P98-17 FOOD AND DRUG ADMINISTRATION FOR IMMEDIATE RELEASE Print Media: 301-827-6242 June 5, 1998 Consumer Hotline: 800-532-4440
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:
A firm that has not submitted a supplemental application for the new use could begin disseminating information if it has:
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.