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MENTHOL MEETING BLITZ — Between today and Jan. 11, the White House’s Office of Information and Regulatory Affairs has 72 meetings scheduled with trade organizations and public health advocacy groups to discuss the FDA’s forthcoming rules that would ban menthol cigarettes and flavored cigars, according to the office’s public calendar. The office has had nearly a dozen meetings on the rules so far this month.
The busy schedule comes as the White House conducts its final review of the proposed rules, which the FDA has been working on for more than a decade. The agency first estimated the rules would be finalized in August, but at last month’s Food and Drug Law Institute meeting on tobacco policy, Center for Tobacco Products Director Brian King said he anticipated the FDA would be on track to finish by the end of the year.
Public health groups want to see the rules finalized as soon as possible because of their projected impact on tobacco use. By one FDA estimate, if current menthol smokers were to quit, the menthol ban would save more than 600,000 lives by 2060.
Some groups worry that menthol cigarettes appeal to minors, too. “Our goal is to reiterate just how urgent and timely it is that these regulations be put forward,” Meredith Berkman, co-founder of Parents Against Vaping e-cigarettes, or PAVe, told Prescription Pulse. The advocacy group has a meeting with OMB later this week.
Other groups are concerned about the bans’ unintended consequences. John Boyd Jr., president of the National Black Farmers Association, said he’s worried the rules will disproportionately harm Black tobacco farmers due to decreased demand for their crops — and leave smokers with a dearth of alternatives. Most Black smokers prefer menthol cigarettes.
“I do not want the ban to go forward,” said Boyd, who met with the White House earlier this month. “It hurts African Americans, it hurts African American farmers, and it doesn’t do anything to help us.”
Still, even with 75 OIRA meetings, including with retailer and gas station owner groups, it’s unlikely finalizing the bans will be halted. “Because you have a meeting schedule, doesn’t mean [the White House has] to take your meeting,” Desmond Jenson, the deputy director of the commercial tobacco control program at the Public Health Law Center, told Prescription Pulse.
IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Flu activity is picking up, according to the CDC’s weekly Influenza Surveillance Report.
Send news and tips to Lauren Gardner ([email protected] or @Gardner_LM), David Lim ([email protected] or @davidalim) and Katherine Ellen Foley ([email protected] or @katherineefoley).
TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with POLITICO policy reporter Arek Sarkissian about an abortion rights initiative in Florida whose organizers haven’t yet been able to gather enough signatures to qualify for the ballot — and the potential for the Sunshine State to become the exception for abortion-rights supporters.
E&C HEALTH SUB READIES MARKUP — The House Energy and Commerce Health Subcommittee is set to mark up a series of 21 bills on Wednesday.
The list of bills — which remained fluid Monday — includes policies that impact pharmacy benefit managers and provider payment and coverage policies in Medicare. Only two or three are not expected to be bipartisan, though how bipartisan the other bills will be remains up in the air.
“Our health care sector continues to find new innovative treatments — yet seniors on Medicare can be left without access to the best care,” E&C Chair Cathy McMorris Rodgers (R-Wash.) and E&C Health Subcommittee Chair Brett Guthrie (R-Ky.) said in a statement. “Further, Congress must continue working on proposals that ensure Medicare beneficiaries can receive physician care and laboratory testing services where they live.”
One bill that will likely draw some Democratic opposition is a legislative effort to codify four years of transitional Medicare reimbursement for breakthrough-designated medical devices that gain FDA marketing authorization.
E&C ranking member Frank Pallone (D-N.J.) expressed concern during recent hearings that Medicare bills under review by committee Republicans are too expensive and not paid for.
FDA FUNDING WATCH — Speaker Mike Johnson (R-La.) is pushing to have the House vote on his two-tiered stopgap spending plan before midnight — a plan that will likely have to win Democrat support with a handful of conservative Republicans already opposing the effort.
The FDA, which receives taxpayer funds in the Agriculture-FDA bill, is more resilient than many agencies because approximately half of its medical product staff is funded through its user fee program.
The Senate is moving to prepare its own government funding package — but top senators are still waiting to see how Johnson’s plan shakes out before moving forward.
GLOBAL SEQUENCING ACCESS PUSHED — On Monday, genomic diagnostic company Illumina launched a Global Health Access Initiative in an effort to increase the use of sequencing instruments and laboratory materials in low- and middle-income countries. Genomic sequencing can be used to detect changes in emerging infectious diseases.
“We know that enabling countries to perform pathogen sequencing locally strengthens health systems, enables better preparedness and empowers countries to manage their priority health threats,” Vanessa Moeder, head of global health at Illumina, said in a statement. “It also avoids costly and time-consuming shipment of samples abroad and leads to faster response times.”
SANDOZ UPS DRUG PRODUCTION — Generic drug manufacturer Sandoz said it has opened two new manufacturing plants in Germany and Austria. The Austrian plant, supported in part by the Austrian government, will focus on producing the active ingredient in penicillin. The German plant, supported partly by the state government of Bavaria, will develop biosimilars. Sandoz declined to specify which biosimilars it will target.
Health insurance trade lobby AHIP said that Pat Geraghty, president and CEO of GuideWell and Florida Blue, will become chair of its board effective Jan. 1. Christopher Palmieri, president and CEO of the Commonwealth Care Alliance, is also joining the group’s board.
House Republicans plan to slash 95 percent of the budget for former President Trump’s Ending the HIV Epidemic in the U.S. Initiative, POLITICO’s Evan Peng reports.
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