examine “new approaches to enforcing antitrust laws in the pharmaceutical industry,” the FTC announced Tuesday.

“On the first day of the workshop, FTC Commissioner Rebecca Kelly Slaughter will deliver a keynote address, followed by plenary sessions on market concentration in the pharmaceutical sector and solutions to mergers,” the announcement reads. ‘agency. “Day two includes sessions on the innovation aspects of pharmaceutical mergers and how the conduct of pharmaceutical companies affects merger analysis.”

CMS ILL-EQUIPPED TO ENFORCE SAFETY RULES IN PANDEMIC — The Covid pandemic has brought to light a longstanding problem at the Centers for Medicare and Medicaid Services — the agency issues regulations but often doesn’t have the resources to enforce them, POLITICO’s Rachael Levy reports.

An example is CMS’s Covid vaccine requirement for healthcare workers. Up to a third of nurses are still unvaccinated at some facilities, and the agency says it has cited 69 hospitals for non-compliance. And while the agency controls much of the money that goes into the country’s health system, its reach on the ground is minimal, as current and former officials say it doesn’t have enough funds to monitor inspections.

MEDICARE TO LOWER 2023 PREMIUMS IN RESPONSE TO ADUHELM – On Friday, the Centers for Medicare and Medicaid Services announced they would reduce premiums for doctor-administered drugs in 2023, Katherine reports. The decision is the result of a report by CMS’s Office of the Actuary, which found the agency had overstated the cost of Biogen’s Alzheimer’s disease drug, Aduhelm. Premiums for 2022 were announced in the fall of 2021, and Biogen has since halved the average cost of Aduhelm for patients. CMS has chosen to cover the drug only for patients enrolled in certain clinical trials.

WHO URGES FOR A GLOBAL AUDIT OF SMALLPOX AND MONKEYPOX GUNS — The World Health Organization wants countries that have stockpiled doses of vaccines and treatments for smallpox and monkeypox to check their supplies and distribute them fairly where they are needed most, reports Helen Collis of POLITICO Europe. Smallpox countermeasures can help protect and treat patients with monkeypox, but the WHO does not know how many doses are available worldwide or how strong they are.

Ghana’s health system is already underfunded by global health aid, and it risks collapse if Covid-19 cases rise again, POLITICO’s Erin Banco reports from the field.

Pulse oximeters unable to accurately measure oxygen levels in people with darker skin have delayed Covid-19 treatments for black and Hispanic patients, STAT’s Usha Lee McFarling reports.