Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, the Washington, DC, office, was quoted in an article titled “Coalition Uses FDA Device Guidance Meeting to Raise Bigger Process Issues.”
Following is an excerpt:
The Combination Products Coalition, in advance of an FDA meeting Thursday (June 5) on device guidance development, pressed the agency to respond to a 2012 citizen petition seeking changes to the guidance development process. The coalition is upset that many guidance documents remain in draft form for years instead of being finalized or withdrawn. …
Bradley Merrill Thompson, counsel for the Combination Products Coalition, said stakeholders hoped to use the meeting to raise problems with the guidance development process. He didn’t anticipate much of a response from FDA, though, as the agency prepares to respond to the Senate inquiry.
The coalition petition seeks improvements to the guidance development process such as finalizing or withdrawing documents rather than leaving them in draft form; using metrics to track agency progress; investing more time in planning guidance development; and embracing informal communication with the public during the development process.
Further, Good Guidance Practices — developed about 15 years ago — warrant a revamp, he said. Thompson said he hoped the meeting signaled an update to the guidance.
“While FDA’s GGPs addressed many of the challenges that were then facing the Agency and the industry at the time, we think now is the right time to reexamine the GGPs and refocus the Agency’s priorities,” according to the coalition letter. “New issues have arisen that require new approaches. It’s time for GGP 2.0.”