Nonprescription Office In Transition Works To Hire Division Heads

Filling the posts of division directors is the current primary focus for Office of Nonprescription Products Director Charles Ganley, MD.

"The main thing that we've been trying to accomplish is to hire people for various positions," Ganley said in an interview with "The Tan Sheet."

"We're in the process of creating position descriptions and getting them approved by personnel and then moving forward trying to recruit for those positions."

The Division of OTC Drug Products was elevated to office status effective in May as part of a reorganization of the Center for Drug Evaluation & Research (¹ (Also see "FDA Office Of Nonprescription Drugs To Assume Switch Management Duties" - Pink Sheet, 13 Jun, 2005.), p. 3).

Directors of ONP's Division of Nonprescription Clinical Evaluation and Division of Nonprescription Regulation Development are the first positions that need to be filled, Ganley noted.

Deputy positions would be filled simultaneously or shortly thereafter, Ganley hopes.

"Over the next six months we really have to focus on developing the divisions to be individual divisions, allow them to develop their own identities," he said.

The establishment of division directors will allow ONP to shift from the operational model that existed under the previous division structure, which was also headed by Ganley.

"I don't want to be viewed as the dominant personality here that's dictating," Ganley explained. "Once a division director is in place, I can say, 'these are some of the objectives that I think you have to focus on, and you need to figure out how you want to get to that point,' and allow them to make those decisions."

Ganley would like to see staff below the division's head level be allowed to develop into "more independent thinkers." Some personnel who previously reported directly to Ganley now would report to the division directors, he added.

ONP also needs to fill some primary review positions "plus some other project management positions," particularly in the monograph division, Ganley said. "We are down two primary reviewers already on the monograph side, and so if there is any shortage of review staff it's on that side."

Overall, there are currently 37 people in ONP, with a ceiling of 43, according to CDER.

Approximately 22 to 23 are primary review positions, which do not include project management staff. Not all are filled.

An HHS hiring freeze makes hiring personnel from outside HHS more difficult because the office is required to get exemptions if it hires outside the Department.

Another transition for ONP is the move toward taking the lead on Rx-to-OTC switches from the therapeutic divisions.

Completion of the agency's Manual of Policies & Procedures for Rx-to-OTC switch proposals is "the main thing that needs to be accomplished before there is a full switch of responsibilities," Ganley said.

The agency has been working to revise the MaPP for more than a year in order to simplify the regulatory path for switch applications (² (Also see "FDA Rx-To-OTC MaPP On Course For Release In 2005" - Pink Sheet, 26 Apr, 2004.), p. 3).

The document will "lay out the various responsibilities for the new office, the divisions and our interactions with the other divisions and offices, and who the sponsors would interact with," Ganley said.

The MaPP "has been rewritten and redrafted and is currently being looked at again by the Office of New Drugs," he noted.

There is no set timeline for completion, but the MaPP will be discussed at the office directors' level and revised further, then put through a public notice process.

In the meantime, ONP is handling project management responsibility for switch applications in certain therapeutic categories "based on which divisions would like us to just take that over because it's inevitable," the office director said.

"There were some divisions we were piloting with and we are more or less continuing that process with them."

For example, ONP has accepted responsibility for antiseptic drugs and pulmonary drugs such as decongestants and antihistamines, and for some pain relievers.

In other cases, the therapeutic divisions will remain the primary contact. For example, the Division of Metabolic & Endocrine Drug Products will have responsibility for GlaxoSmithKline's switch application for the weight-loss drug Xenical (orlistat).

"So it is in that transition phase, which may make it confusing," Ganley said, noting that sponsors with questions can contact ONP, who will direct the inquiry to the appropriate office.

The ³ ONP page of FDA's website provides sponsors of investigational new drug applications or NDAs with contact information for appropriate project managers based on therapeutic category.

Ganley declined to discuss specific switches currently under consideration, but acknowledges he has met with companies working on applications that are "looking outside of the box, which can be a good thing."

However, self selection issues and "correct use of products" continue to be the dominant hurdles facing switches, he noted. Ganley stressed the importance of developing the methods used for communicating appropriate selection and use.

On the monograph side, ONP has taken initial steps toward improving the cumbersome internal processes for clearance of documents. Early in 2005, Ganley expressed an interest in making document clearance more efficient (⁴ (Also see "FDA OTC Head Ganley Talks Third Class, Plan B And Drug Switches" - Pink Sheet, 1 Jan, 2005.), p. 8).

The office has now "created a structure where there will be a group of people who are responsible for overseeing the clearance and the development of these documents and make sure they get pushed through in a timely manner," he said.

"The main thing that will help push it through is getting the additional review staff that we need and getting a division director in place there."

For monograph-related questions, the office is directing firms with queries to Project Manager Walt Ellenberg, PhD. Ellenberg has "been in the project management division for several years. He's the contact we are trying to direct people through."

- Christopher Walker