Biden stumps for drug pricing measures in social spending bill

By David Lim and Katherine Ellen Foley

Presented by Biogen

— President Joe Biden stumped for drug pricing efforts in an effort to garner Senate support for his Build Back Better plan.

— With FDA poised to authorize the first at-home treatment for Covid, health experts ask: Who should get it, and how?

— FDA cautioned a PCR test made by Tide Laboratories might not work against the Omicron variant.

It’s Tuesday. Welcome back to Prescription Pulse. We’re curious about the implications of a paper suggesting Viagra use is tied to a decreased risk of developing Alzheimer’s disease.

Send 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 Biogen:

Having lost several family members to Alzheimer’s disease—including both of his parents, a grandfather, and an uncle—Greg understands from firsthand experience what his own diagnosis meant for both him and his family. Though his own life has changed dramatically, Greg has hope for future generations and others who are living with Alzheimer’s. Learn more about Greg’s story and Biogen’s commitment to those living with Alzheimer’s.

BIDEN STUMPS FOR DEM DRUG PRICING LEGISLATION — President Joe Biden pushed Democrat senators on Monday to support his Build Back Better plan, citing drug pricing measures he argued are needed to curb what patients pay for medicines.

The package — which passed the House and is now awaiting consideration in a Senate distracted by a looming debt ceiling and the need to pass the National Defense Authorization Act — contains provisions that would give Medicare the power to bargain on the price of a handful of the most expensive drugs; penalize drugmakers who raise prices faster than inflation for people, whether on public or private insurance; and cap out-of-pocket costs for insulin at $35 a month.

“Everyone has less money in their pockets because high drug costs make health insurance more expensive for everyone,” Biden said in a speech at the White House.

The Senate parliamentarian Monday started a review of the bill’s health provisions to see whether they can pass under the chamber’s strict rules for bringing up bills for a simple-majority vote. Meanwhile, the Pharmaceutical Research and Manufacturers of America is lobbying lawmakers to oppose the measures, which they argue would impede access to treatments.

“A damaging bill jammed through a partisan process will not provide patients struggling to afford their medicines meaningful relief,” PhRMA CEO Stephen Ubl said in a statement. “The bill inserts the heavy hand of government into America’s medicine cabinet.”

Lobbyists for drugmakers, pharmacists and large employers are pointing fingers at pharmacy benefit managers, arguing they are responsible for climbing drug costs , POLITICO’s Megan R. Wilson reports.

While there is little agreement among PBM opponents about what actions Congress should take, industry lobbyists are offering a menu of options for Democrats to consider, such as requiring PBMs to pass on more of the rebates they negotiate with drugmakers to consumers or employers. They could also ban a common practice called spread pricing, in which PBMs charge health plans more than they pay to the pharmacy dispensing a drug and pocket the difference.

PBMs have responded with their own lobbying and advertising blitz and insist they’re being scapegoated.

JC Scott, who leads the Pharmaceutical Care Management Association, the trade group for PBMs, said targeting his members might be good politics and take the focus off drugmakers during a critical moment in the debate, but it would not lower drug costs.

“There is this sentiment around some stakeholders that they believe, ‘Well, gee, if one part of the drug supply chain is going to be impacted by this legislation, then the PBM industry needs to give its pound of flesh as well,’” Scott said.

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OMICRON COMPLICATES PUZZLE OVER AT-HOME COVID PILL — FDA is poised to authorize the first at-home Covid-19 treatment, but some experts fear access and safety issues will prevent it from having a big impact on the pandemic, Lauren and Katherine report.

Representatives from Merck, who make the drug with Ridgeback Biotherapeutics, said they have reason to believe molnupiravir will work against the Omicron variant, which has already appeared in several states. Given its inevitable spread, eyes are on the agency’s next steps.

Even if FDA authorizes the Merck-Ridgeback Biotherapeutics pill, doctors and other providers will be on the hook for making judgment calls on whether to prescribe the pill — and do it within five days of a patient showing symptoms — to realize the potential benefits.

“It will probably end up being a quite limited subset of individuals who even qualify [for the drug],” Leana Wen, an emergency physician and public health professor at George Washington University, told us. Molnupiravir was tested in only unvaccinated adults with at least one condition that would put them at risk of hospitalization for Covid. Compared to a placebo, it lowered the hospitalization risk by about 30 percent.

Notably, it wasn’t tested in pregnant individuals, although they are at an elevated risk of developing severe Covid. In animal studies, molnupiravir led to miscarriages or birth defects. Advisers to the agency hotly debated whether the drug should be available for anyone pregnant and nursing because of these risks.

FDA’s authorization will specify who it sees as “high-risk” populations; other advisory groups, including professional societies like the American College of Obstetricians and Gynecologists, will likely also issue guidance on who should or shouldn’t receive the pill. These guidelines aren’t binding, but many providers adhere to them.

Speaking of providers: For all the concern about who should get molnupiravir, other experts are worried about the cumbersome hoops patients would have to jump through to even obtain it. Pharmacists are waiting to see whether the Centers for Medicare and Medicaid Services would compensate them for their time evaluating patients and distributing the drug; if they couldn’t, patients would have to make an appointment with a primary care provider, which could take precious time. Many patients also don’t have a general practitioner, so they would wind up in urgent care settings or the emergency room anyway.

Short supply: Labeling and access issues aside, it’s not clear that supply would be large enough to really put a dent in hospitalizations. The federal government has ordered 3.1 million courses of treatment to be rolled out between authorization and early 2022, with the possibility of ordering 2 million more. But estimates from the Centers for Disease Control and Prevention suggest that more than 99 million adults still haven’t received a single vaccine dose. The supply of molnupiravir is “a drop in the bucket,” says Eunice Neeley, a preventive medicine specialist and primary care provider based in New Orleans, Louisiana.

