FDA Commissioner believes it’s time that some rules be placed around the lab-developed-testing industry.
At the annual conference hosted by AdvaMed, the largest devices and diagnostics lobby on Tuesday in San Jose, Scott Gottlieb declared his intent to have Congress legislate how LDT’s operate.
“I will tell you where I am right now is that I believe having been around this issue and having tried to grapple with it …we are at a point where we need some kind of legislation,” Gottlieb told the audience. “I think there’s a better consensus among the various camps around this issue that we could potentially get legislative consensus and I think that the time is right to do that. I will fully admit that I am working very hard toward that goal.”
He added that he has been and will continue to talk to folks on Capitol Hill.
“My view is that it would be a missed opportunity not to do it,” he said.
Going the legislative route means that the FDA is moving away from its previously envisioned regulatory approach without any input from Congress that the agency articulated in 2014.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Still, Gottlieb explained the need to have some rules governing this industry.
“The industry sort of — and I don’t want to be cynical — but there was a little bit of, “Let’s try to get a few more years in the framework we have’ and that worked for a while but I think that the level of complexity and risk in some of these tests and the public health issues that are there, the issues around reimbursement are acute.”
He added that the LDT industry’s character has also changed.
“This is now a mature industry. This is not an industry where FDA can continue to just exercise enforcement discretion because it’s a mom-and-pop industry and it’s a bunch of small operators. This is a vast industry and we are not going to be able to step away from it in the long run. I think the right way to approach is through legislation”
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