met nine times from its inception through June 2006, and it has generally discussed Patient Information Sheets, Public Health Advisories distributed by CDER, and ways to strengthen CDER’s risk communication efforts.
A Drug Watch Web page was proposed as part of FDA’s drug safety initiative in February 2005 to improve communication with the public on drug safety issues by putting information out as quickly as possible in an easily accessible format. The goal of the proposed Drug Watch program is to help patients and health care professionals make informed decisions on the use of prescription drugs. Drug Watch will include emerging data and risk information in a consumer-friendly form (information sheets) for healthcare professionals and patients regarding drugs for which FDA is actively assessing incoming safety information (FDA, 2005b,d).
A draft guidance on Drug Watch released in May 2005 (FDA, 2005f) discussed how the inclusion of a drug on Drug Watch would not signify that the drug is dangerous or should not be used; it only means that FDA is investigating emerging safety signals. The information on each drug would vary but could include “factual information about newly observed, serious adverse events associated with the use of a drug that have been reported to FDA”; “information about significant emerging risks that FDA believes may be associated with a drug, but that might be avoided by appropriate patient selection, monitoring, or use of concomitant therapy”; and notice of an important risk minimization procedure that has been put into place by the sponsor to alert healthcare providers and patients that there has been a change in how a drug should be prescribed, dispensed, or used (FDA, 2005f). The DSB role in overseeing the Drug Watch program was described above.
In September 2004, CDER announced that it would be restructuring the Office of New Drugs (OND) and has implemented this in phases throughout 2005–2006 (FDA and CDER, 2005). Phase I of the reorganization involved the elimination of the Office of Drug Evaluation V (ODE V), which began in May 2005 and is now complete. Phase II began in July 2005 with the operation of the new Office of Oncology Drug Products. It also involved the split of the Division of Neuropharmacological Drug Products in ODE I into two new divisions: Neurology and Psychiatry. Phase III began in September 2005 with reassignment of staff in the Division of Therapeutic Biological Internal Medicine Products and the Division of Review Management Policy