(This story previously appeared in The Hill Extra)
Former biotech executive Joseph Gulfo has been offering the Trump administration advice on how it could reshape the Food and Drug Administration.
It seems the administration likes what he has to say.
Gulfo, who sparred with the FDA over the approval of a medical device product from 2010 to 2013, is now on the list of candidates the new administration is vetting to lead the FDA.
As recently as Tuesday, Gulfo penned an article critiquing the FDA’s drug approvals over the last year. He also has been vocal about what Trump should do to get the agency “back to the basics.”
His plan would require the FDA to roll back its definition of safety and effectiveness, which Gulfo says has expanded over the years. It would also require a leader who is not afraid to take the heat, Gulfo told The Hill Extra.
“Remove the fear, get back to the basics of the law, and I think we’ll have a lot more innovation, we’ll have streamlined approvals, and we will not compromise safety,” he said.
Hands on experience.
Gulfo, currently executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, worked in the drug and device industries for more than 25 years.
Most recently, Gulfo was president and CEO of MELA Sciences, Inc. Their flagship product, MelaFind, was a diagnostic device for early melanoma detection.
Gulfo was responsible for obtaining FDA approval of MelaFind and gained national attention for challenging an initial FDA denial of the device. The agency later admitted at a congressional hearing that it mishandled the review.
His experience led him to write “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances.”
Gulfo’s basic message is that the FDA needs to reassess its definition of safety and effectiveness.
“You never prove a drug is safe,” he said. “What you learn is how to administer a drug safely.”
Gulfo suggests that a drug be approved on the basis of how it affects biomarkers associated with disease, as well as the drug’s effect on clinical signs and symptoms, the effect on disease modification and the effect on long-term outcomes.
If there are no problematic signs in clinical trials, the drug should be allowed on the market, he said. If public exposure reveals other side effects, that can be added to the label or, if necessary, the drug can be withdrawn, he said.
“I am not saying be cavalier, at all,” Gulfo said. “Let’s understand what safety means. It’s learning how to label it for safe use, and that learning never really ends.”
Take the heat.
Gulfo said FDA’s concern for drug safety has ballooned into fear — fear of getting yelled at for not approving drugs fast enough or approving them too quickly.
“They get yelled at right or wrong,” he said. “What do you do when you’re in a no-win situation? You don’t even try. … You basically are reticent to do anything.”
Safety has turned into risk-benefit analyses and effectiveness into clinical utility and long-term outcomes, he said. That’s caused the clinical trial and review process to be longer and more expensive, he said.
It’s also led Congress to approve more laws that create accelerated pathways for specific types of drugs — those that treat life-threatening diseases, or rare diseases, or diseases with few other treatments.
President Trump has issued a hiring freeze on all non-military positions, which could affect agencies like the FDA, which has hundreds of vacancies.
Gulfo predicts that if the FDA stops regulating out of fear and cuts some of its overly burdensome processes, the agency can make do with what it has.
“I don’t see the need for continually increased funding, but then there’s an offset to that,” Gulfo said. “We have to stop increasing the demands.”
See more exclusive content on policy and regulatory news on our subscription-only service here.
This article originally appeared at www.thehill.com on January 25, 2017.