FDA Off-Label Policy Should Allow Dissemination With Disclaimer – CHC

FDA's off-label drug information policy should allow unfettered dissemination provided the manufacturer discloses that the information has not been approved by FDA, the Coalition for Healthcare Communication said in comments submitted to the agency.

"The coalition would support an FDA policy requiring full, complete, and unambiguous disclosure by a manufacturer that the enduring materials it disseminates...contain discussion of off-label uses not approved by the FDA, and that the manufacturer produces and markets the subject product," the coalition said in its Nov. 8 comments.

The comments, prepared by the Washington D.C. law firm Bennett, Turner & Coleman, were submitted in support of the Washington Legal Foundation's May 23 citizen's petition on off-label dissemination. The Coalition for Healthcare Communication comprises nine communications industry associations.

WLF's petition asks FDA to issue a policy statement replacing its March 16, 2000 Federal Register notice, which described the Washington D.C. federal appellate court decision that vacated the district court's decision to enjoin FDA from banning the dissemination of off-label reprints (¹ (Also see "WLF Appeals Court Decision Leaves Free Speech Question Open" - Pink Sheet, 14 Feb, 2000.), p. 3). WLF asked that FDA issue a policy statement indicating "its willingness to abide by the district court's decision" (² , p. 13).

The communication coalition's comments request that FDA withdraw the March 2000 notice and replace it with a notice describing a "full disclosure" policy.

A policy that would allow off-label dissemination accompanied by full disclosure of the source of the information and its unapproved status "still achieves [FDA's] primary objective of preventing the communication of false or misleading information and...is not so overly broad as to restrict a manufacturer's right to engage in lawful, nonmisleading communications," the coalition said.

The comments maintain that a full disclosure policy would "protect the interest of all concerned parties."

"The policy immediately notifies the reader of the source of the information being conveyed, putting the reader on notice to receive the information with inherent skepticism based on his or her education, background and experience," the coalition said.

The policy would also maintain FDA's enforcement authority, the comments say.

"The FDA's enforcement powers are preserved if a manufacturer fails to disclose the nature of the information being communicated, since the FDA could then argue that the information is 'inherently misleading'....FDA can still move against a manufacturer if the information being conveyed is in fact false or misleading."

The coalition's comments object to FDA's statement that it could act against manufacturers that do not comply with the off-label dissemination restrictions in the FDA Modernization Act and its implementing regulations.

The comments cite a July 9 FDA letter to AstraZeneca regarding information disseminated at the American Society of Clinical Oncology's 2001 annual meeting.

Since publishing the notice, "FDA has already sent an untitled letter to a drug manufacturer for distributing copies of an abstract taken from a peer-reviewed medical journal that discussed the off-label use of an oncology drug," the coalition says.

In the letter, FDA objected to an abstract AstraZeneca distributed at ASCO describing an unapproved combination use of Arimidex (anastrozole) with Zoladex (goserelin). The agency said that a disclaimer attached to the abstract stating "For Medical Use Only - Not approved in the U.S." did not correct what it considered to be a violative promotion of an unapproved use (³, p. 11).

To illustrate how off-label uses can be important for public health purposes, the coalition pointed to the current bioterrorism scare.

"Even FDA has acknowledged that off-label uses can be of great value, with some having great historical importance, such as off-label uses of beta blockers in hypertension and angina," the coalition said. "Most recently government officials have commented on the availability of certain antibiotics for the off-label treatment of anthrax."