Down the line, Wen and others believe this could lead to hoarding of the drug, too. “I would imagine that there would be pressure on physicians to prescribe this pill to patients who don't even have Covid,” Wen told your RxP authors.

WHO RECOMMENDS CEASING CONVALESCENT PLASMA USE FOR COVID — The World Health Organization Monday advised against using a transfusion of blood plasma from people who recovered from Covid-19 to treat patients with the disease, POLITICO’s Carmen Paun reports.

“Despite its initial promise, current evidence shows that it does not improve survival nor reduce the need for mechanical ventilation, and it is costly and time-consuming to administer,” the world health body said.

An FDA spokesperson declined to comment on the WHO announcement but noted that the authorization for convalescent plasma for Covid-19 remains in effect in the U.S.

FDA: TIDE LABORATORIES TEST EXPECTED TO FAIL AGAINST OMICRON VARIANT — FDA on Monday cautioned that a PCR test made by Tide Laboratories is expected to fail against the Omicron variant because it targets an impacted part of the N-gene. The test is “not believed to be used for high volume testing,” according to FDA. See a list of labs where FDA says the test is being used.

FDA AUTHORIZES MONOCLONAL ANTIBODIES FOR CHILDREN WITH COVID — The agency Friday expanded the use of Eli Lilly’s monoclonal antibodies bamlanivimab and etesevimab to include all children, including newborns, at high risk of developing severe disease.

LAWMAKERS SEND YET ANOTHER LETTER TO FDA ASKING FOR E-CIG UPDATE — Rep. Raja Krishnamoorthi (D-Ill.), the chair of the House Subcommittee on Economic and Consumer Policy, and Rep. Michael Cloud (R-Texas), ranking member, asked FDA for another update on e-cigarette marketing applications Monday. In a letter addressed to acting FDA Commissioner Janet Woodcock, the two lawmakers stated that even with weekly briefings to the subcommittee, the agency still hasn’t indicated an intent to rule on four of the five largest e-cigarette manufacturers in the near future. They asked the agency to submit the steps it has taken on each application by no later than Dec. 20.

MERCK PAUSES ENROLLMENT IN LATE-STAGE HIV PROPHYLAXIS TRIAL — At the recommendation of an external monitoring committee, Merck stopped taking in new participants to its Phase III trial on an HIV pre-exposure prophylaxis medication. Participants already enrolled will continue receiving the drug, and the company will conduct interim analyses on the data collected so far. It will also screen participants more frequently for indications that they have HIV, but it has not said why it stopped the trial.

DRAFT GUIDANCE ON DRUG REVIEW SIGNALS FDA FOCUS ON PUBLIC HEALTH — FDA’s draft guidance on the benefit-risk assessments of drugs and biologics reflects the agency’s broader commitment to public health, argue Peter Lurie, the president and executive director of the Center for Science in the Public Interest, and Joshua Sharfstein, the vice dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health and former principal deputy commissioner at FDA in a recent commentary in JAMA. The agency stated that its assessment of therapeutics would consider those beyond the target population for a drug, including “risks related to misuse, accidental exposure or disease transmission.” This commitment, the authors argue, could change the way the agency regulates antibiotics, vaccines and tobacco products.

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Dec. 8: The CMS Innovation Center holds a roundtable on its health equity strategy at 1:30 p.m. EST.

Dec. 14: FDA holds a webinar on recent regulations outlining its De Novo classification process at 1 p.m. EST.

DE BLASIO ANNOUNCES SWEEPING VACCINE REQUIREMENT — All New York City private-sector workers will be required to be vaccinated against Covid-19 under a newly announced regulation that kicks in Dec. 27, outgoing Mayor Bill de Blasio announced Monday. The mandate will apply to about 184,000 businesses — every private firm with more than one employee. It will apply to all in-person workers but not to those who work remotely.

POLITICO’s Sally Goldenberg and Erin Durkin report the city is also requiring children between ages 5 and 11 to show proof of at least one dose before entering restaurants, theaters and gyms starting on Dec. 14.

U.S. ANNOUNCES EXPANSION OF GLOBAL VACCINATION EFFORT — The U.S. Agency for International Development — which manages the Initiative for Global Vaccine Access — said Monday it will dedicate $315 million to vaccine delivery in low- and middle-income countries, $10 million to local vaccine manufacturing and $75 million to the USAID’s Rapid Response Surge Support, Carmen reports.

Endpoints News’ Zachary Brennan previewed FDA’s negative briefing documents on Reata Pharmaceuticals’ potential kidney drug ahead of its Wednesday advisory committee meeting.

A message from Biogen:

When Greg received the devastating news that he had been diagnosed with Alzheimer’s, he thought about his family members whom he’d watched grapple with the disease. Stunned yet not surprised by the news, Greg’s first concern was his children. Like all of those living with Alzheimer’s or supporting someone with the disease, Greg’s life changed dramatically as a result of his diagnosis. Despite his own challenges, Greg says caregivers are “the real all stars.” As those who have been impacted by the disease know all too well, Alzheimer’s affects not only the patient, but often has implications for and takes a toll on loved ones. Biogen is learning from those who came before us and listening to patients and caregivers in order to pioneer new advances in neuroscience that bring hope to future generations. Learn more about Greg’s story and Biogen’s commitment to those living with Alzheimer’s.

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