| | | | |  | | By Lauren Gardner and David Lim | Presented by Idorsia Pharmaceuticals | With Megan R. Wilson
| | |  A lawsuit sparked by doctors who objected to a tongue-in-cheek tweet by the FDA about using the horse drug Ivermectin to treat Covid continues to play out in the court system. | Ted S. Warren/AP | REINING IN FDA SPEECH — The FDA’s pandemic-era admonitions to Americans clamoring for an anti-parasitic drug to treat Covid-19 continue to spell legal trouble for an agency eager to tamp down misinformation. Conservative commentators hyped ivermectin, sold as a paste for horses and livestock and as tablets for humans, at the pandemic’s height as a viable Covid treatment, spurring some people to self-medicate with the veterinary formulation. Three doctors sued the FDA over the tweet in question — plus other online statements — arguing the agency overstepped its authority into the practice of medicine, conflating the drug’s animal version with the one approved for human use, studies of which haven’t shown it to be safe and effective against the virus. A federal district court previously ruled that the doctors couldn’t challenge the agency over statements that weren’t considered final agency actions, but the conservative Fifth Circuit Court of Appeals overturned that call, sending the case back to be decided on the merits. A chilling effect: Briefing in the lawsuit’s latest iteration wrapped up last week, and former FDA officials and legal experts worry that the case could give the agency pause when determining how to effectively communicate public safety concerns. The challenge could make the FDA less comfortable leveraging the pithy, direct-to-consumer access of social media when trying to amplify its public messages. “Strategically, I would not be surprised if FDA picks its battles,” said Lisa Dwyer, a partner at King & Spalding and former FDA deputy chief of staff. The FDA and the DOJ declined to comment. Still effective: It’s worth noting, though, that the FDA’s ivermectin message was effective. The “you are not a horse” tweet — which predates the platform’s transition to X — has been reposted more than 67,000 times and received more than 106,000 likes. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Is anyone else extra sneezy this week but not sick, or is it just your lead author? Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).
| | | | A message from Idorsia Pharmaceuticals: Chronic insomnia can wreak havoc on one’s mental and physical health. Many insomnia patients are living in limbo, as previous medications did not work, but their ability to access newer treatments is restricted. Learn more. | | | | | | | 
Drugmakers, PBMs and other companies and trade associations have released their lobbying spending disclosures for the fourth quarter of 2023. | Karen Bleier/AFP via Getty Images | LOBBYING SPENDING NUMBERS ROLL IN — Lobbying spending for some of the top drugmakers appears to have dipped or stagnated last year compared with 2022, according to a preliminary analysis of lobbying disclosure forms by Megan. While much of the industry was reeling from the passage of the Inflation Reduction Act, which mandated government drug price negotiations, other players had fresh issues in the advocacy portfolio, such as pushing for Medicare coverage of new weight-loss drugs like Zepbound. Elsewhere in the pharmaceutical chain, some pharmacy benefit managers upped their lobbying spending in 2023 as bipartisan lawmakers in Congress moved bills that would impose new transparency requirements on them and force changes to how they do business. Companies and trade associations had until midnight on Monday to submit fourth-quarter disclosures for 2023, so look for Megan to suss out the year’s trends and add to the list of the biggest spenders. Here's a first look at some of the 2023 numbers compared with 2022 spending: — The drugmaker trade group Pharmaceutical Research and Manufacturers of America spent nearly $28.1 million on lobbying vs. $28.3 million. — The Pharmaceutical Care Management Association, which reps PBMs, spent more than $15.4 million vs. about $8.7 million. — Pfizer spent more than $14.1 million vs. $13.6 million. — CVS Health spent nearly $11.8 million vs. almost $10.6 million. — Amgen spent more than $10.5 million vs. $10.1 million. — Merck spent almost $10 million vs. $8.3 million. — Genentech spent $9.6 million vs. nearly $8.8 million. — Bristol Myers Squibb spent about $8.9 million vs. $5.4 million. — Eli Lilly spent roughly $7.9 million in 2023 vs. $6.8 million. — Bayer spent almost $7.4 million vs. nearly $6 million.
