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Turna Ray Profile picture
@TurnaRay
Mar 5, 2019 • 3 tweets • 2 min read • Read on X
FDA Commissioner, Personalized Medicine Proponent @ScottGottliebMD Resigns genomeweb.com/molecular-diag…
The agency under @SGottliebFDA had a productive 2018 in terms of #personalizedmedicine approvals, diagnostics guidelines, recognition of the 1st public variant database #ClinVar, and efforts to incorporate real-world evidence in reviews genomeweb.com/molecular-diag…
@SGottliebFDA's FDA even took on the contentious issue of regulation of lab-developed tests and provided input on a draft bill #VALIDAct that would bring all tests under one regulatory pathway, the centerpiece of which would be a precertification program genomeweb.com/molecular-diag…

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More from @TurnaRay

Turna Ray Profile picture
Oct 2, 2020
This @HHSGov memo posted by @politico gives the lab industry adminsitrative legal cover to deflect FDA premarket review. But once lab tests enter the market, the memo discusses a legal path @US_FDA can use to remove bad actors. politico.com/f/?id=00000174… @davidalim
Look, even in its statement in August, @HHSGov said @US_FDA will not require premarket review of lab tests. It didn't say anything about all other levers the agency can use to rein in bad actors...including post-market actions. hhs.gov/coronavirus/te…
The few times FDA has taken actions against LDTs it has been against lab tests already being marketed (so technically not a premarket action). 360dx.com/regulatory-new…
Read 6 tweets
Turna Ray Profile picture
Sep 1, 2020
@HHSGov recently added an #LDT FAQ to the statement on its website that @US_FDA cannot require premarket review of LDTs w/out notice-and-comment rulemaking. Here's the FAQ: hhs.gov/sites/default/…
In the FAQ, @HHSGov states that "although FDA has asserted the authority to [mandate premarket review of LDTs], this requirement has in fact almost never been enforced. It was only being enforced during public health emergencies." This, in fact, is false and misleading.
As I recently wrote in @GenomeWeb, FDA under multiple presidents — George W. Bush, Barack Obama, & Donald Trump — has maintained that it has legal authority to regulate all diagnostics: IVDs performed at many labs and LDTs developed & performed in 1 lab. genomeweb.com/molecular-diag…
Read 13 tweets
Turna Ray Profile picture
Mar 4, 2020
Wrong. @US_FDA has for more than 20 years asserted it has jurisdiction over lab-developed tests. Just last year, the FDA under the Trump Administration warned a lab doing genetic tests for drug response (Inova) and maintained it can regulate LDTs when there's a pub hlth concern
And read FDA's actual statement from Saturday. The agency explains that while it is allowing labs to validate and perform coronavirus testing before they submit for an EUA, the EUA standards aren't changing. Labs still have to submit for EUA and notify FDA. Thus FDA has authority Image
And the @US_FDA under Trump-appointed @ScottGottliebMD provided extensive input on the VALID Act, a draft bill that would give FDA explicit authority over all diagnostics, including LDTs. Rumor has it might be introduced soon! genomeweb.com/molecular-diag… Image
Read 4 tweets
Turna Ray Profile picture
Feb 14, 2020
How can @23andMe claim its tests are better b/c they are @US_FDA approved, when the FDA says some of these tests (i.e. limited BRCA test) must be confirmed by another test that most likely will not be FDA approved?
@US_FDA approval is a poor measure of @23andMe's test quality as long as regulations are inconsistent. And yes, a lot of people have speculated that the disagreement between the lab community and FDA over regulation would be resolved "any day" since...the 1990s.
While true that @23andMe is the only consumer genomics firm to go through FDA, I'll also point out that the latest PGx oversight issue is prodding some companies take their tests through reg review.
Read 5 tweets
Turna Ray Profile picture
Aug 21, 2019
@Color to Use $4.6M @NIH Grant to Build @AllofUsResearch Genetic Counseling Resource
genomeweb.com/research-fundi…
@Color @NIH @AllofUsResearch Color will develop edu materials, work with a translation service to deliver telegenetic counseling in more than 200 languages, in addition to having English- and Spanish-speaking counselors, provide support from pharmacists, and connect participants to local healthcare services
@AmyCurrySturm, president of @GeneticCouns, will lead a genetic counseling steering cmte formed by Color to advise on challenging cases and other implementation difficulties that may arise
Read 7 tweets
Turna Ray Profile picture
Aug 19, 2019
Highlights from my latest @GenomeWeb piece on @US_FDA's stepped up actions on PGx testing genomeweb.com/regulatory-new…
@US_FDA appears to be going down a list of PGx labs, sending them letters that reference an earlier warning letter to @INova and asking labs to interpret what that means for them from a regulatory standpoint, but provides no guidance as to what specific actions they must take.
Labs are scrambling to decipher regulatory expectations. Meantime, labs are reporting only PGx variants detected in pts & removing mention of Rx or Rx classes online and from lab reports. Some hiring medical liaisons/relying on decision support to help docs understand reports
Read 9 tweets

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