The just-departed commissioner of the Food and Drug Administration has concerns about plans to speed up drug approvals and dramatically reduce regulations at the agency, as advocated recently by President Donald Trump.
Dr. Robert Califf, who stepped down last month, shared his thoughts about keeping Americans safe — and making sure drugs actually work — after about a year overseeing the federal agency. His takeaways:
- Faster drug approvals, being advocated by Trump and others, don’t necessarily mean less expensive drugs.
Although faster drug development could bring development costs down, Califf said, “There’s not a direct relationship between the cost of development and the price of drugs or devices.”
- A law passed in December should streamline drug approvals — in a positive way.
The 21st Century Cures Act, a bipartisan bill signed by President Barack Obama late last year, is a “very well-rounded piece of legislation that will speed up product development.”
“Using real world evidence in clinical trials is one that I’m particularly excited about as a way to get better answers at a lower cost and faster at the same time,” Califf said.
[Read “FDA Officials - Including Commish Nominee Califf - Colluded with Device Industry to Draft ‘Cures’ Legislation”; http://sco.lt/7feuEz]
- But Califf has concerns about maintaining drug safety standards and ensuring thorough clinical trials.
“Declaring a drug is safe after very little information is treacherous,” Califf said.
Califf recently wrote for JAMA on the FDA’s balancing act of protecting the public and encouraging innovation. And the FDA released a paper last month documenting examples of a promising drug, vaccine or device that each did well in a Phase 2 clinical trial but “bombed out” in Phase 3, Califf said. Drugs typically go through three “phases” of studies called clinical trials before gaining FDA approval. With each new phase, researchers test drugs or other products on more people and on more measures of safety and effectiveness.
“It’s 22 examples of why it’s a big mistake to think that you can judge the balance of risk and benefit from a small amount of data,” Califf said.
[Read “FDA’s ‘Breakthrough Hall of Shame’ Rebuffs Opponents of Phase III Drug Trials”; http://sco.lt/7b0IM5]
- Faster, better drugs can’t be approved if the FDA is understaffed, he argued.
“A hiring freeze at this time when we are just revving up with 21st Century Cures is unfortunate. I hope that the dust will settle soon and the FDA can get back to its hiring,” Califf said.
[Read “Trump Freezes FDA & Puts 21st Century Cures in Jeopardy”; http://sco.lt/5ksbSb]
- The FDA is using big data to track the safety of drugs already on the market — and it plans to do that a lot more.
The FDA has an established adverse event database but after pain reliever Vioxx was pulled from the market in 2004, the agency began working on a system called Sentinel.
The initiative uses claims data to look at drug safety. It has 180 million individual electronic records and tracks every dispensed prescription, hospitalization as well as serious outcomes, Califf said. In addition, Sentinel is now being opened up to industry and academia.
[Read “So Far, FDA’s Sentinel Drug Safety Monitoring Initiative Has Not Delivered as Hoped”; http://sco.lt/7P4T3Z]
“It’s used every day by the FDA,” Califf said, adding that the system is “getting better and better.”