The FDA (Food and Drug Administration) has released a guide for social media involvement with everyone from patients to pharmaceutical companies and healthcare providers. With deliberation for the past 2 years, the FDA provides guidance in how information can be given or obtained through social media. The public has been given 90 days to respond.
Here is a copy of their salient features, taken from their report.
This draft is intended to describe the Food and Drug Administration’s (FDA or Agency) current thinking about how manufacturers and distributors (firms) of prescription human and animal drug products (drugs) and medical devices (devices) can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off-label information) related to their FDA-approved or cleared products.
This does not address requests for information about approved or cleared 27 indications or conditions of use (on-label information) for FDA-regulated medical products. It also does not address requests for information about medical products that are not currently approved or cleared for any purpose. FDA’s guidance documents, do not establish legally enforceable rights or responsibilities. Instead, guidances describe the Agency’s current thinking.
The rapid growth of the Internet, including social media tools and other emerging technologies, has made it easier for both consumers and health care professionals to quickly seek information about medical conditions and treatments. Many firms have also used emerging electronic media to disseminate product information. As a result, firms may encounter requests for off-label information about their products through product websites, discussion boards, chat rooms, or other public electronic forums that they maintain and over which they have full control. In addition, third-party sites (i.e., websites and other venues that are either entirely independent of a firm’s control and influence or not fully controlled by a firm) also may reveal questions about off-label uses of a firm’s products. These questions about off-label uses are typically directed to users of the site at large, rather than directly and privately to firms. Such posted information is likely to be available to a much broader audience than just the original requester, especially because communication threads (i.e., questions and replies) are often available for an indefinite period of time.
FDA recognizes firms are capable of responding to requests about their own named products in a truthful, non- misleading, and accurate manner. As these firms are regulated by FDA and have current information about their products, FDA recognizes that it can be in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses of the firm’s products that are addressed to a public forum, as other participants in the forum who offer responses may not provide or have access to the most accurate and up-to-date 90 information about the firm’s products.
If a firm responds to unsolicited requests for off-label information in the manner described in this draft guidance, FDA does not intend to use such responses as evidence of the firm’s intent that the product be used for an unapproved or uncleared use. Such responses would also not be expected to comply with the disclosure requirements related to promotional labeling and advertising. Firms may choose to respond to unsolicited requests for information about off-label uses of their approved or cleared products in a manner other than that recommended in this draft guidance. Such activity would not constitute a per se violation of the law, but could potentially be introduced 99 as evidence of a new intended buy ventolin online canada use.
Unsolicited Requests
Unsolicited requests are those initiated by persons or entities that are completely independent of the relevant firm. (This may include many health care professionals, health care organizations, 111 members of the academic community, and formulary committees, as well as consumers such as patients and caregivers). A non-public unsolicited request is an unsolicited request that is directed privately to a firm using a one-on-one communication approach. The request could be directed to a firm specifically or posed to users of a discussion forum at large.
Solicited Requests
FDA considers requests for off-label information that are prompted in any way by a manufacturer or its representatives to be solicited. Such solicited requests may be considered evidence of a firm’s intent that a drug or medical device be used for a use other than that specifically approved or cleared by FDA. Although not exhaustive, the following examples illustrate what FDA generally considers to be solicited requests for off-label informationFDA has long taken the position that firms can respond to unsolicited requests for information 202 about FDA-regulated medical products by providing truthful, balanced, non-misleading, and non- 203 promotional scientific or medical information that is responsive to the specific request, even if 204 responding to the request requires a firm to provide information on unapproved or uncleared 205 indications or conditions of use. If responses to unsolicited requests fall within these parameters, 206 FDA has not expected those responses to meet regulatory requirements for promotional labeling or 207 advertising and has not considered these buy ventolin evohaler 100 mcg responses as evidence of intended use. This draft 208 guidance sets forth FDA’s current thinking on this topic, consistent with the Agency’s past policy 209 statements about responding to unsolicited requests.
FDA makes the following recommendations to a firm that is responding to a non-public unsolicited request for off-label information about its product that was specifically directed to the firm privately through a one-on-one communication. If an unsolicited question is broad in nature, the firm should appropriately narrow the question. In other words, the level of specificity of the question posed is important to ensure that the firm’s response is tailored to the request.
Information distributed in response to an unsolicited request should be truthful, non-misleading, accurate, and balanced. A response should provide non-biased information or data relating to the particular off-label use 264 that is the subject of the request, including applicable data that are not supportive or that cast doubt 265 on the safety or efficacy of that use.
The response can include unpublished data on file if 271 they are responsive to the specific request (either supporting or casting doubt on the safety or efficacy of the off-label use). However, to the greatest extent possible, a firm should rely on published peer-reviewed journal articles, medical texts, or data derived from independent sources. To the extent the response consists of published reprints from journals, those reprints should be 275 from journals that have a publicly stated policy, to which the organization adheres, of full disclosure of any conflict of interest or biases for all authors, contributors, or editors associated with the journal or organization. When responding to an unsolicited request for information, a firm should respond with material that is scientific in tone and presentation.
FDA recommends that questions or requests about off-label uses be referred to the firm’s medical 290 or scientific representative or department. FDA recommends that medical or scientific personnel have specialized backgrounds in responding to unsolicited requests for information.
Because sales and marketing personnel are focused by training and experience on promoting a firm’s products, FDA recommends that sales and marketing personnel have no input 298 on the content of responses to unsolicited questions or requests for off-label information.
Information distributed in response to an unsolicited request should be accompanied by the following:
- A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer
- FDA-approved patient labeling or, for new animal drugs
- FDA-approved client information sheet
The Internet has revolutionized communication, information-sharing, information exchange among 339 systems, and collaboration, enabling consumers to become more proactive about their health and safety. Consequently, the Internet has become a widely used medium for manufacturers and distributors of FDA-regulated medical products to disseminate information. The Internet has also spawned a variety of social media tools that host online content primarily created and published by users other than the intellectual property owner or product manufacturer. In some cases, this online content may not be accurate.
Because consumers increasingly use the Internet to search for information about medical conditions and treatments, firms may receive public requests for off- label information about their products through, for example, product websites, discussion boards, chat rooms, or other public electronic forums that they maintain and over which they have full control. Firms may also encounter requests for off-label information on third-party sites (i.e.,websites and other venues that are either entirely independent of a firm’s control and influence or not fully controlled by a firm). Questions about off-label use may be directed to the website users at large, rather than specifically to a firm.
However, because product information posted on websites and other public electronic forums is 361 likely to be available to a broad audience and for an indefinite period of time, FDA is concerned that firms may post detailed public online responses to questions about off-label uses of their products in such a way that they are communicating unapproved or uncleared use information about FDA-regulated medical products to individuals who have not requested such information. In this circumstance, communications to persons who have not requested information may promote a product for a use or condition for which FDA has not approved or cleared. FDA is also concerned about the enduring nature of detailed public online responses to off-label questions because specific drug or device information may become outdated (e.g., new risk information may become available).
FDA makes the following recommendations to a firm that chooses to respond to public unsolicited requests for off-label information about its product(s), including those encountered through emerging electronic media.
If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor’s product).
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Having guidelines such as the ones reported on above illustrate how the FDA will play an active role in safe-guarding the public in its quest to obtain healthcare information.
The public has until March 26th to submit comments or questions regarding the draft.