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Pfizer and other drugmakers are facing calls from Congress to make their opioid reversal drugs available over the counter, a move lawmakers claim will reduce stigmas around addiction and drug-related deaths.
Thirty lawmakers in the House and Senate are prodding Pfizer, Teva Pharmaceuticals, Hikma, Emergent Biosolutions, Amphastar Pharmaceuticals, and Adamis Pharmaceuticals to apply to the Food and Drug Administration for over-the-counter status of their respective naloxone products.
The requests come in letters sent to the drugmakers, with Sens. Joe Manchin (D-W.Va.), Elizabeth Warren (D-Mass.), and Lisa Murkowski (R-Alaska) and Reps. Alexandria Ocasio-Cortez (D-N.Y.), Rashida Tlaib (D-Mich.), and Brian Fitzpatrick (R-Pa.) among the ideologically diverse group of signers.
Both Congress and the Biden administration have ramped up efforts to combat rising overdose numbers in the U.S. Overdose numbers soared to historic highs through the Covid-19 pandemic, according to data from the Centers for Disease Control and Prevention. The pandemic “has dramatically exacerbated the opioid and substance use disorder epidemic in this country, with reported overdoses and deaths spiking to historic levels,” the lawmakers said in the letters.
“It has never been more important to adopt opioid overdose prevention and reversal strategies on a wide scale,” they said. This includes “steps to increase access to affordable naloxone, which is a proven, effective tool to reduce medical emergencies, drug overdoses, and deaths.” Naloxone has been a particular focus in calls to battle addiction. In November, the White House’s Office of National Drug Control Policy provided a road map for states to ease access to the reversal drug.
Emergent spokesman Matt Hartwig said the company is “reviewing the letter” and looks forward to “engaging in this important discussion.” Adamis’ CEO, Dennis Carlo, said it believes that “broadening access to naloxone products is a critical step to combat the overdose epidemic” and that it’s “committed and eager to work with Congress, states, and other agencies.” Pfizer confirmed receipt of the letter but declined to comment. Read more from Ian Lopez.
Medicare’s Alzheimer’s Drug Plan Falls Short on Diversity Access
Racial minorities and others disproportionately affected by Alzheimer’s disease could continue facing barriers to treatment unless Medicare does more to facilitate access to research and safety studies, policy watchers say. The Centers for Medicare & Medicaid Services’ finalized plan for Biogen’s Aduhelm restricts coverage to patients enrolled in certain clinical trials.
CMS says approved studies have to include a diverse group of patients representative of the national diagnosed population. But patient advocates say it doesn’t clarify how trial organizers can combat geographic, financial, and safety barriers to participation. Such vulnerable patients are “the ones that are going to experience the brunt of a bad decision first” without an agency ensuring the drug actually works for them, said Reshma Ramachandran, a fellow at Yale University’s National Clinician Scholars Program.
The CMS made multiple changes to its initial coverage determination in response to trial access concerns from patient advocacy groups. The agency removed the requirement that approved clinical trials take place at hospital-based outpatient centers, as well as exclusion criteria that would have prevented patients with Down syndrome from participating.
But hospital-based centers may be the only places with the medical research teams needed to conduct these trials, even though some minority and rural populations may not live near these sites or have the resources to travel there. The coverage plan also doesn’t push researchers to conduct preliminary safety studies for Down syndrome patients—which is needed before including them in larger efficacy trials.
Policy watchers say the CMS could reimburse patients for the time and travel needed to participate in these trials, and also clarify to trial sponsors when additional safety data is needed on specific populations. The agency could also require that CMS-approved comparative studies using patient health databases meet certain diversity benchmarks. Celine Castronuovo has more.
- Separately, a senior CMS official said last week’s decision to restrict Medicare coverage for Alzheimer’s drugs that are fast-tracked through the FDA doesn’t portend changes in other disease areas. “Our recent decision should not be viewed as setting a new direction on therapies that receive FDA accelerated approval,” Lee Fleisher, chief medical officer for CMS, said Tuesday. Several biotech companies and investors wondered whether the move to cap coverage for Biogen’s Aduhelm had signaled a higher bar for Medicare reimbursement. Read more from John Tozzi.
What Else to Know Today
CDC Panel to Meet April 20 on Boosters: A CDC panel of outside scientific advisers will meet next week to discuss and likely vote on Covid-19 booster recommendations. The April 20 meeting comes two weeks after a corresponding committee within the Food and Drug Administration had a general discussion—but no formal recommendation—on administering another round of booster shots if they become necessary this fall. Both agencies already cleared a second round of Covid-19 booster doses made by Pfizer-BioNtech or Moderna, for adults 50 and up or anyone 12 and up with weak immunity. Jeannie Baumann has more.
Oklahoma Bans Abortion, Providers Could Be Jailed: The governor of Oklahoma signed a law Tuesday outlawing abortion and subjecting medical providers to as many as 10 years in prison and a maximum fine of $100,000 for performing the procedure. “I promised Oklahoma that I would sign every pro-life bill that hit my desk and that’s what we’re doing here today,” Gov. Kevin Stitt (R) said at a signing ceremony on Tuesday. Oklahoma’s law will however allow abortions performed to save the life of the mother. Additionally, the law won’t authorize criminal charges against the mother. Read more from Vincent Del Giudice.
- In the wake of increasingly restrictive abortion laws across the U.S., Yelp is the latest company to cover travel costs for employees who need to leave their home states to get reproductive care. The company has nearly 4,000 workers in the U.S. and around 200 in Texas, where another bill has prohibited abortions after six weeks. Yelp will offer its benefit through the company’s insurance provider starting next month, a person familiar with the matter said. It will also extend that coverage to dependents. Read more from Kelsey Butler.
Court Drops Air Ambulance’s Suit Against Medicare Insurer: An air ambulance service lost its suit to collect higher payments for transporting two Medicare Advantage patients because it didn’t ask a federal agency to review the claim’s partial denial first, the Ninth Circuit ruled. A provider contesting its Medicare reimbursements has to exhaust administrative remedies before filing suit in court, even when the payments are provided under a Medicare Advantage plan offered by a private insurer, the U.S. Court of Appeals for the Ninth Circuit said. Read more from Mary Anne Pazanowski.
N.J. Hospital Faces Negligence Fight on Unlicensed Worker: A New Jersey medical center must answer a suit seeking to hold it vicariously liable for a radiology technician’s alleged negligence despite the patient’s failure to follow a special procedural rule for professional malpractice cases, the state’s high court said. State law requires filing an affidavit of merit attesting to the validity of a claim for professional malpractice, but it doesn’t apply to a lawsuit filed against a medical facility to recover for injuries allegedly caused by an unlicensed employee, the New Jersey Supreme Court said. Read more from Pazanowski.
Editor’s Note: BGOV’s Health Care Briefing will not publish for the remainder of the congressional recess through April 22. Publication will resume Monday, April 25.
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