| | | | |  | | By Lauren Gardner, David Lim and Katherine Ellen Foley | Presented by The American Association of Kidney Patients (AAKP) | | | | — FDA is poised to green-light Covid-19 vaccines for babies and toddlers. Will regulators endorse Moderna's vaccines for older kids, too? — The Senate HELP Committee is set to mark up its FDA user fee reauthorization package today. — FDA granted marketing orders to the first disposable vapes, one of which has the highest nicotine concentration of any e-cigarette authorized for sale. It's Tuesday. Welcome to Prescription Pulse. Stay hydrated in this D.C. summer heat, readers. Send tips, feedback and sentient AI secrets 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 American Association of Kidney Patients (AAKP): Kidney disease affects an estimated 37 million Americans and disproportionately impacts individuals in black and brown communities across this country. The AAKP's fundamental purpose for advocating and representing the interests of kidney patients has improved treatments for those who suffer, but tremendous work remains to be done. A new FDA-approved treatment to alleviate some patient suffering is finally available, but CMS must make changes to ensure all patients have access. The time is now. | | | | | | | 
The wait for Covid-19 vaccines for little ones is almost over. | Joe Raedle/Getty Images | PEDIATRIC COVID VACCINES ON DECK — The FDA released briefing documents over the weekend that appeared largely favorable to Pfizer-BioNTech's and Moderna's efforts to offer vaccines to babies and toddlers , Lauren reports. The pandemic's uncertain trajectory coupled with higher hospitalization rates for the youngest kids compared with those 5 and older mean the vaccine "will likely have a beneficial effect on COVID-19-associated morbidity and mortality in this age group," FDA reviewers said of Pfizer's product. But those votes won't come until Wednesday. Today's daylong meeting will focus on Moderna's bid to vaccinate kids ages 6 through 17, which has traveled a long road due to a rare but concerning heart inflammation side effect most commonly seen in young males. The vaccine's association with rare cases of myocarditis and pericarditis, bolstered by international data, convinced the FDA not to move ahead with an emergency use authorization last fall, the agency said in its briefing document. But the FDA has signaled it might be ready to move beyond that posture. Analyses of U.S. data in active and passive surveillance systems conducted in the spring "do not support a difference in myocarditis/pericarditis risk for [Moderna] as compared to [Pfizer-BioNTech] or suggest a small difference because of uncertainties," the FDA said, calling evidence of a risk difference "inconclusive." What we're watching for: A long discussion about myocarditis risk and whether there's an effect on vaccine uptake by making another shot available for children 6 and older. BECERRA AGAIN TESTS POSITIVE — HHS Secretary Xavier Becerra tested positive for Covid on Monday , about a month after his first infection, POLITICO's Sarah Owermohle writes. He traveled to Los Angeles last week for the Summit of the Americas — as did Canadian Prime Minister Justin Trudeau, who also announced his second case of Covid on Monday.
| | | | A message from The American Association of Kidney Patients (AAKP):   | | | | | | TAKE TWO: SENATE HELP USER FEE MARKUP — The Senate HELP Committee is set to mark up its user fee reauthorization package today at 10 a.m. EDT. The meeting, originally scheduled for last week, was delayed after an agreement was not reached on a manager's amendment in time. POLITICO obtained a manager's amendment redline — dated from over the weekend — that will likely be offered to the legislative package today . The document suggests the committee is considering adding provisions that aim to strengthen the infant formula supply chain, make tweaks to drug importation, add reporting requirements on the FDA's mailroom, require the FDA to post periodic information technology strategic plans and more. Pack those snacks for a potentially lengthy hearing: A GOP HELP Committee aide told POLITICO Monday night that 52 amendments have been filed for the user fee package, including some "which may lead to a contentious markup."
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International air travelers no longer need to pass a Covid-19 test before flying to the U.S. | Charles Krupa/AP Photo | CDC ENDS INTERNATIONAL FLIGHT TESTING REQUIREMENT — The CDC on Friday eliminated pre-departure Covid testing requirements for all international air travelers entering the U.S. as of midnight Sunday, ending one of the last pandemic-related travel restrictions still in place, POLITICO's Oriana Pawlyk reports. The CDC decided that "based on the science and data," it was time to lift the restriction, a senior administration official said, adding it remains open to reinstatement should new variants of concern circulate. The agency formally published the notice on Monday in the Federal Register. The public health sector signaled support for the decision. "I was never convinced it was adding any real protection," said Scott Becker, CEO of the Association of Public Health Laboratories. FTC PHARMA ANTITRUST ENFORCEMENT WORKSHOP KICKING OFF — The Federal Trade Commission and the Department of Justice are convening a two-day workshop today to discuss antitrust enforcement in the pharmaceutical industry. FTC Commissioner Rebecca Kelly Slaughter is delivering a keynote address at 9:15 EDT.
