FDA Creates Comment Docket, Issues Draft Guidance on Off-Label Uses

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By Bronwyn Mixter  

The Food and Drug Administration is seeking comments and information on communicating off-label uses of marketed products and the use of products that are not yet legally marketed for any use, according to a notice published Dec. 28 in the Federal Register (76 Fed. Reg. 81508).

Separately, FDA announced a draft guidance, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, and is seeking comments on that document as well.

In the Dec. 28 notice, the agency noted that in a July 2011 citizen petition, Allergan, Eli Lilly, Johnson & Johnson, Novartis, Novo Nordisk, Pfizer, and Sanofi asked FDA to clarify its regulations and policies on when manufacturers may legally disseminate information on unapproved uses for drugs and devices (5 MELR 455, 7/13/11). FDA said the seven companies' petition requested clarification on areas including manufacturers' responses to unsolicited requests, scientific exchange, interactions with formulary committees and payers, and dissemination of third-party clinical practice guidelines. The law firms Ropes & Gray and Sidley Austin LLP submitted the petition on behalf of the companies.

FDA said it is currently evaluating its policies on sponsor or investigator communications and activities related to off-label uses of marketed products and the use of products not yet legally marketed. The agency said it would like to obtain comments and information related to the scientific exchange of information to assist with its evaluation.

Under federal food and drug law, it is illegal for a company to market its product for indications FDA has not approved, but manufacturers are permitted to share truthful, nonmisleading scientific information about their products.

Specific Information Sought

The agency said it is particularly interested in responses to the following questions:

• How should FDA define scientific exchange?

• What types of activities fall under scientific exchange?

• What types of activities do not fall under scientific exchange?

• Are there particular types and quality of data that may indicate that an activity is, or is not, scientific exchange?

• In what types of forums does scientific exchange typically occur?

• What are the distinctions between scientific exchange and promotion?

• Who are the speakers involved in scientific exchange, and who is the audience for their communication?

• Should the identity of the participants be given particular significance in determining whether an activity is scientific exchange or an activity that promotes the drug or device?

• How do companies generally separate scientific roles and promotional roles within their corporate structures?

• How should the agency treat scientific exchange concerning off-label uses of already approved drugs and new uses of legally marketed devices?

• How should the agency treat scientific exchange concerning the use of products that are not yet legally marketed?

• Should investigational new drugs and investigational devices be treated the same with respect to scientific exchange?

Comments on the agency's docket, identified by Docket No. FDA-2011-N-0912, must be submitted to FDA by March 27.

Draft Guidance

On Dec. 27, FDA's Office of Prescription Drug Promotion announced the draft guidance on responding to off-label information requests. The docket number for comments on the guidance is FDA-2011-D-0868, according to a notice FDA published in the Federal Register Dec. 30 (76 Fed. Reg. 82303). Comments are due March 29, while comments on a related collection of information are due Feb. 28.

FDA said the draft guidance provides recommendations to firms wishing to respond to unsolicited requests for off-label information, including both requests made directly and privately to firms and requests made in public forums, including through emerging electronic media.

The agency said it recognizes that firms are capable of responding to requests about their own products in “a truthful, non-misleading, and accurate manner.” Additionally, FDA said that it is in the best interest of public health for a firm to respond to unsolicited requests for information about off-label uses 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 information about the firm's products.

The agency said that if a firm responds to unsolicited requests for off-label information in the manner described in the draft guidance, it will not use such responses as evidence of the firm's intent that the product be used for an unapproved or uncleared use. Such responses also would not be expected to comply with the disclosure requirements related to promotional labeling and advertising, FDA said.

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, the agency said. Such activity would not necessarily be a violation of the law, but could be introduced as evidence of a new intended use, FDA said.

Recent Legal Challenge

The docket creation comes as another company, Par Pharmaceutical Inc., is challenging FDA in court over what it may say about its FDA-regulated products. Par in October filed a complaint seeking an injunction to bar FDA from enforcing regulations that Par claims prevent it from speaking freely to certain doctors about FDA-approved uses of its appetite stimulating drug Megace ES.

Although drug manufacturers may freely discuss on-label uses of FDA-approved products with doctors, Par's complaint says the FDA's ban on off-label communication also chills Par from discussing Megace ES's on-label uses with doctors who might also prescribe the drug for unapproved uses (5 MELR 687, 11/2/11). Par asked the U.S. District Court for the District of Columbia to declare that FDA's so-called intended use regulations are contrary to both the First Amendment and food and drug law.

For More Information

The Dec. 28 Federal Register notice is available at http://www.gpo.gov/fdsys/pkg/FR-2011-12-28/html/2011-33188.htm.

The citizen petition is at http://op.bna.com/hl.nsf/r?Open=deln-8jkr2b.

The draft guidance is at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf.