AERS Apparent

The FDA announced today that it will post, quarterly, a report of drugs that are being evaluated for potential safety problems.  The FDA will base this list on adverse events reported through the agency’s Adverse Event Reporting System (AERS). The first report will be posted today.

This reporting mechanism is a requirement of FDAAA.

Ultimately, based on these evaluations, the FDA can require next steps ranging from (1) nothing – if the adverse events are determined not to be drug-related, (2) a risk management plan (REMS), (3) a label change, up to and including (4) a Phase IV clinical trial. It's important to note that all of these options can now, per FDAAA, be mandated by the agency.

This news was presented by Paul Seligman, MD (Associate Director of Safety Policy and Communication, CDER) and Gerald Dal Pan, MD (Director, Office of Surveillance and Epidemiology).  Both commented on the need to keep these warnings in perspective and both spoke to the issue of unintended consequences and that the agency would strive to communicate the information in the manner designed to avoid misinterpretation by patients and overreaction by the media.

(If you disagree that the media overreacts, let's see what happens tomorrow.)

One way to help modulate the unintended consequences (aka, "general hysteria") these things tend to generate is to make sure drug companies have some advance warning of these postings so they can be prepared to communicate their perspectives to patients, physicians and payers.  Will the FDA be advising companies that a given product will be included in the report?  It wasn't discussed during the press briefing.

Inquiring minds want to know (1) if "yes," how far in advance will a company be notified and, (2) if "no," why not?

More as more develops.