Boundaries of Expanded Access - Pharmaceutical Executive


Boundaries of Expanded Access
Patients are demanding drugs—and showing up everywhere from YouTube to the Supreme Court. But to offer access to investigational drugs, companies first need to know the rules

Pharmaceutical Executive

Know the Regulations

Expanded access programs provide significant benefit to critically ill patients. These programs can also benefit manufacturers by creating early visibility for a new product, and initiating physician and pharmacist engagement with a drug before it launches.

The possibility of a head start in gaining market acceptance for a therapy prior to launch can be particularly attractive for companies. However, whether governed by FDA or another regulatory body, the pharmaceutical industry must remain within the boundaries of the regulations governing pre-launch activity, and cannot actively promote these compassionate use programs.

What does that mean? As an overarching principle, companies can only respond to physicians' unsolicited requests for more information—which are often asked at medical conferences and in response to news of a company's late-stage trial. A few companies have also decided to post press releases announcing availability of their products via these programs—although others have shied away from that activity.

Solicitation of interest from target physicians, advocacy groups, or patients, however, is not allowed. Companies can't run advertisements, for example, or have their sales force promote expanded access programs. Crossing this promotional line could result in stiff penalties and negative publicity.

In the end, the growing power of patients means the demand for expanded access programs will only increase. To make the most of the humanitarian and market development benefits, companies must be familiar with expanded access options, the nuances of each, and where those boundaries begin and end.

Simon Estcourt is the global market access director of IDIS. He can be reached at

Benefit from industry updates and case studies related to this article at the 5th Annual Congress on Access Programs for Investigational and Pre-Launch Drugs, July 19-20, 2012, Philadelphia, PA


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