Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in FDA Week, in “Bill Eases Limits on 'Customer Service' for Research-Only Medical Tests,” by Erin Durkin.
Following is an excerpt:
The issue of customer service and business communications between a manufacturer and a customer is still a gray and uncomfortable area, said Bradley Merrill Thompson, an attorney for Epstein Becker & Green. He said the bill would allow manufacturers to answer unsolicited requests for assistance from laboratories that may be using the product clinically, communication that currently might be at odds with FDA guidance in this area.
"Manufacturers are telling labs that if you're planning to use the product clinically, we can't provide customer service," said Thompson. "[The bill] would allow vendors to provide those supporting services." …
Thompson said the bill not only codifies in law that FDA can't regulate manufacturers in this way, but it also broaches the issue of business communications that could be seen as promoting clinical use. He added that the language of the bill may need to be refined so that it is limited to unsolicited requests from labs for assistance, so vendors will not promote clinical practice. …
Thompson also noted that research use only products often serve as the foundation for LDTs. While Thompson said he could not see this piece of legislation serving as a basis for broad reforms to FDA's draft LDT framework, he said he could see this "possibly chipping away at the LDT issue."
