FDA Office Of Drug Safety In Transition; Director Raczkowski Joins Cephalon

Former FDA Office of Drug Safety Director Victor Raczkowski, MD, is joining Cephalon as VP-regulatory affairs.

Raczkowski resigned from FDA effective Oct. 3 after serving as head of the Office of Drug Safety for one year. Raczkowski took over as office director Sept. 9, 2002 (¹ (Also see "FDA Office Of Drug Safety Director-Designate Is ODE III Deputy Raczkowski" - Pink Sheet, 5 Aug, 2002.), p. 9).

Raczkowski joins Cephalon as it prepares to launch Provigil (modafinil) for expanded indications beyond its current narcolepsy market.

The company's immediate priority is to complete labeling negotiations over the exact scope of the indications. An FDA advisory committee recommended approval for use of the drug in shift workers and patients suffering from sleep apnea; the panel, however, split 4-4 on whether to recommend a broader sleepiness indication (² (Also see "Provigil Likely To Add Two New Claims; Broad Sleepiness Indication May Wait" - Pink Sheet, 29 Sep, 2003.), p. 25).

FDA will also presumably keep a close eye on Cephalon's roll-out of the new indications. The agency has previously objected to promotional materials used by the company on the grounds that they go beyond the indication (³ (Also see "Provigil Revamped Marketing Campaign To Launch After FDA Cites Promotions" - Pink Sheet, 21 Jan, 2002.), p. 36).

Cephalon also markets the breakthrough cancer pain lozenge Actiq (fentanyl), which is distributed under a risk management program that limits prescriptions to patients with indication-specified diagnoses (⁴ (Also see "Anesta Actiq Detailing To 2,500 Specialists To Begin In March" - Pink Sheet, 9 Nov, 1998.), p. 6).

Cephalon has made progress on its approach to regulatory affairs since its first attempt with the 1997 NDA for the ALS agent Myotrophin (mecasermin).

The company waged an aggressive public relations campaign to attempt to persuade FDA to approve the drug. The agency agreed to make the drug available under a Treatment IND, but demanded another study for approval. The Treatment IND was discontinued in 1999 and Cephalon stopped development.

Cephalon's regulatory affairs are currently overseen by Senior VP-Clinical Research & Regulatory Affairs Paul Blake. Raczkowski succeeds VP-Regulatory Affairs Kenneth White, who recently left Cephalon. The former FDAer will report to Blake.

At FDA, Raczkowski played a prominent role in the development of the Center for Drug Evaluation & Research's risk management tools, both in a hands-on capacity overseeing the application to reintroduce GlaxoSmithKline's Lotronex (alosetron) and at a higher level as a member of FDA's risk management executive oversight committee.

Prior to heading up ODS, Raczkowski served as Office of Drug Evaluation III deputy director and Division of Gastrointestinal & Coagulation Drug Products acting director.

During his tenure at ODE III and the GI division, Raczkowski had a supervisory role in each of the milestones for Lotronex. The irritable bowel syndrome agent was approved in 1999, withdrawn after failed risk management negotiations in 2000, and re-approved in June 2002 (⁵ (Also see "GSK Lotronex Plan Follows Accutane Model; Relaunch “Months” Away" - Pink Sheet, 10 Jun, 2002.), p. 3).

Raczkowski is the second ODS director to leave FDA for the private sector in two years. Peter Honig, MD, left the post to become Merck VP-risk management in February 2002 (⁶ (Also see "Merck Builds Risk Management Into Drug Development; Hires FDA’s Honi" - Pink Sheet, 21 Jan, 2002.), p. 21).

Office of Pharmacoepidemiology & Statistical Sciences Director Paul Seligman, MD, will serve as Office of Drug Safety acting director following Raczkowski's departure.

Seligman's term as Office of Drug Safety acting director will be his second; the OPSS director also stepped in as drug safety head when Honig resigned. ODS Deputy Director Anne Trontell will maintain her current position.

The vacancy in the directorship of the Office of Drug Safety comes as other positions within the office are being permanently filled. FDA is expected to announce permanent directors for the Division of Drug Risk Evaluation and the Division of Drug Surveillance, Research & Communication "very soon."

The divisions are both being led by their deputy directors on an acting basis. Mark Avigan, MD, is heading up the Division of Drug Risk Evaluation while Toni Piazza-Hepp helms the Division of Drug Surveillance, Research & Communication. The office's third division, Medication Errors and Technical Support, also has an acting director, Jerry Phillips. Carol Holquist is the deputy director.