The National Taskforce — Get The Facts Campaign: On-Label and Off-Label Usage of Prescription Medicines and Devices, and the Relationship to CME

 In 1989, the National Task Force on CME Provider/Industry Collaboration was formed with the active participation of leaders from the medical profession, industry and the government and organizations such as the American Medical Association. The Task Force consists of 45 senior professionals in CME and related fields with various backgrounds in medicine and healthcare. The mission of the Task Force is to provide a leadership forum to impact national policy related to the provision, support, accreditation, and regulation of continuing medical education (CME). Task Force goals include the following:

• To bring together individuals from a variety of CME perspectives;
• To propose mutually derived ethical solutions to issues in CME;
• To disseminate news and information regarding CME;
• To safeguard continuing provider/industry collaboration and support for CME;
• To review and recommend guidelines and regulations pertaining to the interface between CME providers and industry; and
• To provide educational activities that support our mission and goals.

Recently, the Task Force began the “Get the Facts! Campaign,” which is a national effort to disseminate factual information on issues that are important and relevant to the CME community. In their “Call to Action,” the Task Force addressed how recent publications have been concerned with conflict of interest and bias in CME. Although they acknowledge that there are “many opportunities for conflict, bias, misrepresentation of facts and misinformed perceptions,” the Task Force also recognized “the confusion regarding the intent and purpose of CME for years.”

As a result, the Task Force established a Public Affairs Committee to identify critical issues and to address them by means of Fact Sheets. The Task Force noted that the Fact Sheets are important because they clarify the incorrect assumptions and false perceptions about CME held by the “media, state and federal law and policy makers as well as regulators and other “collective/consensus opinions.” Consequently, there have been four fact sheets so far:

 Continuing Medical Education: Providing Valid and Independent Evidence for Clinical Decisions;

 Continuing Medical Education: Addressing Conflict of Interest (COI);

 Pharmaceutical, Biotechnology and Medical Device Company Support of Continuing Medical Education; and

 On-Label and Off-Label Usage of Prescription Medicines and Devices, and the Relationship to CME

Their most recent fact sheet, dealing with on-label and off-label use of drugs and devices, described how healthcare products must be proven “safe and effective” by the FDA before they are marketed. Once approved, FDA and the manufacturer agree on, among other things, what the drug or device can be used and prescribed for.

Off-label use of a prescription drug or device refers to the ability of licensed health care providers to prescribe or use the drug for indications, conditions, patients, dosages or routes of administration not yet evaluated and approved by the FDA. The two most common reasons for off-label usage of medicines and devices are:

1)    To manage those diseases or indications for which a prescription medicine or device is currently being tested, has been tested or will be tested to assess the efficacy for a particular condition, and to include scientific evidence to suggest that the off-label usage of the product (prescription medicine) offers a viable alternative or clinical advantage over currently available options; and

2)    To prescribe doses of prescription drugs outside the range approved by the FDA.

The Task Force noted that off-label use of medications is very common with up to 20% of all drugs being prescribed off-label, and among some classes of cardiac drugs, off-label use can be as high as 46%. Off-label uses of device are more variable, and companies often evaluate the unapproved uses after the product is available.

Accordingly, the Task Force acknowledged that off-label discussion of product use is permitted within Certified CME activities when there is sufficient evidence for the off-label use and it is accepted within the medical profession as having adequate justification for the proposed use. Discussion must be at the discretion of the CME presenter without influence by the manufacturer or activity supporter, and:

• Must be evidence-based;
• Strictly limited to the discretion of the accredited provider within the activity;
• Cannot be positioned to encourage or promote off-label use for commercial purposes; and
• Have sufficient evidence and a balance between a product’s safety and efficacy must be presented to permit providers to make informed decisions when considering off-label drug use.

Ultimately, patients are served best when the provision of CME is based on the best available evidence. As a result, allowing the presentation of an off-label indication within the context of a CME activity will “provide healthcare providers with the most current clinical evidence for all available treatment options and when other therapies are not available or have not benefited the patient.” Such an approach will surely benefit patients and physicians.