The Center for Drug Evaluation & Research Office of Postmarketing Drug Risk Assessment will seek to increase its research base in its budget proposal for the fiscal year beginning Oct. 1.

For its second year of operation (OPDRA officially commenced October 1998), the office will try to add more external database resources from which it can cull epidemiological information and "sentinel" sites to quickly determine emerging drug-related risks.

Following suggestions from FDA's Task Force on Risk Management report to Commissioner Jane Henney, MD, OPDRA is considering forging a relationship with a network of hospitals and healthcare providers that could act as "sentinels" and provide early warning of drug-related adverse reactions.

OPDRA also has spoken with the United Network for Organ Sharing about a consulting arrangement. The UNOS database affords FDA an enriched sample of patients who have received or are awaiting liver or kidney transplants and may have had organ failure because of an adverse drug reaction. The use of OTC acetaminophen among consumers of alcohol has been shown to increase liver damage.

The office already has several external consultants that provide medical data on more general populations. A typical study might examine prescription trends before and after "Dear Doctor" notifications. Collaborators include Harvard Pilgrim Health Care, United Health Care, Vanderbilt University and the Tennessee Medicaid database, and Johns Hopkins University.

As of Aug. 28, Peter Honig, MD, is the OPDRA deputy director, replacing Ralph Lillie, who is now CDER's Office of Information Technology director.

Honig said he intends to make "active surveillance" a priority within OPDRA. Current epidemiological research will further that principle.

For instance, the office will develop a draft guidance on periodic safety update reports, which will provide a more detailed summary of adverse event reports (excluding 15-day priority reports) than is currently required in the annual update for marketed products.

The new safety updates will be based on the PSURs described in the International Conference on Harmonization E2B and E2C guidelines. They will request not only a compilation of adverse event reports but also information on the populations using the drug, typical duration of use, and an assessment of ongoing epidemiological and other clinical studies as well as non-clinical studies that illuminate a possible mechanism of action.

The information will allow a quicker determination of the extent to which an adverse event signal would represent an imminent hazard to typical product recipients.

The year-old office also will continue to develop relationships with the new drug review divisions within CDER, Honig indicated. OPDRA is involved in several aspects of new drug approvals, including evaluation of Phase IV safety trials. The office also is involved in the pre-approval evaluation of proposed tradenames as part of an effort to reduce Rx dispensing errors. These two OPDRA tasks may be funded by user fees in the future.

Honig previously directed the division of Drug Risk Evaluation I within OPDRA. He will remain in that capacity in an acting role until a replacement is found. Honig joined FDA in 1993 as a medical officer in the pulmonary drug division and has chaired CDER's Committee for Advanced Scientific Education.

The division also gains another manager in former Pulmonary & Allergy Drug Products Division medical officer Anne Trontell, MD, who will join DRE I in the newly created position of deputy director. Trontell is an epidemiologist who previously worked at the Centers for Disease Control & Prevention.

DRE II also will add a deputy director under director Evelyn Rodriguez, MD. That position has not yet been filled. Overall, OPDRA's workforce represents about 70 full-time equivalents and is moving toward its limit, near 80 FTEs, although the new fiscal year budget may contain funds for more employees.

OPDRA is headed by Acting Director Murray Lumpkin, MD, who has a variety of other roles within CDER. The list of candidates from the search for a permanent director, which included ads in the Journal of the American Medical Association and New England Journal of Medicine this summer, is being narrowed.

Another change within the center's drug monitoring activities is the departure of MedWatch Medical Director Stephen Goldman, MD. He will join Knoll Pharmaceuticals as drug safety director.

FDA Postmarketing Office To Expand Research; New Deputy Director Is Honig

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