|
Presented by The Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy. | | | | |  | | By David Lim, Lauren Gardner and Katherine Ellen Foley | Presented by The Pharmaceutical Care Management Association | | | | — FDA narrows the authorized use of the Johnson & Johnson Covid-19 vaccine amid blood-clotting concerns. — The House Energy and Commerce Committee unveiled its legislative package to reauthorize FDA’s medical product user fee programs. — The proliferation of antibiotic prescriptions written during Covid waves raises concerns about how the practice could fuel antimicrobial resistance. It’s Friday. Welcome back to Prescription Pulse. Check out Lauren on Vox’s Today, Explained podcast talking about why it’s taken so long for kids under 5 to get Covid-19 vaccines. Send your vote, 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).
| | | | A message from The Pharmaceutical Care Management Association: In the fight to make prescription drugs more affordable, PBMs are the only part of the prescription drug supply and payment chain dedicated to lowering drug costs for patients. In fact, PBMs are lowering patient prescription drug costs by nearly $1,000 every year, enabling safe and seamless prescription drug delivery to patients, and helping patients stay on their medications.
Get the full story and learn more about how PBMs advocate for patients at OnYourRxSide.org. | | | | | | | 
FDA late Thursday limited use of the Johnson & Johnson Covid-19 vaccine because of a potential, but rare, risk of blood clots. | Mary Altaffer/AP Photo | FDA LIMITS J&J COVID VACCINE USE AMID BLOOD-CLOTTING CONCERNS — FDA has restricted the use of the Johnson & Johnson Covid-19 vaccine to adults unable or unwilling to get the Pfizer-BioNTech or Moderna mRNA shots, Lauren and Katherine report. The decision comes after the agency completed an updated risk analysis of developing thrombosis with thrombocytopenia syndrome, or TTS, a rare and possibly fatal combination of blood clots and low platelet counts that can occur one to two weeks after receiving the vaccine. What does it mean? The vaccine is still available under emergency use authorization, and the CDC has already made a preferential recommendation for the mRNA vaccines over J&J’s. But a former senior FDA official said Thursday’s move essentially makes FDA’s position official that the J&J shot ranks third among the Covid vaccine options. “If there were no mRNA vaccines available, this is still a very viable option. It can save lives,” a Biden administration official said. “But in places where there is an abundance of mRNA vaccines, like the U.S., the benefit-risk profile changes because there’s other options.” FDA UPDATES PRESCRIBING GUIDELINES FOR PAXLOVID — FDA has developed a new checklist and updated fact sheet for health care providers wishing to prescribe Paxlovid, the Covid-19 antiviral from Pfizer, Katherine reports. Those new tools should be used to help screen patients and make sure that any other drug they take won’t interact with the antiviral. Paxlovid is authorized under emergency use for those at a high risk of developing severe Covid-19, including people who are vaccinated. But logistical challenges have made it difficult for patients to obtain it within five days of their symptom onset. The Biden administration said it’s working on other initiatives that could make it easier for patients to get the drug, including increasing the number of pharmacies that carry it. “There is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent Covid-19 symptoms following completion of a treatment course,” John Farley, director of the Center for Drug Evaluation and Research’s Office of Infectious Diseases, said in a Q&A published by FDA on Wednesday.
| | | | SUBSCRIBE TO NATIONAL SECURITY DAILY : Keep up with the latest critical developments from Ukraine and across Europe in our daily newsletter, National Security Daily. The Russian invasion of Ukraine could disrupt the established world order and result in a refugee crisis, increased cyberattacks, rising energy costs and additional disruption to global supply chains. Go inside the top national security and foreign-policymaking shops for insight on the global threats faced by the U.S. and its allies and what actions world leaders are taking to address them. Subscribe today. | | | | | | | | HOUSE E&C COMMITTEE REVEAL THE FOOD AND DRUG AMENDMENTS OF 2022 — Lawmakers on the House Energy and Commerce Committee released bipartisan legislation that would reauthorize FDA medical product user fee programs for another five years, David and Katherine report. Congress must periodically reauthorize the programs to continue to allow FDA to collect fees from the medical product manufacturers, which it uses to hire staff to review product applications more expeditiously. User fees reauthorization is generally considered must-pass legislation, which gives lawmakers the opportunity to attach other legislative priorities. Each week, we’ll bring you a deeper dive into one of the policies. Advanced manufacturing: One policy rider would require the agency to establish a pilot program through 2029 for sponsors wishing to bring to market products that use advanced manufacturing — an umbrella term for a novel way of making a cleaner, faster or higher-quality product. Per the House legislation , the pilot program would require FDA to work quickly with sponsors of a product made with advanced manufacturing and expedite the review process. The language around the specific review timeline requirements within the program appears intentionally vague, which would allow the agency to decide those details.
