Why does it take more than 10 years for a new drug to be launched on the market? - FDA member, mart Makary - shared on social network X on May 7. Why dont we modernize with AI and things? We have just completed the first scientific assessment supported by AI for an AI product and that is just the beginning.
These statements were made after the annual meeting of the American Hospital Association earlier this week, where Makary talked about the potential of AI in supporting the approval of new treatments for diabetes and certain cancers.
According to wired, OpenAI met with FDA and two colleagues from Elon Musk's Department of Government Efficiency (DOGE) to discuss a project called cderGPT, an AI tool for the Center for Drug Evaluation (CDE). CDE manages over-the-counter and prescription drugs in the United States.
The FDA's drug evaluation process currently takes about a year, but the agency has some current mechanisms to speed up that time frame for promising drugs. One of them is the regulation on rapid monitoring, for products designed to treat serious conditions and meet unmet medical needs.
Another way is to prescribe a breakthrough therapy, created in 2012, allowing the FDA to grant priority assessments to drug candidates that could provide significant benefits to patients compared to current treatment options.
In January 2025, OpenAI announced ChatGPT GovPT, a self-storage version of the chatbot designed to comply with government regulations. The startup also said it is working to secure medium- and high-level FedRAMP certifications for ChatGPT Enterprise, allowing it to process government sensitive data.
FedRAMP is a compliance program used by the federal government to evaluate cloud products; unless authorized through the program, a service cannot store federal data.
