| | | | |  | | By Lauren Gardner, Katherine Ellen Foley and David Lim | Presented by the Pharmaceutical Care Management Association | With help from Megan R. Wilson
| | | — The Senate parliamentarian will hear arguments over Democrats' plan to allow Medicare to negotiate drug prices. But how would the provisions affect drugmakers? — The CDC's advisers will meet today to discuss Novavax's Covid-19 vaccine. — The FDA says that synthetic nicotine vapes with the greatest risk to youth are a high priority for review. It's Tuesday. Welcome to Prescription Pulse. Are you MOSHU, the adorable red panda residing at the Oregon Zoo? Thank you for brightening our day. 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 the Pharmaceutical Care Management Association: PBMs are working to lower patient costs for insulin. But the INSULIN Act will increase insulin costs while giving drug manufacturers another way to game the system to maximize profits. Drug manufacturers alone set insulin prices. Rather than increasing pharma's profits, Congress should take on drug companies by addressing the root cause of high insulin costs: their price setting.
PBMs support reducing insulin costs for patients. Learn more about PBM efforts to lower insulin costs. | | | | | | | 
Democrats want Medicare to have the ability to negotiate drug prices. | Brendan Smialowski/AFP/Getty Images | RECONCILING WHAT DRUG PRICING MEANS FOR PHARMA — All eyes are on the Senate this week as lawmakers battle over the piece of Democrats' reconciliation bill that's still standing as of now : An effort to lower some drug prices that Medicare pays. The Senate parliamentarian is expected to hear arguments Thursday on Democrats' plan to allow Medicare to negotiate drug prices as part of the office's review to ensure the legislation complies with the Byrd rule, a chamber aide told POLITICO's Alice Miranda Ollstein. That will determine whether Democrats can pass the provisions with 51 votes instead of the usual 60. Meanwhile, Republicans are preparing their own procedural attacks on the already slimmed-down measure, POLITICO's Caitlin Emma and Jennifer Scholtes write. What does this mean for pharma? Politically, getting language blessed by both the Senate parliamentarian and West Virginia Democrat Joe Manchin and passed through Congress would be a win for Democrats heading into the midterms since it would hand the party a legislative win before what are most likely to be next month's ugly inflation figures. But an analyst says what's not in the bill could be a big win for industry. "There will be savings to the government on one side of the ledger, but the pharmaceutical companies have a path to make up that revenue loss by just increasing launch prices, and there's nothing in this bill that limits that," said Chris Meekins, a former HHS and Hill adviser who's now a health policy analyst at Raymond James. That means drug companies could still set high prices when a drug enters the market, taking into account limited returns in later years once the drug is subject to Medicare negotiation, he said. Lawmakers have introduced bills in the past to address high drug-launch prices, Meekins said, so the absence of any mention of them in the reconciliation language likely means not enough Democrats would support such a change. "There seems to be hesitation to do anything that could limit innovation of new products, which is what action related to launch prices would do," he said.
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The CDC's advisory committee meets today to consider whether Novavax's Covid-19 vaccine should be approved for adults who haven't been immunized. | Carsten Koall/Getty Images | CDC ADVISERS TO DISCUSS NOVAVAX VACCINE — The Centers for Disease Control and Prevention's external advisory committee will meet today to discuss Novavax's Covid-19 vaccine for adults who haven't yet been immunized. The vaccine, authorized by the Food and Drug Administration last week, was more than 90 percent effective in clinical trials and contains a version of the coronavirus spike protein made with moth cells. It's an older technology than what's used in the Pfizer-BioNTech and Moderna vaccines, which Novavax executives hope will appeal to the roughly 10 percent of U.S. adults who remain unvaccinated. The meeting, scheduled to begin at 10 a.m. EDT time today, will include an update on the number of myocarditis and pericarditis cases resulting from vaccination. It will also include a discussion of clinical considerations for administering the shot, which consists of two injections three weeks apart. After the advisers meet today, CDC director Rochelle Walensky will issue a final say on whether to recommend the vaccine. Typically, the director follows her committee's decision, though she doesn't have to. The Biden administration has already purchased 3.2 million doses of Novavax's vaccine. FAUCI REFLECTS ON LEGACY, PLOTS RETIREMENT — Anthony Fauci, President Joe Biden's chief medical adviser who became a household name during the two-and-a-half years of the Covid-19 pandemic, plans to retire from government by the end of Biden's term, POLITICO's Sarah Owermohle scoops. Fauci also acknowledged that Covid is here to stay and said he thinks we'll need "a once-a-year boost, like flu." Speaking of boosters: Administration officials acknowledged last week that they're considering opening up second booster shots to all U.S. adults while stressing two seemingly contradictory points: It's up to the FDA and the CDC to make that call, but getting a booster of the original vaccine formulation won't preclude getting an Omicron-specific shot when it debuts later this year. "Why would we not do this with an Omicron-specific booster?" said Walid Gellad, director of the University of Pittsburgh's Center for Pharmaceutical Policy and Prescribing, pointing to FDA's advisers considering the data favorable to an Omicron-tailored formulation just last month. He also expressed concern about the CDC's history of not highlighting the nuances of the benefit-risk balance of boosting a 40-something with the ancestral strain compared to an 18-year-old man who falls into the myocarditis-risk category. Related reading: Kaiser Health News has an overview of the burning question at hand: "Boost Now or Wait?"
