midterms
Democrats court MAHA voters
President Trump found his populist health care agenda in a MAHA movement that commandeered some of its elements from Democrats.
Democrats want those voters back, Daniel Payne reports.
With midterms looming, leaders across the party have been meeting with MAHA activists, discussing potential openings with consultants, and rolling out food and environmental agendas meant to entice these voters.
Read more about efforts to cleave anti-vaccine policies away from MAHA, while regaining the movement’s principles of government oversight in the food and medical system to rein in corporate power.
biotech
Sailing the sea of tariffs
The Biotechnology Innovation Organization is trying to help its members navigate a broad tariff on imported pharmaceuticals that took effect at the end of September, Chelsea Cirruzzo reports.
In April, the Trump administration announced a 100% section 232 tariff on patented drugs and their active ingredients. The White House offered ways for companies to reduce their tariff burden, including striking most-favored nation deals or agreeing to onshore production.
But mostly only large companies did that, and small and mid-sized biotechs are stuck trying to figure out how to appeal or request exemptions without clear direction.
Read more.
fraud
DOJ’s renewed focus on pharma
The Department of Justice last week issued a fraud-fighting directive that singles out the pharmaceutical industry, according to Ed Silverman.
The directive expressly includes the Federal Food, Drug, and Cosmetic Act. That’s a subtle but significant expansion of the National Fraud Enforcement Division’s jurisdiction, a former official in that division tells Ed.
Read more.
r&d
Bipartisan FDA policies for a divided government
A bipartisan duo of researchers published 12 FDA policies aimed at maintaining U.S. leadership in medical research and development, especially for individualized therapies, that they say could gain the support of both parties during a period of divided government.
The Stanford paper was written by Rohini Kosoglu, who advised the Biden administration, and Ryan Long, a senior research fellow at the conservative think tank Paragon Health Institute.
The recommendations span five thematic areas: trial initiation and early-phase development, methodological flexibility and evidence generation, individualized therapies and cross-program learning, review process predictability and international coordination, and development incentive sustainability.
The paper does not get into the politics of enacting the policies, but next year’s reauthorization of FDA user fee programs could be a vehicle for reforms. With significant turnover possible on the House Energy and Commerce committee, and as leadership of the Senate’s health committee is up in the air, the paper could serve as a guide for lawmakers who are new to drug development policies.
