FDA's Bitter Pill

On June 23, a letter endorsed by APA and eight other scientific and professional societies was sent to the Food and Drug Administration (FDA) requesting clarification about how FDA solicits/incorporates expertise on drug abuse issues within the framework of its advisory committee structure.

On June 23, a letter endorsed by APA and eight other scientific and professional societies was sent to the Food and Drug Administration (FDA) requesting clarification about how FDA solicits/incorporates expertise on drug abuse issues within the framework of its advisory committee structure.

The letter was a follow-on to an effort initiated in November of 2000 when the drug abuse research community learned that FDA had planned to disband its long-standing Drug Abuse Advisory Committee.

The issue may have renewed currency as FDA has commissioned the Institute of Medicine to conduct a review of the US Drug Safety System.

While the charge to the IOM focuses mostly on evaluating post-marketing surveillance to better detect adverse events, in presentations to the IOM, part of what FDA referred to as the future of drug safety suggested that they need help in both pre- and post- market phases. For example, FDA's Critical Path Initiative calls for it to "incorporate cutting-edge science into clinical drug development". Further, FDA sites as a specific area of change "more outside expert consultations" and to "continuing our work to improve scientific methods of adverse event detection".

Congress too is expressing interest in the issue, especially as it applies to the development of abuse-resistant drug formulations. The report (H.R. 109-102) accompanying the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill for 2006 states:

"Abuse of Prescription Drugs.--The Committee is interested in the potential benefit from FDA's development of procedures for the processing and review of applications for approval for abuse-resistant formulations of schedule II painkillers and other prescription drugs currently on the market.

"The Committee notes that FDA priority review can be granted in cases in which the drug product 'would be a significant improvement compared to marketed products ... in the treatment, diagnosis, or prevention of a disease' including 'elimination or substantial reduction of a treatment-limiting drug reaction.' The Committee requests FDA to report on whether a drug less prone to abuse would be considered under that provision, and if so, how many drugs were considered under the provision due to less potential for abuse, and granted priority status.

"Additionally, FDA should take all appropriate steps to ensure that health care providers and patients are given all relevant information concerning the abuse-resistant qualities of safer drugs. Providers and patients alike will benefit from the expedited review of safer drugs, as well as the provision of information that accurately differentiates abuse-resistant formulations."

Dedicated SPIN readers will recall that APA recently co-sponsored a conference on the topic of abuse-resistant formulations.

Hopefully, with this confluence of forces attending to drug safety issues, we'll be able to report a positive response from FDA in a near-future edition of SPIN…stay tuned!