| | | ANTIBIOTIC USE TO TREAT COVID HEIGHTENS AMR CONCERNS — The White House push last week to ensure that doctors prescribe antiviral treatments for Covid-19 patients contained a concerning footnote: The CDC has found that many physicians are handing out antibiotics to those sick with the virus. The pandemic has amplified the ongoing problem of overprescribing antibiotics, a practice that can feed into antimicrobial resistance, or AMR, Lauren writes. The prospect of pathogens morphing over time to no longer respond to medicines threatens the practice of modern medicine, WHO warns. While bacterial infections can occur alongside Covid infections, antibiotics should be reserved only for outpatient cases in which it’s clear they’d benefit the patient, federal guidelines say. CDC’s Office of Antibiotic Stewardship works to educate both patients and providers on the cons of overusing antibiotics, and officials plan to keep monitoring the volume of antibiotics dispensed in the U.S. as Covid waves come and go. For Covid cases, experts say prescribers need to get comfortable doling out the new antiviral pill regimens — and recognizing, as one pharmacist said, that viruses “are a bigger cause of infection than we give them credit for.”
| | | | 
With more barriers to reproductive health expected, advocates are urging FDA to approve OTC birth control. | AP Photo | DRAFT SCOTUS OPINION SPURS FRESH URGENCY ON OTC BIRTH CONTROL — The prospect of the Supreme Court overturning federal protections for abortion is renewing a sense of urgency for advocates of making oral contraceptives available over-the-counter, Lauren writes. The yearslong effort is expected to produce one formal application to FDA later this year, with another company poised to follow in the coming years. Once FDA has an application in hand, it has 10 months to make a call on whether to move the prescription in question over the counter. But with decades of safety data on the drugs — and more barriers to reproductive health expected to crop up in the states — proponents of OTC birth control say FDA shouldn’t delay in endorsing this first-in-class switch once it can. FDA CRACKS DOWN ON HEMP COMPANIES ADVERTISING DELTA-8 THC PRODUCTS — FDA sent five warning letters to hemp product manufacturers for selling delta-8 THC and claiming they have medicinal properties, POLITICO’s Mona Zhang reports. Products with delta-8 THC are generally produced by combining CBD with an acid, a solvent and heat, which converts the compound into delta-8 THC. FDA warned companies that it had not reviewed the safety and efficacy of the products, that it has and had received adverse reports from these products. The agency also said the products are marketed in a way that could appeal to children.
| | | | 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. | | | | | | | | BIOGEN NIXES CEO AND MOST ADUHELM PROGRAMS — Biogen will replace its chief executive officer and all but eliminate its remaining support for Aduhelm , a contentious drug for Alzheimer’s disease, Katherine reports. The company decided to diminish the size of its Aduhelm program after the Centers for Medicare and Medicaid Services limited the drug’s coverage to those enrolled in certain clinical trials. “This decision effectively denies all Medicare beneficiaries access to Aduhelm,” said outgoing CEO Michel Vounatsos. The move will save the company an extra $500 million annually, though support for the drug will still be available for those in ongoing or planned studies.
| | | ResMed announced Thursday Jim Hollingshead, president of sleep and respiratory care, is departing the company for another job. COO Rob Douglas is stepping into the role on an interim basis. Insulet announced Thursday that CEO Shacey Petrovic will step down from the top executive job on June 1 “for personal family reasons.” Hollingshead will become Insulet’s new president and CEO.
| | | | A message from The Pharmaceutical Care Management Association:   | | | | | | Recent Bose layoffs targeted the company’s health division working on hearing aid development, The Boston Globe’s Anissa Gardizy reports. The Covid-19 pandemic has killed nearly 15 million people globally, the World Health Organization said Thursday, POLITICO’s Carmen Paun reports. Researchers discovered that the organ given to the first person to receive a heart transplant from a pig had an animal virus, but it is unclear whether it played a role in the person’s death, The Associated Press’ Lauran Neergaard reports. World Trade Organization officials are circulating a draft proposal to temporarily waive certain intellectual property protections for Covid-19 vaccines, POLITICO’s Andrew Green, Carmen Paun and Daniel Payne report.
| | | The FDA is holding a meeting of its Pharmacy Compounding Advisory Committee on June 8 to discuss its 503A bulks list. Minutes from industry-FDA Medical Device User Fee Amendments negotiations through March 15, 2022, were posted by the agency earlier this week. FDA published draft guidance Wednesday containing considerations for conducting human radiolabeled mass balance studies of investigational drugs. FDA published draft guidance this week containing recommendations for participants in its medical device Voluntary Improvement Program. FDA issued final guidance this week outlining recommendations for companies conducting early feasibility studies of medical devices for patients living with type 2 diabetes mellitus.
| | | | A message from The Pharmaceutical Care Management Association: Pharmacy Benefit Managers, PBMs, are working on behalf of 266 million Americans with health insurance to reduce prescription drug costs, expand access to medications, and improve patient outcomes.
Here are the key facts to know about PBMs:
· PBMs negotiate with drug companies to lower prescription drug costs, reducing patient drug costs by nearly $1,000 each year.
· PBMs work with pharmacies to deliver prescription drugs to patients safely and seamlessly.
· PBMs help patients stay on their prescription drugs to live healthier lives.
· PBMs advocate for patients in the fight to keep prescription drugs accessible and affordable.
Learn how PBMs advocate for patients at OnYourRxSide.org. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |  |
