Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the Washington, DC office, was quoted in an article on the FDA’s new transparency initiative.
The article, “FDA transparency Team Fields 900 Comments And Counting For Final Report,” stated that the agency is currently reviewing heavy feedback about its new transparency initiative. Thompson, an industry representative of the Combination Products Coalition, is among those who say that the FDA’s guidance development process is most in need of an overhaul and the FDA should reexamine current Good Guidance Practices.
“Guidance is the agency’s primary vehicle for communicating regulatory processes and substantive expectations to the public and industry,” said Thompson in his comments to the FDA. “Good guidance creates transparency.”
Good Guidance Practices have brought “significant and laudable improvements,” Thompson acknowledged, but it is time the FDA refocused on certain fundamental GGP principles, such as allowing more informal communication during guidance development.
Meanwhile, the production of key guidance documents has slowed “dramatically” over the years, according to Thompson, and those that are issued are not always useful.