| | | | |  | | By Lauren Gardner, Katherine Ellen Foley and David Lim | | | | — Two federal programs that compensate people who suffer injuries from vaccines or pandemic treatments face so many claims that patients are waiting years for potential payouts. — The Senate HELP committee introduced a bill that would reauthorize FDA's medical product user fee programs. — The Federal Trade Commission and the Department of Justice announced a workshop on enforcing antitrust laws in pharma. It's Wednesday. Welcome back to Prescription Pulse. Happy Pride Month, readers! Send tips and feedback to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).
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Federal compensation for injuries incurred from vaccines of all kinds is being held up because of an overwhelming number of claims. | Rajesh Kumar Singh/AP Photo | VAX INJURY PROGRAMS OVERWHELMED AS REFORM STALLS — The two federal programs intended to compensate people injured by vaccines or pandemic countermeasures are fielding thousands of claims unlikely to be resolved — or paid out — anytime soon, Lauren reports. The Countermeasures Injury Compensation Program, which currently covers Covid-19 vaccines and treatments, has received more than 8,000 complaints in the two-plus years since the disease surfaced compared with the 500 it had received since the 2009–2010 H1N1 flu pandemic. Patient advocates and attorneys 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 Program, which covers nearly three times as many vaccines today 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 moving through Congress this year — lawmakers have failed to act. Absent any changes, those who work on the issue fear the optics of an overrun system could fuel vaccine hesitancy if the public mistakes the situation as too many injuries flooding the program, when its coverage area has grown 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's sponsored two bills to overhaul the VICP. KFF: VACCINE MISINFO MAINTAINS GRIP ON PREGNANT PEOPLE — Pregnancy-related misinformation around Covid-19 vaccines persists despite efforts by federal health officials to encourage immunizations for those who are pregnant, a recently released Kaiser Family Foundation poll finds. Nearly 30 percent of women who are pregnant or who plan to become pregnant believe at least one piece of misinformation about the shots and pregnancy, the group found, with items ranging from a recommendation against pregnant people getting vaccinated to a belief that the vaccines cause infertility. About one-third of the respondents said they had heard the false statements KFF asked about and didn't know whether they were true, meaning more than six in 10 adults either believe or are unsure about such misinformation.
| | | | STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today. | | | | | | | | SENATE HELP LEADERS INTRODUCE FDA USER FEES BILL — On Friday, Senate HELP Committee members introduced the bill that would reauthorize the human medical product user fee programs for FDA. "This bipartisan bill marks an important step in building off those successful partnerships to ensure FDA's review and approval process remains nimble and forward-looking for the next generation of medical products, treatments and cures," ranking member Richard Burr (R-N.C.), who introduced the text with Chair Patty Murray (D-Wash.), said in a statement. The bill, called the FDA Safety and Landmark Advancements Act, contains a smattering of changes compared with the legislation's discussion draftput forward in May. Accelerated approval: Like the House user fee bill, the Senate bill strengthens the agency's authority around the 0approval pathway responsible for drugs like Aduhelm, the contentious Alzheimer's drug from Biogen. FDA would have the authority to set parameters for post-marketing studies for drugs that receive accelerated approval, and it would have a clear pathway for revoking approvals if the required studies don't pan out. Additionally, the agency would create an internal council to monitor its accelerated approval use over time. OTC hearing aids: FDA would have to issue a rule creating a regulatory framework for over-the-counter hearing aids within 30 days of the Senate bill becoming law. Sens. Elizabeth Warren (D-Mass.), Chuck Grassley (R-Iowa), Marsha Blackburn (R-Tenn.) and Maggie Hassan (D-N.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 forever chemicals because of their durability, in cosmetics. The department would have two years to report its findings on potential safety risks. What's next: The HELP committee is expected to meet on June 8 for the bill's markup. SCHRADER LOSES PRIMARY TO PROGRESSIVE CHALLENGER — Seven-term Democratic Rep. Kurt Schraderhas lost his primary in Oregon to a progressive challenger , POLITICO's Ally Mutnick writes, knocking yet another moderate party member off the roster as Dems try to hold onto power in the chamber. Schrader was part of the trio of centrist Democrats who blocked leadership's plan to allow direct government negotiation of drug prices and another group that stymied the party's broader social spending package.
| | | SHUREN: NON-COVID IVD PRE-SUBS RETURNING — FDA's Center for Devices and Radiological Health plans to accept all non-Covid-19 in-vitro diagnostics pre-submissions, top medical device regulator Jeff Shuren and Office of Product Evaluation and Quality director William Maisel announced Tuesday. "Due to the continued elevated workload related to COVID, it's likely these IVD pre-submissions will initially be reviewed under 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) tests, and we have begun receiving conventional submissions from firms intending to transition their products beyond emergency use," they added.
| | | FTC, DOJ HOLDING PHARMA ANTITRUST ENFORCEMENT WORKSHOP — The Federal Trade Commission and the Department of Justice will hold a virtual two-day workshop on June 14–15 to examine "new approaches to enforcing the 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 merger remedies," the agency's announcement states. "The second day features sessions on the innovation aspects of pharmaceutical mergers and how conduct by pharmaceutical companies affects merger analysis." CMS ILL-EQUIPPED TO ENFORCE PANDEMIC SAFETY RULES — The Covid pandemic has shined a light on a longtime issue 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. One example is CMS' Covid vaccine requirement for health care workers. As many as one-third of nurses remain unvaccinated at some facilities, and the agency says it's cited 69 hospitals for noncompliance. And while the agency controls much of the money that goes into the nation's health care system, its reach on the ground is minimal, as current and former officials say it doesn't have enough funding to keep up with inspections. MEDICARE TO LOWER 2023 PREMIUMS IN RESPONSE TO ADUHELM — On Friday, the Centers for Medicare and Medicaid Services announced it will lower the premiums for doctor-administered drugs in 2023 , Katherine reports. The decision is a result of a report from the CMS Office of the Actuary, which found that the agency overestimated the cost of Biogen's Alzheimer's drug, Aduhelm. Premiums for 2022 were announced in fall 2021, and Biogen has since halved the average cost of Aduhelm for patients. CMS has opted to cover the drug only for patients enrolled in certain clinical trials.
| | | WHO URGES GLOBAL AUDIT OF SMALLPOX, MONKEYPOX SHOTS — The World Health Organization wants countries that have stockpiled doses of smallpox and monkeypox vaccines and treatments to audit their supplies and dole them out fairly where they're needed most, POLITICO Europe's Helen Collis reports. Smallpox countermeasures may help protect and treat monkeypox patients, but the WHO doesn't know how many doses are available worldwide or how potent they are.
| | | The Ghanaian health care system is already underfunded by global health aid, and it risks collapsing if Covid-19 cases spike once more, POLITICO's Erin Banco reports from the ground. Pulse oximeters incapable of accurately measuring oxygen levels in people with darker skin delayed Covid-19 treatments for Black and Hispanic patients, STAT's Usha Lee McFarling reports.
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