| | | |   | | | | | Exclusive: Antibody options will soon be depleted, again  (Ted S. Warren/AP) Biden health officials are bracing for the prospect that the country’s sole preventive Covid-19 treatment for immunocompromised people could be ineffective this winter — leaving few other options in sight. AstraZeneca’s Evusheld is the only monoclonal antibody authorized as a periodic injection to prevent infection, used by roughly 17,000 Americans with weakened immune systems. But it’s not effective against BA.4.6, the rapidly rising subvariant accounting for at least 13% of current cases. There’s another catch: The next potential alternate, Eli Lilly’s bebtelovimab — could be ready within two months, but it has already been shown ineffective against the other fast-spreading variant, BQ.1. That puts federal officials in a bind and immunocompromised people on unsteady ground heading into the expected winter surge. Top officials including HHS’ legal counsel Stephen Cha and the FDA’s chief medical officer Hilary Marston met with representatives for immunocompromised patients on Oct. 4 to discuss potential options. But Biden officials privately complained to STAT that they’re limited by a lack of funding to push drugmakers to produce new monoclonal antibodies. Read more. | PhRMA keeps contributing amid price reform storm The pharmaceutical industry lobby has so far fallen a bit short of its pledges to make Democrats pay for their unanimous vote to let Medicare negotiate drug prices, the first major political loss for the industry in years.
PhRMA’s political action committee put $2,000 towards the New Democrat Coalition Action Fund on Aug. 22, just weeks after every member voted for the sweeping Inflation Reduction Act and its drug pricing provisions, including the negotiation plan and price hike fines.
While the lobby typically contributes to incumbent candidates in both parties, this and other donations came after CEO Stephen Ubl promised to hold Democrats “accountable” if they voted for the drug pricing reforms. In the weeks ahead of the vote, PhRMA also dispatched thousands of dollars to Senate Majority Leader Chuck Schumer’s IMPACT PAC and moderate Democrats like New Jersey Rep. Josh Gottheimer.
Ultimately, PhRMA and individual drug making giants did channel much of their PAC contributions to Republicans — but kept their options open. Pfizer, for instance, contributed $1,000 apiece to Democrats’ Senate and House PACs and $1,500 each to their GOP counterparts.
PhRMA works with lawmakers from both parties, spokesperson Brian Newell said in a statement. “While we may not agree on every issue, we will continue to work with lawmakers to explore every possible opportunity to ensure patients can get the medicines they need and our industry can continue developing lifesaving treatments.” More here. | Nearly 50% of women surveyed skipped cancer screenings according to Hologic’s Well Woman exam survey According to Hologic’s Well Woman exam survey conducted via Pollfish in January 2022, nearly 50% of the 1,000 U.S. women surveyed revealed they hadn’t seen a medical professional for a screening in the past year, risking later-stage diagnoses and worse outcomes. At Hologic, we’re tackling the biggest issues affecting women’s health, starting with routine screenings that drive better treatments and outcomes. Learn how we’re making health a priority at every stage of a woman’s life. | Justice Department sues Cigna over Medicare Advantage The DOJ on Monday filed a lawsuit alleging that Cigna overcharged the federal government by purposefully inflating how sick its Medicare Advantage members were, my colleague Bob Herman reports.
It’s a notable shift for federal prosecutors, who originally declined to intervene in the whistleblower case back in 2020 but who have gotten involved in similar cases over the past two years, including lawsuits against the Medicare Advantage plans operated by Kaiser Permanente and Elevance and settlements with others.
The Cigna lawsuit homes in on in-home assessments from practitioners, alleging the visits “were designed to generate revenue for Cigna, not to provide medical care or treatment” and some diagnoses weren’t followed up with care.
If that sounds bad, it is. One Cigna executive said home visits were about finding “the golden nuggets we are looking for,” according to the lawsuit. Those “golden nuggets … included conditions such as diabetes with complications, major depression, and vascular disease,” DOJ said. More from Bob, here. | Biden directs HHS to lower drug costs…again  (JIM WATSON/AFP via Getty Images) The president this weekend told federal regulators to come up with models to lower drug prices in Medicare and Medicaid, timely news considering those programs are already working on it. Medicare, of course, has just embarked on a plan to let the agency negotiate drug prices starting with 10 costly medicines. This month, the first wave of fines linked to price hikes past inflation also went into effect. And this summer, CMMI announced a revamped cancer care payment model. But Biden’s executive order and weekend campaigning come weeks before a contentious midterm election that could see Republicans take control of the House, if not the Senate too, where some GOP senators have already introduced legislation to roll back the Medicare price negotiation reform. “For years, there’s been no check on how fast Big Pharma — the big pharmaceutical companies — can raise drug prices,” Biden said at an Irvine, California campaign stop with Democratic Rep. Katie Porter. “But this year, the American people won. We took on Big Pharma and we beat them, finally.” Biden repeated the remarks in a Portland, Oregon, campaign stop the next day. Porter — who flipped a longtime GOP district in 2018 — has been an outspoken critic of prescription drug pricing since entering Congress. Her approach seems to be working: Porter’s district leans towards a Democratic majority in the midterms, according to the Cook Political Report. | What we’re reading - A House report alleges Trump aides blocked public health officials from providing accurate Covid-19 information during pandemic, CNN
- CDC: Signs point to an early start for flu season, with cases already ticking up in parts of the U.S., STAT
- The battle over pregnancy drug highlights risks of FDA expediting drugs to market, Politico
- What to know about Roche’s experimental Alzheimer’s treatment, STAT
| | | Thanks for reading! More Thursday,  | |
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