“When you talk to a doctor or a lawyer, there's medical privileges, legal privileges. There's no current concept of that when you talk to an AI, but maybe there should be.” —Sam Altman, The Atlantic (2024) Take it from the CEO of OpenAI: Confidentiality and privacy protections are among the biggest unresolved issues for those […]
If the FDA’s targeting of TV ads and social media influencers makes one thing clear, it’s that the biopharma industry is under the microscope. Promotions once considered “safe” are now fair game for untitled letters, warning letters and cease-and-desists. Understanding this new environment matters, but it is not the real story. The real story is […]
To build trust and relevance, and achieve better outcomes, life science companies must embrace cocreation early, often, and intentionally. After being told she had metastatic breast cancer, Jackie* was devastated. Was this the end of the road then? What about her kids, her husband? There was little energy left in the tank but she saw […]
When Robert F. Kennedy Jr. was nominated, I wrote that FDA could slow direct-to-consumer (DTC) advertising simply by finding more ads violative. Reviews are subjective: an ad can be flagged for over-promising efficacy or for distracting visuals during fair-balance disclosures. It now appears OPDP reviewers have been told to be tougher—and the flood of letters […]