The U.S. Food and Drug Administration (FDA) and OpenAI are collaborating to determine whether artificial intelligence (AI), could lead to drug approvals more quickly. At the moment, it takes more than 10 years to bring a new medicine from labs to pharmacies. The FDA hopes AI can cut this time so patients get life-saving drugs sooner.
The project, called cderGPT (likely short for Center for Drug Evaluation and Research GPT), is in early talks. No deal is signed yet, but FDA leaders have met with OpenAI teams and a group linked to Elon Musk called the Department of Government Efficiency (DOGE).
How AI Could Help the FDA
Fixing Slow Drug Reviews
The FDA checks if new drugs are safe and work well before approving them. This process usually takes about a year. AI could help in three ways
- Checking Paperwork: AI could quickly scan drug applications to make sure all forms are filled out correctly.
- Analyzing Data: AI could read through thousands of patient records or lab results to spot problems or benefits faster than humans.
- Writing Reports: AI could draft summaries of scientific studies, saving time for FDA scientists.
FDA leader Marty Makary said the agency did its first AI-assisted drug review recently. He wants to do more.
Why Some People Are Worried
The Problem With AI Mistakes
AI tools like ChatGPT sometimes make up fake information that sounds real. A former FDA worker who tested ChatGPT said this is risky for drug reviews. “What if the AI misses a dangerous side effect because it guessed wrong?” they asked.
Rafael Rosengarten, a healthcare AI expert, says rules are needed to train AI properly. “AI needs good data to learn from. If we feed it bad info, it will make bad choices,” he explained.
What the FDA Is Already Doing With AI
The FDA has quietly used AI for years. For example, it uses AI to track drug side effects after they hit the market. In late 2023, the FDA offered a job to someone who could build AI tools for drug testing and patient care.
OpenAI is also preparing for government work. It made a special version of ChatGPT called ChatGPT Gov that meets strict security rules. This lets it handle private health data safely.
What Drug Companies Think
Big pharma groups like PhRMA say AI could help, but warn it must be used carefully. “Patients’ safety comes first. We need to test AI tools slowly,” said PhRMA spokesperson Andrew Powaleny.
Former FDA leader Robert Califf agrees. He says AI could help with early drug research, not just final approvals. Most drugs fail in early testing, so fixing that stage would save more time.
Will AI Replace FDA Workers?
Experts say no. AI will assist humans, not replace them. For example, AI could flag a promising cancer drug for faster review, but scientists would still decide if it’s safe.
The FDA already has ways to speed up reviews for urgent drugs, like those for rare diseases. AI could make these “fast track” programs even quicker.
If the FDA and OpenAI succeed, patients could get new medicines years faster. But AI must be trained on good data and checked for errors. As one expert put it, “AI is a tool, not a miracle worker. We still need smart people to make the final call.”
