FDA Provides Guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices
Last month, the U.S. Food and Drug Administration (FDA) issued a draft guidance on the issue of responding to unsolicited requests for information about off-label use of prescription drugs and medical devices. (For the full text of the draft guidance, click here.) As we previously reported here, manufacturers and distributors of medical drugs and devices have pushed the FDA to release more concrete guidance on communications pertaining to off-label use, especially in light of the rapid growth of the internet and other social media tools and technologies. Off-label use occurs when a healthcare professional prescribes a product for a use or treatment indication not included in the products approved labeling. This draft guidance is aimed to specifically address solicitations for information received by product manufacturers regarding off-label indications or conditions of use.
The draft guidance clarifies the difference between unsolicited and solicited requests, and also differentiates between requests that are public and non-public. Solicited requests are requests for information that are “prompted in any way by a manufacturer or its representatives.” According to the draft guidance, the FDA may consider a solicited request as evidence of a firms intent to support or market a drug or medical device for a condition or use that has not been approved by the FDA.
Unsolicited requests, on the other hand, are “initiated by persons or entities that are completely independent of the relevant firm.” A public unsolicited request is made in a public forum. A question about off-label use of a specific product during a live presentation is one example of a public unsolicited request. A non-public unsolicited request is directed privately to a firm using a one-on-one communication approach. An example of a non-public unsolicited request is a call or e-mail for off-label use to medical information staff at a firm.
The FDA remains committed to its long-standing position that “firms can respond to unsolicited requests for information about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non-promotional scientific or medical information that is responsive to the specific request, even if responding to the request requires a firm to provide information on unapproved or uncleared indications or conditions of use.” For any response made to a non-public unsolicited request for off-label information, the FDA recommends that a firm provide information only to the individual making the request. In addition, the information contained in the response should conform to the following:
– Information should be tailored to answer only the specific question(s) asked;
– Information should be truthful, non-misleading, accurate, and balanced;
– Information should be scientific in nature; and
– Information should be generated by medical or scientific personnel, independent from sales or marketing departments.
In addition, the distributed information should be accompanied with a copy of the FDA-required labeling, a statement disclosing the indications for which the FDA approved or cleared the product, and a statement notifying the recipient that the FDA has not approved or cleared the product as safe and effective for use. If a firms response conforms to the FDAs new draft guidance, the FDA would not use the response as evidence of the firms intent to unlawfully support or market the product for an unapproved or uncleared use.
The FDA also addressed responses to public unsolicited requests for off-label information made through electronic media. Although the FDA recognizes that addressing off-label use to the general public can result in potential benefits to the public health, the agency continues to have significant concerns about broad, public responses. First, the FDA is concerned that product information posted on websites or other public forums may provide information about off-label use to individuals who have not requested such information, and would thus promote a product for a use or condition not approved or cleared by the FDA. Secondly, the FDA is concerned that the information posted on websites or other public forums would be available for an indefinite amount of time, and could pose a serious risk to public safety if new scientific advances render the posted information outdated or obsolete. Based on these concerns, the FDA recommends that firms only respond to requests pertaining specifically to its own named product. Further, firms should omit any information pertaining to off-label usage, should provide the individual requesting information with the firms contact information, and should recommend that the individual contact a medical/scientific representative with the specific unsolicited request to obtain more information. Any public response should disclose a representatives relationship to the firm and should not be promotional in nature.
In addition to this draft guidance, the FDA also issued a notice in the Federal Register on December 28, 2011, announcing the comment-period for scientific exchange. (For the full text of this notice, please click here.) At present, FDA regulations do not restrict the promotion of the “exchange of scientific information” regarding an investigational drug or device. The FDA, however, has yet to define the scope of scientific exchange. This notice, a direct response to a Citizen Petition jointly filed by several major pharmaceutical manufacturers, seeks comments on all aspects of scientific exchange communications and activities related to off-label uses of marketed drugs, biologics, and devices and use of products that are not yet legally marketed.
Specifically, the FDA seeks comments on how “scientific exchange” should be defined, what types of activities fall under scientific exchange, how to determine the players involved in scientific exchange, how it should be distinguished from promotion, and how the FDA should treat scientific exchange for products that have not been approved or cleared by the FDA. These comments will help the FDA to evaluate its policies on off-label uses and possible pre-approval communications. The FDA will accept comments through March 27, 2012.
Fuerst Ittleman will continue to monitor any developments in the FDAs regulation of off-label uses for medical drugs and devices. For more information, please contact us at email@example.com.