| | | | JOIN 1/31 FOR A TALK ON THE RACE TO SOLVE ALZHEIMER’S: Breakthrough drugs and treatments are giving new hope for slowing neurodegenerative diseases like Alzheimer’s disease and ALS. But if that progress slows, the societal and economic cost to the U.S. could be high. Join POLITICO, alongside lawmakers, official and experts, on Jan. 31 to discuss a path forward for better collaboration among health systems, industry and government. REGISTER HERE. | | | | | WHERE IS OTC BIRTH CONTROL? An over-the-counter birth control pill is expected to launch early this year, but exactly when is still a mystery. A spokesperson for Perrigo, the company behind the drug, confirmed it’s still targeting a market debut by the end of the first quarter. As part of the Biden administration’s push to highlight reproductive choice ahead of the 2024 race for the White House, HHS said Monday that it and the departments of Labor and Treasury “continue to consider” comments received concerning insurance coverage of preventive OTC products available without cost-sharing or a prescription. The administration also released guidance Monday — on what would have been the 51st anniversary of Roe v. Wade — requiring insurers to cover more contraceptives at no cost under the Affordable Care Act.
| | | | A message from Idorsia Pharmaceuticals:   | | | | | AWAITING FEBRUARY — Washington is awaiting the next step in the implementation of the first Medicare drug price negotiations: CMS is mandated to send its initial offers to the manufacturers of the opening slate of drugs selected for the program by Feb. 1. What we know: CMS must send a “concise justification” to each company of the initial maximum fair price for a selected drug. What we don’t know: It is uncertain whether drugmakers might choose to make public the initial offers from CMS. What’s next: Each manufacturer will then have 30 days to accept the proposed price or make a counteroffer. If the companies choose to counter, CMS will hold up to three negotiation meetings during the spring and summer if the agency does not accept it. On Aug. 1, the negotiation period ends, and by Sept. 1, the government will publish the final drug prices in the first negotiations. Those prices will take effect in 2026.
| | | | Enter the “room where it happens”, where global power players shape policy and politics, with Power Play. POLITICO’s brand-new podcast will host conversations with the leaders and power players shaping the biggest ideas and driving the global conversations, moderated by award-winning journalist Anne McElvoy. Sign up today to be notified of new episodes – click here. | | | | | | | | | PRETERM BIRTH POST-MAKENA — The FDA and the Duke-Margolis Center for Health Policy will convene a two-day meeting today on advancing drug development to prevent preterm birth in the aftermath of Makena being pulled from the market last year. The workshop aims “to promote discussion and collaboration between researchers, clinicians, industry, parents, and regulators on considerations for advancing drug development for the prevention of” spontaneous preterm birth, according to a discussion guide published ahead of the event. To recap: Independent FDA advisers recommended in 2022 that the agency pull Makena, an injection marketed as lowering the risk of preterm birth, from the market after recent data showed it wasn’t effective at preventing delivery before 35 weeks of pregnancy or lowering the risk of adverse conditions in premature babies. The drug had won accelerated approval from the agency in 2011, but its manufacturer took several years to complete the confirmatory trial that convinced the FDA to back withdrawal. Unmet need: About 10 percent of infants born in the U.S. each year are premature, or born before 37 weeks of pregnancy, and are at increased risk of physical and developmental problems. The cause of spontaneous preterm births isn’t well understood, but the phenomenon disproportionately affects Black mothers. Latest science: Newly published research by the University of California, San Francisco, found that pregnant people with high levels of mutations in certain genes, like those linked to involuntary muscle contraction, were less likely to respond to Makena. That discovery could encourage a precision-medicine approach to preventing preterm birth, researchers said.
| | | | A message from Idorsia Pharmaceuticals: Chronic insomnia can wreak havoc on one’s mental and physical health. Many insomnia patients are living in limbo, as previous medications did not work, but their ability to access newer treatments is restricted. These newer medications, known as dual orexin receptor antagonists, or DORAs, block the binding of the wake-promoting neuropeptides orexins and turn down overactive wakefulness, as opposed to treatments that generally sedate the brain.
In 2023, Idorsia Pharmaceuticals, which markets one of the DORA drugs, filed a Citizen Petition urging the Drug Enforcement Administration (DEA) to de-schedule the DORA class of chronic insomnia medications based on a review of available data and real-world evidence. With addiction becoming an increasing problem in America, Idorsia is hopeful that the DEA will consider de-scheduling the DORA class as it is critical in preventing the overuse of other medications, which are frequently abused or misused, to treat insomnia. Learn more. | | | | | | | Follow us on Twitter | | | | Follow us | | | | |
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