Bradley Merrill Thompson Quoted in “CDRH Looks for Input on Guidance-Development Practices”

The Gray Sheet

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "CDRH Looks for Input on Guidance-Development Practices."

Following is an excerpt:

In 2012, the Combination Products Coalition, which represents device and drug firms, submitted a citizen petition to FDA requesting wholesale reforms to the agency's "good guidance practices," including requests, among others, that:

Proposed guidance documents submitted by the public be tracked and ultimately responded to by FDA;

The agency embrace informal communication with the public before and during the guidance development process; and

FDA finalizes or withdraws draft guidance, "not leaving guidance in draft form interminably."

The agency had to substantively respond to the petition, writes attorney Bradley Merrill Thompson, who coordinates the coalition, in a June 2 letter to FDA.

"These issues have only grown in importance in the intervening years," Thompson writes.

In particular, he suggests, companies are concerned about the number of documents that appear stranded in draft form. Thompson's firm, Epstein Becker & Green, performed a study of the issue last fall, and found at that time more than 90 CDRH documents going back to 1991 that have yet to be finalized. …

After the June meeting, "we would request that FDA move as quickly as possible to respond to our citizens petition, and, indeed, we would like to receive a response by the end of July," Thompson notes in his letter.