Monday, February 24, 2020

Monday, February 24, 2020

‘This is nuts’: FDA program set to help doctors navigate bureaucracy


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Health care experts are expressing doubts about the FDA’s new call center, Project Facilitate, which is designed to assist physicians treating cancer patients.

Linda Gorman, director of the Health Care Policy Center at the Independence Institute, said the program exposes issues in bureaucracy.

“It's a great idea, but the problem is that it shows just how much bureaucracy we've got weighing down the health-care system right because now they have to hire another bureaucrat to help people manage the bureaucracy,” Gorman said.

According to the FDA, oncology staff will help physicians treat cancer patients through the process by submitting an Expanded Access request for an individual patient, including follow-up of patient outcomes.

Expanded Access, according to the FDA, is a pathway for a patient with an immediately life-threatening or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials “when there are no comparable or satisfactory alternative therapy options available.”

“This is nuts. Not that the special person is nuts, but the point that somebody would defend the entire regulatory system that requires the appointment of a special person,” Gorman said. “This is nice and everything, but it's not getting to the fundamental problems.”

Gorman said the main concern is the overall over-regulation of the health-care system, of which drugs are one part.

“I think it's stunning that the people who run the drug approval system have said ‘whoops it's so bad right now that we need to appoint a special person to help physicians navigate it,’” Gorman said. “Physicians, they're the experts, but the regulatory structure is now so complex, they can't navigate it and so we need a special person to help physicians navigate it.”

Gorman said that there is no certain way to know if the process will work.

“They say ‘look we're helping doctors and patients, we're appointing this person that you can call,’” Gorman said. “Well, you and I have both called a million call centers. Some are helpful and some terrible. So how do I know what it is going to work?”

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US Food and Drug Administration

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