| | | FDA APPROVES FIRST ALOPECIA TREATMENT — The FDA approved Olumiant, a drug from Eli Lilly, to treat severe alopecia on Monday . This is the first treatment for the condition, which affects more than 300,000 people in the U.S, that targets the signaling pathway which leads the body to attack its own hair follicles. In late-stage clinical trials, participants who received a daily 4-milligram dose of Olumiant regrew significant amounts of their scalp hair, eyebrows and eyelashes after 36 weeks compared with those who received 2 mg daily or a placebo. The FDA initially approved Olumiant in 2018 to treat moderate-to-severe rheumatoid arthritis. In May, the agency approved the drug to treat Covid-19 for some hospitalized patients.
| | | FDA CLEARS FIRST DISPOSABLE ELECTRONIC CIGARETTES FOR MARKET — On Friday, the FDA granted marketing orders to two disposable vapes from NJOY , Katherine reports. The products, called the Daily Rich Tobacco and Extra Rich Tobacco, both resemble cigarettes and taste like tobacco. The latter contains 6 percent nicotine, the highest amount in any vapor product authorized to date. In the same decision, the FDA denied other flavors of NJOY's Daily and is still reviewing the menthol-flavored version of the product.
| | | HEALTH CANADA APPROVES ALS DRUG FROM AMYLYX — Canada's health authority approved Albrioza, a drug to treat amyotrophic lateral sclerosis from Amylyx Pharmaceuticals, on Monday. Health Canada is the first country to approve the drug based on data from Phase II trials. The U.S. FDA is still reviewing Amylyx's drug data, although in March, its independent advisory committee voted that the Phase II data didn't demonstrate whether the drug treated the disease. The FDA has until Sept. 29 to make its final decision, which will consider additional data. JOHN NKENGASONG TO SERVE AS U.S. GLOBAL AIDS COORDINATOR — On Monday, John Nkengasong, the former head of the Africa Centres for Disease Control and Prevention, stepped into the role of U.S. Global AIDS Coordinator and Special Representative for Global Health Diplomacy, POLITICO's Carmen Paun reports. Nkengasong will coordinate the $7 billion initiative geared at providing HIV treatments to more than 50 countries, known as the President's Emergency Plan for AIDS Relief. PEPFAR has been leaderless since 2020 when former head Deborah Birx stepped down to serve as the White House coronavirus response coordinator.
| | | Maddie Davidson is now director of government affairs at Regeneron Pharmaceuticals. She most recently was health policy director for Sen. Mike Braun (R-Ind.).
| | | MENTHOL CIG BANS MAY NOT LOWER CIG SMOKING RATES — A newly published study by researchers at Georgetown University, the University of Illinois at Chicago, the University of Michigan School of Public Health and Georgia State University's School of Public Policy Studies showed that the ban of menthol cigarettes in Poland wasn't associated with any substantial decrease in cigarette consumption. The study, published in the European Journal of Public Health , tracked cigarette sales in Poland from May 2018 through April 2021; the country, along with the rest of the European Union, banned menthol cigarettes in May 2020. In Poland, menthol cigarettes made up roughly 28 percent of all cigarette sales before the ban. After the ban, however, cigarette sales didn't fall significantly, indicating that smokers switched to non-menthol cigarettes. The study also notes that cigarette manufacturers have found other ways to provide menthol flavoring to consumers, such as including flavored menthol packaging for cigarettes.
| | | For POLITICO magazine, Mona Zhang and Paul Demko chronicle the woes of Beau Wrigley of the chewing gum empire in his attempt to pivot to weed. The Biden administration will pursue regulations to lower allowable nicotine levels in cigarettes to non-addictive levels, Jennifer Maloney reports for The Wall Street Journal. Health officials across the country struggle to communicate monkeypox risks without alienating men who have sex with men, writes Fenit Nirappil in The Washington Post.
| | A message from The American Association of Kidney Patients (AAKP): Kidney disease has an incredibly alarming and growing impact on Americans and their families, and a disproportionate impact across minority communities, with black Americans being four times more likely to suffer from kidney failure than their white peers. This means a need for kidney replacement therapy, such as regular dialysis treatments, which are often linked to miserable side effects, including itching under the skin. This condition, called Chronic Kidney Disease-associated Pruritis (CKD-aP), affects 30-70% of kidney patients and has been associated with poor quality of life, poor sleep, depression, and an increased risk of infection, hospitalization, and death. No FDA-approved treatment has been available until recently, but doctors aren't ready to offer this treatment to their Medicare patients until there is long-term coverage from CMS. This is a health equity issue with a clear solution. Learn more and help ensure all Americans have choice and access to available treatment options. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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