Driving The Day
INADVERTENT CONSEQUENCES? As Washington takes a summer hiatus, the debate around the FDA’s forthcoming ban on menthol cigarettes heats up.
The finalized ban, tentatively scheduled to drop later this month, has been in the works for nearly 15 years — though it could be delayed. The FDA’s goal is to encourage smokers of the cooling, minty cigarettes, most of whom are Black, to quit smoking. But some fear the ban could cause unintended harm to the Black community.
“The police look for entryways into searches and to look for more serious crimes,” said Sonia Pruitt, a retired police captain who served with the Montgomery County Police Department in Maryland for nearly 30 years.
Speaking at a press briefing Thursday by the National Coalition of Justice Practitioners and the National Newspapers Publishers Association, she added that aggressive officers, regardless of their intention, “will approach people — particularly Black people … and ask questions to investigate whether the cigarettes they are smoking are legal,” which could lead to dangerous interactions with law enforcement.
Supporters of the ban, including 32 members of the Congressional Black Caucus, note that the FDA’s rule wouldn’t apply to enforcement of individuals — only manufacturers and retailers.
“There’s not been one person arrested for possession of a menthol cigarette,” Phillip Gardiner, co-chair of the African American Tobacco Control Leadership Council, told Prescription Pulse. Gardiner noted that California and Massachusetts have banned menthol cigarettes and hundreds of localities have greatly restricted their sales with success.
AATCLC sued the FDA in 2020 with anti-smoking advocacy group Action on Smoking and Health over the agency’s failure to take action on banning menthol cigarettes. The lawsuit was dismissed after the FDA began the rulemaking process, but Gardiner said if the FDA fails to finalize the ban this month, the groups are ready to return to court.
There’s one area advocates can agree on: More culturally appropriate smoking cessation support for those trying to quit is needed.
“You do not legislate your way into a solution in which what you’re basically doing is creating laws to control an addiction,” said David Daniels III, a retired lieutenant from the Bridgeport Police Department in Connecticut who served for more than 25 years.
IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Will we see you at the National Book Festival this weekend?
Send news, tips and your favorite reads to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) and Katherine Ellen Foley ([email protected] or @katherineefoley).
TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with POLITICO’s White House correspondent Adam Cancryn about the millions of Medicaid beneficiaries being dropped from the program as a result of the expiration of a pandemic policy meant to prevent vulnerable people from losing their health coverage — and how this change comes at the worst time for President Joe Biden.
In the Courts
SCOTUS BLOCKS PURDUE PHARMA SETTLEMENT — Supreme Court justices heeded a request from the Biden administration Thursday to temporarily block a $6 billion nationwide bankruptcy settlement with OxyContin maker Purdue Pharma that includes payouts for those harmed by opioids.
The proposed settlement would have protected Sackler family members who own the company from civil lawsuits. Instead, the court said it would hear arguments in December about whether bankruptcy law offers this kind of immunity.
Drug Pricing
PhRMA SEEKS SUMMARY JUDGMENT — The largest brand-name pharmaceutical industry lobby late Thursday requested summary judgment in its lawsuit seeking to overturn the government’s planned Medicare price negotiations, arguing its member companies are being harmed as CMS readies release of the first 10 drugs it will negotiate.
PhRMA’s lawsuit claims the government negotiating drug prices violates the Fifth and Eighth Amendments of the Constitution by constraining industry’s ability to seek review of pricing decisions and imposing a large excise tax if drugmakers decline to participate. The request for summary judgment also argues that the government program “violates the separation of powers and the nondelegation doctrine.”
The litigation is one of several lawsuits attempting to stop CMS from launching negotiations later this year for the first 10 Part D drugs. The agency is slated to announce the list of brand drugs selected by Sept. 1.
Kelly Bagby, a vice president at AARP Foundation Litigation, told reporters on Thursday that the older adult advocacy group plans to defend the government’s authority to negotiate the price of drugs in court.
“We are anticipating filing as many amicus briefs as necessary,” Bagby said. “We believe that the law is entirely appropriate and is necessary,” she added.
AARP SPOTLIGHTS PART D DRUG PRICE HIKES — AARP’s policy arm also released a report Thursday that emphasized the downward pressure on Medicare drug prices the Inflation Reduction Act’s inflation rebates will create.
The analysis, which examined list price increases for the top 25 Medicare Part D drugs in 2021, found that they had price hikes of an average 226 percent since the drugs entered the market. However, prescription drug costs have increased at a slower rate than the pace of inflation in recent years.
“The long-term impact of the new inflation-based rebates remains to be seen,” the AARP report said. “However, given the magnitude of lifetime price changes seen among many popular brand-name drugs, even a small movement in the right direction will result in a substantial improvement over the status quo.”
Public Health
KEEP AN EYE ON RESPIRATORY VIRUS SEASON — State public health officials this week said they’re preparing for an active fall and winter with Covid-19, influenza and respiratory syncytial virus all circulating. But the officials are not anticipating hospitals to be overwhelmed with patients as in recent years.
For the first time, vaccines will be available for all three illnesses, with RSV shots newly approved for adults ages 60 and older; another targeted at pregnant people could win FDA approval later this month.
The lingering question is when older Americans eligible for all three should get the shots. Covid has yet to fall into a seasonal pattern, and the updated vaccine formulations aren’t expected to be available until late September. Meanwhile, some data suggests that giving the RSV shot at the same time as another vaccine could diminish its effectiveness.
While spacing the vaccines may be the ideal approach, “having all three together is possible,” said Dr. Manisha Juthani, commissioner of the Connecticut Department of Public Health. “I think what we really want to see is that people have some level of protection going into this season.”
Industry Intel
ADVAMED: CMS NEEDS MORE RESOURCES — The largest medical device lobby said Thursday that CMS’ Coverage and Analysis Group needs more money so it can more rapidly determine whether Medicare should cover new medical technologies.
“FDA has done a good job over the years of working to ensure it has the resources and staff at appropriate levels to keep pace with the medtech industry’s efforts to meet patient needs, particularly in the wake of the most recent [Medical Device User Fee Amendments],” AdvaMed CEO Scott Whitaker said. “However, when it comes to getting these approved devices covered under Medicare, CMS lacks the necessary resources to keep up.”
WEGOVY MAKER PRIORITIZES EXISTING PATIENTS — The Danish drug company Novo Nordisk said Thursday that amid heightened demand and a manufacturing pause for its weight loss drug Wegovy, it will prioritize getting doses to those who have already begun taking the drug, POLITICO’s Helen Collis reports.
Pharma Moves
Mike Loftus, director of hospital pharmacy for the Mercy Health System in St. Louis, and Dr. Adrian Moran, chief medical officer at Aurora St. Luke’s Medical Center in Milwaukee, have joined the 340B Health Board of Directors.
Document Drawer
The FDA issued draft guidance outlining the process for formal meetings between the agency and biosimilar sponsors and applicants. It also issued draft guidance containing recommendations for classification categories for biosimilar approval supplements.
The FDA issued draft guidance on how it thinks sponsors can obtain data on groups of people historically underrepresented in clinical trials in postmarket settings and how the agency can require or request information on safety and effectiveness.
