The Office of Nonprescription Products' goal of completing all OTC monographs by 2010 is viable only if FDA improves its document clearance process, according to ONP head Charles Ganley, MD.

"If we can't get the clearance process improved in that regard, I think it is probably unrealistic," Ganley said in an interview with "The Tan Sheet."

"If you can get things done in a more timely manner, then I don't think it is out of the question."

Ganley and ONP Associate Director Susan Johnson, PhD, set the goal at a Cosmetic, Toiletry & Fragrance Association conference in February ¹ Also see "ONP: Leaner, Meaner In 2006" - Pink Sheet, 6 February, 2006., p. 3).

The challenge of document clearance at the agency has been a perennial topic for Ganley, who has repeatedly cited clearance delays as a hindrance to regulation development.

"Those are things that are out of our control," he said. "It's a more global issue within FDA, of getting that process improved."

Ganley speculated that a permanent FDA commissioner could help address the clearance issue.

If Acting Commissioner and nominee for the permanent post Andrew von Eschenbach is confirmed, the agency could "potentially see some improvement there," Ganley said.

Internally, ONP still is looking to fill the director post for its Division of Nonprescription Regulation Development (DNRD); Johnson serves currently as acting head. Ganley also hopes to continue to separate that division's workload from the Division of Nonprescription Clinical Evaluation (DNCE).

"Hopefully by next year" the office will have a leader for regulation development, he said, "so that the workload is better defined for each division."

FDA plans to re-announce the DNRD director opening; a technical problem disrupted an earlier attempt at the process, Ganley said.

"There's still some overlap [between DNRD and DNCE] in terms of responsibilities that we have to separate a little further," Ganley said. "The one that's mainly involved in regulation writing is still doing a lot of the labeling reviews from new drug applications."

Until DNCE, which handles NDAs, has a staffer to handle labeling reviews, "that's going to impact the workload and the output from the regulation writing division," Ganley said.

In Clinical Evaluation, aside from the need for someone to conduct labeling reviews for NDAs, "we are pretty much caught up," Ganley said.

"They may need another medical officer there too," he allowed, but added DNCE has "a fairly good complement of people in there right now."

During 2006, ONP named Andrea Leonard-Segal, MD, director of DNCE. Joel Schiffenbauer, MD, formerly of the Office of New Drugs' Division of Anesthesia, Analgesia & Rheumatology Products, serves as deputy director.

ONP's full-time equivalents are up to 44 from 37 in 2005. The office's employee ceiling is 46.

In addition to filling the open division head post, Ganley's 2007 goals include making progress on rulemakings and actions in response to citizen petitions and time and extent applications.

"We need to start getting those regulations out of here," he said.

Stakeholders can expect more plain language in those regulatory documents, Ganley said.

The regulation development division has "our own internal editor now, so we are trying to transition the documents now to more of a plain language style, using the question and answer format. Hopefully those types of issues aren't obstacles in the future," he said.

"A lot of it is workload management for people who have to clear those documents," he explained. "There's a lot of work to do and people are just short-staffed on getting things done as fast as you would like."

Ganley hopes the agency can publish planned guidances for actual use and label comprehension studies in the next year.

Separate guidances for these consumer behavior trials were on CDER's agenda for development in 2006 (² Also see "Actual Use, Label Comprehension Guidances Slated For 2006" - Pink Sheet, 6 March, 2006., p. 5).

In September, the agency convened the Nonprescription Drugs Advisory Committee (NDAC) to discuss issues related to consumer behavior trials (³ Also see "NDAC Calls For Predefined Endpoints In Consumer Behavior Trials" - Pink Sheet, 2 October, 2006., p. 3).

"Hopefully we can move forward on those two documents given what we heard at the advisory committee meeting," Ganley said.

The guidances are likely to reflect key areas the NDAC panel focused on.

Ganley discussed what the agency saw as the primary take-away message from the September meeting. The panel generally agreed FDA and sponsors should set "thresholds as to what the studies should try to achieve, and pre-specify those thresholds," he noted.

In terms of measuring outcomes "they'd prefer to have us use the confidence interval approach as opposed to a point estimate approach, and use the lower confidence interval [as a boundary] where it shouldn't go below the threshold," he added.

"We talked about it initially, and how it will come out in the document may be different than that, but I think that's something we heard clearly from the committee," he said.

Ganley also outlined the developing division of labor as ONP continues to assert responsibility for NDAs. When ONP was elevated from division to office status in 2005, primary review responsibility was shifted to the office from the relevant therapeutic divisions (⁴ Also see "FDA Office Of Nonprescription Drugs To Assume Switch Management Duties" - Pink Sheet, 13 June, 2005., p.3).

ONP is still working on a planned revision of the Manual of Policies & Procedures for Rx-to-OTC switch products, which should clarify the internal switch review process, Ganley noted. There are still some divisions that handle primary regulatory responsibility, but ONP handles "most of the applications that come in," he said.

"We are probably going to take more ownership of doing the safety reviews than we have had in the past, and that may be the only difference. An efficacy study will still go to the collaborative division that we are working with," he said.

Consumer behavior studies will remain in ONP's purview.

"There are some applications where we may take full responsibility, such as the antiseptics and some of the sunscreen products. There may be minor things that may be done with other divisions, but I think those are things where we may take more responsibility," Ganley said.

- Christopher Walker

FDA Clearance May Thwart Monograph Goal; Ganley Talks Turkey About ONP

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