easy parking…

Posted on Friday 22 April 2016

Califf said the FDA has to work with industry so it doesn’t fall behind on changes in medical science.
By Sheila Kaplan
April 19, 2016

The new Food and Drug Administration chief says the agency has to work with industry groups so it can keep up with the latest developments in medical science — because otherwise, even the agency’s best experts will fall behind. In a wide-ranging talk Tuesday to the Alliance for a Stronger FDA, a group devoted to increasing the agency’s funding, FDA Commissioner Robert Califf revisited the big issue critics raised before his confirmation nearly two months ago: the need for the agency to stay independent of the industry group it regulates.

At the time, some Democratic critics worried that he was too close to the pharmaceutical industry, and Califf eventually convinced most of them that he would stay independent. On Tuesday, however, Califf insisted that in order to stay up to date on breakthroughs in science and technology, the FDA must work with those who are developing the innovations. “We have to be able to interface effectively with people that we regulate, which is extraordinarily touchy territory,” Califf said. “Getting this right is not something I can do; it needs to be a consensus of the community we work in.” “We have to keep our sanctity of regulation, but we have to be fluent with the outside industry, as the knowledge changes so rapidly,” he said.

Califf was confirmed by an overwhelming Senate majority on February 24, five months after President Obama nominated him. It was a long haul, in part because some opponents did not like research he conducted or oversaw at Duke, much of which was funded by pharmaceutical firms. But today, in front of 80 people from patient advocacy groups, corporations, and trade groups, Califf insisted that the FDA’s relationship with industry is a practical reality…

That the FDA has to work with industry and keep up with scientific advances goes without saying. I don’t think that’s the question on the table here. The issue is more "Does the FDA work for industry?" If you’re not acquainted with what I’m talking about, this would be a good time to take a look at the approval process for Zoloft in 1990 where the FDA head strong-armed a New Drug Approval [NDA]…

… or the Supplemental New Drug Approval [sNDA] for Rexulti as an adjunct in Treatment Resistant Depression last year where the FDA medical reviewer stretched the standards:

I’ve been impressed that the majority of the FDA New Drug Approval [NDA] Medical Reviews I’ve read [which is most of the psychiatric drugs from Prozac forward] were on the mark. Their standards [proof of safety and two positive studies] are by mandate and will do. My complaints are about the political interference in more than a few decisions [examples above], the lack of vigorous post-marketing review, vigilance in monitoring advertising, and something else big. It’s hard to talk about the advertising part because Direct-to-Consumer advertising should be banned in any form, so it gets complicated what the FDA should take on. But I would say that accuracy would best describe the FDA’s domain of vigilance.

Something else big? Data transparency. The FDA should release all Phase III submitted information on a New Drug Approval [NDA] the day the drug is approved. If the drug company wants to protect Commercially Confidential Information, don’t submit it to the FDA in the Phase III Clinical Trial package. How hard is that? Califf isn’t going to champion Data transparency, but he should. Absent that, what can we expect from him? Honesty, keeping his nose out of his reviewers’ business, and being a thoughtful Administrator. I think he might be good at the latter based on his work at Duke and this statement…
“We want a happier, more satisfied group of employees who can progress in their professions,” he said. For starters, he added“we’re working on the parking issue.”
Easy parking, offices with windows, and firing incompetents on the day of detection are the essential keys to good administration. For what it’s worth, I would expect to be bothered by his previous connectedness with industry, but while it worries me, he actually strikes me as a competent guy. We’ll see…
    April 25, 2016 | 11:01 AM

    People who use “interface” as a verb always make me nervous.

    James O'Brien, M.D.
    April 25, 2016 | 5:17 PM

    It’s the same group that uses “impactful” as an adjective.

    April 25, 2016 | 9:36 PM

    “Impact” as a verb that’s synonymous with “affect” is also problematic.

Sorry, the comment form is closed at this time.