By Vincent Joralemon Pharmaceutical advertisers want health data so that they can effectively tailor the $18 billion spent annually on drug pitches to those audiences most likely to buy these products. However, a recent privacy law out of Washington State may force substantial changes in the field—potentially exposing a huge number of companies to liability…
By Rupa Palanki On September 20, the Federal Trade Commission (FTC) filed a landmark lawsuit against the three largest prescription drug benefit managers (PBMs) — Caremark Rx, Express Scripts, and OptumRx — and their affiliated group purchasing organizations. The FTC alleges that these entities engaged in “anticompetitive and unfair rebating practices,” artificially increasing insulin drug…
The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts. The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments. Harvard graduate students may register to take the workshop for course…
By Daniela Cepeda Cuadrado There is a wealth of research demonstrating that corruption — the abuse of entrusted power for private gain — has contributed to weakening health systems and worsening public health globally. Corruption is associated with a higher infant mortality rate, the rise of antimicrobial resistance, and the diversion of key resources to…
By Adithi Iyer In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Iovance’s AMTAGVITM, the subject of the approval, is a personalized immunotherapy for advanced melanoma. To be treated, adult patients who are ineligible for surgery or have metastatic disease provide their…
By Vincent Joralemon As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. For example, experts estimate MDMA-assisted therapy for PTSD will cost upwards of $12,000 per patient. These high costs highlight the need for comprehensive…
FDA rescheduling may provide a compelling model for efforts to decriminalize and destigmatize other substances moving forward.
Lykos’ current application is based on MDMA-assisted therapy, and FDA will almost surely require that patients take the drug in a clinical setting.
The telemedicine extension is not just for psychedelics; easing these restrictions means relaxing them for other controlled substances as well.
Not all lobbying campaigns are problematic — the goal should be for regulators to leverage industry insights while maintaining independence in decision-making.