| | | | A message from the Pharmaceutical Care Management Association:   | | | | | | FDA GIVES A (NON) UPDATE ON SYNTHETIC NICOTINE VAPE ENFORCEMENT — After the FDA's Center for Tobacco Products announced it had sent warning letters to synthetic vape manufacturers selling products without submitting marketing applications, Katherine wondered: What about all the other vapes with synthetic nicotine? Without marketing orders, they're technically illegal — but will the agency pull them from the market? In a statement to POLITICO, the agency did not say whether it would specifically use its enforcement discretion — a tactic by which the agency looks the other way on vape sales while it continues to review their marketing applications. However, the FDA hinted that some products may be a higher priority for review than others. "Addressing products with large market share that pose the greatest risk to youth is … of high importance," the agency said in the statement. A word on menthol cigarettes: Responding to a separate inquiry, the agency said it didn't have a definitive date on when it would be ready to finalize the rules banning menthol cigarettes and flavored cigars, but that "once the comment periods close in early August, the FDA intends to move carefully and quickly in considering all public comments received and determining next steps to protect public health." | | | CDC: DEMAND OUTSTRIPS SUPPLY FOR MONKEYPOX VACCINE — The supply of Jynneos' monkeypox vaccine is not keeping up with demand in the U.S., POLITICO's Krista Mahr reports. "I want to acknowledge that at this time the demand for vaccines from jurisdictions is higher than our current available supply, and we know that this is frustrating," CDC Director Rochelle Walensky said during a Friday media briefing. "We anticipate an increase in cases in the coming weeks." HHS, which oversees the Strategic National Stockpile, said it had so far distributed about 156,000 doses of Jynneos, the two-dose FDA-approved monkeypox vaccine, and another 131,000 doses are available. LAST COMMERCIAL LAB STANDS UP MONKEYPOX TESTING — The CDC announced Monday that Sonic Healthcare is starting to test for monkeypox using the agency's orthopoxvirus test. The company — which will conduct testing at its Austin, Texas, lab — is the last of the five commercial labs tapped by the CDC to broaden U.S. testing capacity. Nationwide, labs can conduct up to 80,000 tests per week, according to the CDC.
| | | Marta Sokolowska is being tapped as the FDA's Center for Drug Evaluation and Research deputy center director for substance use and behavioral health. Chad Patterson will be iRhythm's new chief commercial officer.
| | | MEDICINE ABORTION MANUFACTURER TURNS TO K STREET — GenBioPro, the Nevada-based maker of one of the drugs used in medication abortions, has hired Emergent Strategies as its first lobbying representative, Megan writes. The firm is working on abortion access "issues related to FDA Approval of Mifepristone," according to a disclosure form recently filed to the Senate. Scott Eckart and Meghan O'Hara, the account's two lobbyists, did not respond to requests for comment about the work. Companies file REMS proposal: GenBioPro and Danco Laboratories, which makes the branded drug Mifeprex, submitted a joint response to the FDA last month regarding possible modifications to the drug's Risk Evaluation and Mitigation Strategy, a Danco spokesperson confirmed. As required, the submission focused on the certification process for pharmacies that would dispense the branded and generic drugs. OBAMA TO SPEAK AT ILLUMINA GENOMICS FORUM — Genomic sequencing company Illumina announced Monday former President Barack Obama will speak on Sept. 28 at its inaugural Illumina Genomics Forum.
| | | STAT's Bob Herman, Kate Sheridan, J. Emory Parker, Adam Feuerstein and Mohana Ravindranath explore the compensation top health care CEOs received in 2021.
| | | The White House Office of Information and Regulatory Affairs is reviewing an economically significant final rule to establish a regulatory pathway for over-the-counter hearing aids. It is also reviewing a final guidance on hearing-aid devices and personal sound-amplification products. On Friday, a group of 181 House lawmakers sent a letter to HHS Secretary Xavier Becerra asking for the department and its Office of the Inspector General "to use current statutory authority to impose civil monetary penalties against all drug manufacturers who have unlawfully overcharged" 340B hospitals. Top House lawmakers, including House Energy and Commerce Health Subcommittee Chair Anna Eshoo (D-Calif.), wrote to the FDA on Friday, asking whether the agency can use a process similar to its approach to rapid approval for oncology treatments for amyotrophic lateral sclerosis drugs.
| | | | A message from the Pharmaceutical Care Management Association: America's pharmacy benefit managers (PBMs) support lower insulin costs, and have taken steps to reduce out-of-pocket costs for patients relying on insulin.
The INSULIN Act won't lower insulin costs. It gives Big Pharma companies another way to game the system to maximize profits. Rather than lining pharma's pockets, Congress should take on manufacturers to reduce costs: increasing competition among insulin manufacturers and stopping patent abuses that block generic and biosimilar insulins from reaching the market for patients to use.
It's simple. Insulin prices are high because there are only a few insulin manufacturers, shielded from competition, and those companies set and raise prices. PBMs, on the other hand, are the only entity in the prescription drug supply and payment chain dedicated to reducing drug costs. On average, PBMs reduce patient drug costs by nearly $1,000 every year.
Learn more about how PBMs are working to lower insulin costs. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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