With Katherine Ellen Foley, Emily Martin, Ben Leonard, Alice Miranda Ollstein and Caitlin Oprysko.
— Advisers to federal regulators will discuss the safety of Covid-19 vaccines at two meetings this week.
— A bipartisan pair of lawmakers wants to make it easier for those who experience rare but serious side effects from Covid shots to receive compensation.
— A federal judge in Delaware gave drugmakers a small but potentially significant victory in their tussle with hospitals over the 340B drug discount program.
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VACCINE ADVISERS ZERO IN ON SAFETY — The CDC’s vaccine advisory committee meets Friday to go over the latest data on Covid vaccine safety, with a focus on cases of inflammatory heart conditions found in patients who received Pfizer or Moderna shots. The session follows an FDA advisory committee meeting last week about cases of myocarditis and pericarditis seen in a small number of patients — particularly those 30 and younger — who received either of the mRNA vaccines.
Health officials have emphasized that the cases are rare, none has resulted in death and they appear to clear up on their own. Still, the prevalence of the conditions among young people has raised concerns as vaccine manufacturers study inoculating more children against Covid. We’ll be looking out for what data is needed for scientists to establish a causal link between the mRNA shots and myocarditis, which Paul Offit, a member of FDA’s vaccine advisory panel, recently said he thinks exists.
Also on deck: The committee also will review how it plans to recommend booster vaccine doses, which are believed to be necessary to maintain adequate immunity, though it’s unclear when they’ll be needed. Like everything nowadays, it’s virtual.
On today’s schedule: HHS’ National Vaccine Advisory Committee meets today to cover much of the same territory on Covid vaccines. That panel will focus on safety, virus variants and field experience.
MEMBERS PROPOSE VACCINE INJURY SYSTEM OVERHAUL — A new bill, H.R. 3655 (117), by Reps. Lloyd Doggett (D-Texas) and Fred Upton (R-Mich.) would expedite the process for adding Covid vaccines to the Vaccine Injury Compensation Program, which is funded by industry to bolster vaccine confidence while protecting manufacturers from legal liability, once they’re fully approved by FDA. “Injury claims for Covid vaccines are now covered by an obscure HHS agency’s program that typically has a higher bar for claims,” POLITICO’s Susannah Luthi writes, and experts and regulators don’t know how the current system will work for people who are already vaccinated once the FDA licenses the shots.
The effort predates Covid shots’ entry into the market and is being targeted for inclusion in a broader vaccine development legislative package. Still, it’s unclear whether those who have already filed Covid vaccine injury claims could shift their complaints to the compensation program under the bill, and the debate demonstrates the fine line policymakers must walk between advocating for people injured by vaccines and dispelling hesitancy around their uptake.
US BUYS 200M MORE DOSES OF MODERNA’S COVID VACCINE — Moderna announced the government had purchased 200 million more doses of its Covid-19 vaccine to be distributed through the end of 2021 and beginning of 2022. In a press statement, CEO Stéphane Bancel alluded to the fact that more of these doses could be for initial vaccinations or booster shots for those with waning immunity. Moderna has been testing slightly updated versions of its vaccine’s protection on virus variants since January.
BY THE NUMBERS — Covid-19 has claimed the lives of more than 600,000 people in the United States.
REGENERON TO SEEK EUA EXPANSION FOR COVID THERAPY — Regeneron announced Wednesday that it plans to ask FDA to broaden the emergency use authorization for its Covid-19 antibody cocktail, after trial data showed it cuts the risk of death by 20 percent for patients who didn’t already have a natural antibody response compared to normal care. Regeneron plans to “immediately” share the data with regulators and petition them to extend use of the treatment to “appropriate” hospitalized patients, POLITICO’s Ben Leonard reports.
Remember when? Former President Donald Trump used the monoclonal antibody cocktail of casirivimab and imdevimab when he was hospitalized last year with Covid-19. Trump touted it as a “cure” in October before there was much data on its effectiveness.
VAPORS FROM HAND SANITIZERS CAN CAUSE SIDE EFFECTS, FDA WARNS — On Wednesday, FDA issued a notice that certain alcohol-based hand sanitizers can cause headaches, nausea or dizziness. These symptoms are usually minor, but the official caution comes from a general uptick in complaints the agency has received since the beginning of the pandemic. Best advice for users? Apply hand sanitizers in well-ventilated areas.
LABOR LAUNCHES NEW PUSH FOR DRUG PRICE BILL — A coalition of more than 100 labor unions, religious groups and health policy advocates Wednesday warned congressional committee chairs and Democratic leaders not to leave Medicare drug price negotiation, Medicare-at-50, and an expansion of benefits out of its larger jobs and families plans.
No House hearings or markups of drug pricing bill H.R. 3 have been scheduled since a group of Democratic moderates broadcast their concerns with the bill last month, and the Senate Finance Committee and Majority Leader Chuck Schumer’s office are still trying to find a proposal that can get at least 50 Democratic votes, lawmakers and aides told POLITICO’s Alice Miranda Ollstein.
A Senate staffer added that Finance Committee Democrats are trying to “update and bolster” the bipartisan bill that Finance Chair Ron Wyden (D-Ore.) and Chuck Grassley (R-Iowa) put forward last Congress and add some form of government price negotiation to it.
The state of play: Senate Budget Chair Bernie Sanders (I-Vt.) confirmed Wednesday that he is writing a budget resolution that includes Medicare drug price negotiation and the expansion of dental, hearing and vision benefits.
In the House, Budget Chair John Yarmuth (D-Ky.) confirmed Wednesday that he is working on a budget resolution with reconciliation instructions, aiming to have it completed by the August recess. While his office declined to say whether drug pricing language will be included, he noted the challenge of drafting something the entire caucus can agree on — especially after 10 Democrats already indicated their opposition to HR. 3.
