Food and Drug Administration - June 5, 1998

When finalized, these rules will implement a provision of the Food and Drug Administration Modernization Act of 1997 (FDAMA) allowing manufacturers and sponsors to impart this information to health care practitioners, pharmacy benefit managers, health insurance issuers, group health plans, and Federal and State agencies. The proposed rules, which closely track the FDAMA provisions, specify the type of "off-label" or unapproved use information that can be disseminated, and under what conditions it must occur. Under FDAMA, FDA must study its experience with the provision, and the provision will sunset September 30, 2006 or seven years after the final regulation, whichever comes first.

William B. Schultz, FDA Deputy Commissioner for Policy, noted that in the past the concept of allowing manufacturers to disseminate "off-label" information raised concerns about diminishing a manufacturer's incentive actually to develop the safety and efficacy data about these uses that would lead to their approval -- concerns addressed by the legislation and implemented in the proposed rules. "FDAMA and the new proposed rules tie dissemination of this information to a commitment to do the necessary research on the new uses," Mr. Schultz said.

"These proposed rules are intended to implement the statutory provision which will allow health care practitioners to receive information about unapproved uses of approved medications and devices and to stimulate the development of new studies or collection of existing evidence about off-label uses for FDA's review."

Under the proposal, firms or sponsors no longer would have to wait until FDA approves their supplemental application before disseminating certain reliable information about unapproved uses of their products, provided the information: concerns a drug or device that has been approved, licensed, or cleared for marketing by FDA;

is in the form of an unabridged reprint or copy of a peer-reviewed scientific or medical journal article, or an unabridged reference publication, about a clinical investigation that is considered scientifically sound by qualified experts;

--does not pose a significant risk to the public health;

--is not false or misleading;

--is not derived without permission from clinical research conducted by another manufacturer; and

--includes certain disclosures (e.g., that the new use has not been approved by FDA), the official labeling, and a bibliography of other articles relating to the new use.

The manufacturer also would have to submit to FDA, 60 days prior to dissemination, a copy of the information to be disseminated and other data specified in the proposal.

A firm that has not submitted a supplemental application for the new use could begin disseminating information if it has:

--certified that it has completed the necessary studies and that a supplemental application will be submitted within six months;

--provided an adequate protocol and reasonable schedule for the necessary studies and certified that the application will be submitted within 36 months of the initial dissemination; or

--received an exemption from the requirement to submit an application on the grounds that the necessary studies would be unethical or economically prohibitive.

If FDA determines that the information is not objective and balanced, it can require the manufacturer to include additional objective and scientifically sound information or an objective statement prepared by FDA about the safety or effectiveness of the new use.

Manufacturers would have an ongoing responsibility to provide FDA with additional information about the disseminated new uses, and FDA could order the cessation of the dissemination if the additional information indicated that the "off label" use may not be effective or may pose a significant risk to public health.

Written comments on the proposal, which will soon be published in the Federal Register, should be sent during the next 45 days to:

--Dockets Management Branch (HFA-305),

--Food and Drug Administration, 12420 Parklawn Drive, Room 1-23 Rockville MD 20857

Under FDAMA, the deadline for issuing a final rule is one year from enactment.

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SOURCE: Food and Drug Administration (FDA).

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