Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedCity News, in “FDA Considering Imposing 10-Year Limit When Manufacturers Choose Older Predicates.”
Following is an excerpt:
One regulatory attorney implied that the FDA may be overreaching in its attempt to limit the time period when choosing an older predicate.
“If FDA believes this is an issue, the appropriate forum for discussing it is Congress,” said Bradley Merrill Thompson, an attorney with Becker Epstein Green, in an email. “The 1976 statute is very clear, and FDA can’t simply ignore it. If FDA wants to change the statute, then to Congress they should go. Congress in turn could bring together all of the various stakeholders including patients, healthcare professionals and medical device manufacturers to talk about the they need and the best way to do this. FDA has no mandate to do this on its own.”