But the Progressive Caucus wants to include that measure as well as other, more generous provisions. Rep. Pramila Jayapal (D-Wash.) on Wednesday called the budget resolution “a very important moment for progressives” and said that lowering the eligibility age of Medicare and expanding its benefits is “absolutely essential.”
PHARMA FLIES IN — Researchers from the world’s biggest drug companies held virtual meetings with Hill offices Tuesday as part of PhRMA’s annual fly-in. The researchers planned to focus on their companies’ work to end the pandemic and to “spotlight the industry’s unique role in advancing” research and development as behind-the-scenes wrangling continues on Democrats’ H.R. 3 — which the group staunchly opposes.
PUBLIC CITIZEN CALLS FOR REMOVAL OF WOODCOCK, CAVAZZONI, DUNN — Consumer advocacy group Public Citizen on Wednesday called on HHS Secretary Xavier Becerra to request the resignation or removal of top FDA drug regulators over the agency’s approval of Biogen’s Alzheimer’s disease treatment Aduhelm. Notably, the group wants career officials — CDER Director Patrizia Cavazzoni and Office of Neuroscience Director Billy Dunn — to be removed in addition to acting FDA Commissioner Janet Woodcock.
“You should direct the next Acting FDA Commissioner to consider whether the agency’s approval of Biogen’s BLA for aducanumab should be withdrawn,” Public Citizen’s Michael Carome wrote.
DRUGMAKERS SCORE POINTS IN LATEST 340B ROUND — AstraZeneca notched a small but potentially significant victory Wednesday in the pharmaceutical industry’s tussle with hospitals over the 340B drug discount program. A federal judge in Delaware refused to dismiss the company’s lawsuit against a Trump-era health agency advisory opinion, which said that manufacturers needed to pony up the program’s generous drug discounts to contract pharmacies, Susannah reports.
The opinion doesn’t close the case — and the judge has called for more briefing — but the judge stressed that the law establishing the 340B drug discount program does not mention contract pharmacies or direct pharma companies to extend the steep discounts to them as well as 340B hospitals.
Contract pharmacies that dispense the heavily discounted drugs on some hospitals’ behalf are a major point of contention for pharmaceutical companies, given their proliferation since the 340B program expanded under Obamacare. Last summer, some manufacturers began to stop extending the discounts, prompting the former top counsel for HHS to issue in December the advisory opinion at stake in this lawsuit.
MEDICAID GROUP URGES CONGRESS TO AMEND REBATE MINIMUMS — In what can only be described as uncanny timing (ahem, Aduhelm), the Medicaid and CHIP Payment and Access Commission recommended this week that lawmakers raise the minimum rebate percentage on drugs the FDA green-lights under the accelerated approval pathway. The increased percentage should apply until the drug receives traditional approval post-confirmatory trial, the group said.
ACLA PANS MEDPAC REPORT ON LAB FEE SCHEDULE — The American Clinical Laboratory Association on Wednesday pushed back on a MedPAC finding that private payers may not be able to negotiate lower prices for new, more expensive lab tests compared to routine tests, leading to increased Medicare costs down the line. ACLA President Julie Khani argued the “biased commentary” falls outside the group’s mandate from Congress.
“While the field of genetic testing is still nascent and changing rapidly, the lower average payment rate reductions (or payment rate increases) among such tests and their associated high rates of spending growth in recent years suggest that relying on private-payer rates alone will not control Medicare spending growth on these tests in the future,” MedPAC’s 2021 report to Congress states.
Myriad Genetics on Wednesday announced Thomas Slavin has been appointed its chief medical officer.
CUREVAC COVID SHOT POSTS LOW EFFICACY — German manufacturer CureVac’s Covid vaccine is just 47 percent effective against the illness, it announced Wednesday, falling well short of the rates of other shots already in use. While the vaccine is safe and its efficacy rate may improve with further analysis, the findings are a blow to the EU’s vaccine arsenal.
EU TO OPEN TRAVEL TO UNVACCINATED U.S. CITIZENS — Restrictions on travel to Europe from the United States are set to be eased after EU ambassadors reached an agreement on updating the approved travel list, POLITICO’s Mari Eccles reports.
Countries agreed to expand the list to include the U.S., North Macedonia, Serbia, Albania, Taiwan and Lebanon, with a formal sign-off expected at the end of the week. EU governments will gradually lift restrictions on non-essential travel from those countries, but can still impose certain conditions, such as quarantines or PCR tests, on travelers.
VACCINES TO BE MANDATORY FOR ENGLAND’S CARE WORKERS — Coronavirus vaccines will be mandatory for England’s care home staff, and the measure could be extended to all National Health Service workers, POLITICO’s Alex Wickham and Marina Adami report.
N.J. LAWMAKERS TAKE AIM AT INSULIN PRICE HIKES — New Jersey lawmakers are attempting to pass legislation that would require insulin manufacturers to issue annual cost reports to state regulators justifying price spikes, but the effort could draw the ire of the pharmaceutical lobbyists, POLITICO’s Sam Sutton writes.
The first attempt to produce industrial-scale quantities of the Pfizer vaccine was a failure, The Washington Post reports in a profile of the drugmaker’s efforts to stand up vaccine manufacturing capacity.
Harry Johns, the CEO of the Alzheimer’s Association, wants to stop talking about whether the FDA should have approved Aduhelm and instead focus on reducing the drug’s out-of-pocket cost, STAT News reports.
FDA on Tuesday announced it cleared another batch of J&J’s Covid-19 vaccine made at Emergent Biosolutions’ facility.
On Wednesday, a bipartisan team of senators reintroduced a bipartisan bill to curb antimicrobial resistance by working with industry and health care providers.