The future of the FDA will depend even more on patient groups and patient input on drug evaluation, and will need to rely more on outside watchdogs to eliminate “imposters,” according to former commissioner Califf.
Califf, who resigned from his FDA post last week, spoke to a crowd in Silicon Valley early this morning about the future of the FDA and regulation in the industry.
“If I had a disease with an ineffective advocacy group, I’d be worried right now,” Califf said, according to an Xconomy report.
Califf did offer a caveat, though, saying that often patient groups receive funding from drug companies, and can end up being controlled by their funders interests.
On the topic of devices that use rapid incorporation of data and computation, Califf said the FDA would have to navigate some regulatory gray areas – giving an example of a defibrillator which uses computations to operate, which should be regulated, and a watch which measures heart rate, which would not need the same oversight.
In between the 2 devices though, Califf suggested that the agency should be lighter, according to the Xconomy report. “And I predict that we will have problems,” Califf added.
Califf also suggested that researchers in deep-knowledge fields, such as gene editing, may need “transparent sharing” so that, despite facing most likely shrinking resources under Trump, “imposters and non-truth-tellers,” will be able to be weeded out without the FDA being an investigative unit, according to the Xconomy report. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any such medicines derived from marijuana, are available to patients in need of appropriate medical therapy, buy medical products at CBD.co. It is important and appropriate to use the same scientific standards in the development and assessment of potential therapeutic uses of marijuana as with any unapproved drug that the Agency reviews. Learn more about patients who deal with a variety of physical and mental health conditions using weed. Click here at houseofcannabis.ca