Industry wants FDA's dispute resolution process to allow for less structured interaction during the appeals process, Merck Manufacturing Quality Assurance Director David Haggard said.

"Oftentimes, even when the firm submits their position in writing, there may still be [further] clarification that the parties may want to" discuss, he said during a Drug Information Association conference in Bethesda, Md. March 3.

"It would be an important element to include that flexibility for the firm...to make sure that there is that feedback back and forth as to whether they correctly identified the issue."

Haggard also supported extending the 10-day deadline to challenge FDA inspection findings which was set in the draft guidance outlining the dispute resolution process for good manufacturing practices.

"I would caution that some of the issues that come up during inspections are quite complex, that they require the firm far more than 10 days to properly try to interpret what the investigator meant by the observation," Haggard said.

Other types of "dispute resolutions give people at least 30 days to prepare and I would suggest that it would be valuable," he said.

Clementi-King Managing Partner Kenneth King suggested that the initiation of the dispute resolution process should be more formal.

"My understanding is that most of the disputes can be resolved at the first level...and if that is indeed true, then one of the things that I would propose we might want to talk about is a more formal informal first step," he said.

King also suggested that an analysis following the dispute resolution process would be valuable to see if the outcome justified the resources used.

"The issue for me would be does the resources justify the payoff and I would suggest we might want to consider a post-process relationship check," he said.

A 12-month domestic pilot under the draft guidance began Jan. 1 (¹ [A#00660020022], p. 39).

The pilot, which only covers scientific and technical GMP issues, has received several requests for participation.

The agency is planning on anonymously sharing case results in order to prevent future disputes on the same issues from occurring.

"What we intend to do periodically is take the results of these disputes and anonymize them and put them in a Q&A format," Center for Drug Evaluation & Research Office of Compliance Director David Horowitz said.

"We intend to issue this guidance, this sort of informal Q&A guidance, in real-time, as quickly as we can to get it out," he said.

CDER expects to publish the final guidance January 2005. "We hope to have the comments in, learn from the pilot experience and have the guidance finalized early 2005, January if possible," Horowitz said.

The FDAer suggested that an additional subcommittee of the Pharmaceutical Sciences Advisory Committee could deal strictly with GMP issues.

"We could form another subcommittee...of the Pharmaceutical Sciences Advisory Committee to more directly field GMP issues," he said.

Office of Drug Evaluation IV Director Mark Goldberger, MD, identified key points that can facilitate better dispute resolution meetings.

"One of the worst things is for us to identify issues and then wait till industry comes into the meeting, bring up the issues at the meeting with industry not being prepared to address them adequately. I don't think that's very productive. So we tried as much as we can to identify additional issues" and tell industry beforehand so they can be prepared.

Office of New Drugs Director John Jenkins, MD, added that although there are places where it is appropriate, discussions will be more open if manufacturers leave their counsel out of the meetings.

FDA Dispute Resolution Process Should Be Less Structured, Merck Exec Says

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