Thursday, August 9, 2018

Brief Blog: FDA Provides Deep Technical Assistance on Lab Reform Bill

Update:  Attorney Jeff Gibbs of Hyman Phelps has posted an article at FDA Law Blog where he both discusses the FDA documents in more detail, and posts a link to them.   Blog here.  FDA two-pager here, FDA 59 page legislative document here.


Original August 9 Blog:

While FDA lab test reform has been kicking around Washington for several years, a new landmark has happened.

FDA has provided detailed technical advice on the Hill legislative draft, according to   Advamed applauds the FDA's effort. 

See the trade journal article here, email registration may be required.   The FDA's information could support another round of hearings on the Hill, one step in the advance of any piece of legislation.  See also Genomeweb coverage, August 8, here.

The top line message:
Washington, D.C. – AdvaMedDx applauds Capitol Hill's release of technical assistance (TA) developed by the Food and Drug Administration (FDA) to draft legislation authored by Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO) as a significant, positive step toward enacting legislation modernizing regulation of all diagnostics, including Laboratory Developed Tests (LDTs). 
My understanding is that FDA provided higher level (or shorter) info to Congress in May 2018, as reported by Genomeweb (here).   This would be a longer, deeper-dive form of FDA feedback now.

On August 8, Advamed urged Congress to keep the legislative ball moving forward on diagnostics reform, here.  While in late June, Genomeweb reported that a lot of other stakeholders did not want that ball to move at all, here.

Genomeweb adds:
On Aug. 3, the FDA provided Bucshon and DeGette more detailed recommendations for how they might address regulation of so-called in vitro clinical tests via legislation. The FDA's version includes provisions related to premarket approval, provisional approval, and a precertification program, and makes explicit its authority to revoke approval, request raw data, and take corrective action against test developers in order to protect the public health. 
The FDA's response to the Hill was 59 pages, 23,000 words of legislative-format text; whereas the 2017 draft bill circulated by the Hill for comment was 215 pages and 43,000 words.