Date: Feb 15, 2007
President Bush has signed the "Dietary Supplement and Nonprescription Drug Consumer Protection Act," adding new sections 760 and 761 to the Federal Food, Drug, and Cosmetic Act (FDC Act). When this legislation takes effect on December 22, 2007, it will require "responsible persons" to submit to the Food and Drug Administration (FDA) "serious adverse event reports" (SAERs) received for finished nonprescription (i.e., over-the-counter (OTC)) drug products and dietary supplements, along with a copy of the product's label. Nothing would prevent the voluntary submission of adverse event reports (AERs) that do not rise to the level of being "serious."
Products labeled on or after December 22, 2007, will need to include a domestic address or domestic phone number through which the responsible person can receive reports of adverse events. Products that do not include such information (including those imported from foreign manufacturers) will be deemed to be "misbranded" and subject to regulatory action by FDA. Records of all adverse events (whether serious or not) will need to be kept for six (6) years and made available for review by FDA. Congress has also taken steps to ensure that any State or local AER systems are consistent with the new Federal requirements. In addition, the submission of an AER is specifically prohibited from being construed as an admission that the product involved caused or contributed to the adverse event.
The new AER systems will require companies to develop and implement new systems to monitor adverse events and determine which ones must be submitted to FDA. Within 270 days, the Agency is required to issue guidance on the minimum data elements to be included in an SAER, although FDA is likely to provide guidance on other aspects of the requirements as well. The major dietary supplement and OTC drug trade associations strongly supported the legislation, since it is expected to increase consumer confidence in the safety of these products (and dietary supplements in particular) by providing FDA with the means to monitor potential health risks associated with their use. The new requirements are discussed in more detail below.
A "serious adverse event" is an adverse event that (A) results in (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in clause (A). New FDC Act §§ 760(a)(3) and 761(a)(2). The Senate report accompanying the legislation acknowledged that many responsible parties may not have the medical expertise needed to determine whether a particular adverse event is "serious." In those cases, the responsible parties may contract with a third party with greater medical expertise, but the "responsible person" named on the product label "still maintains ultimate responsibility for reporting under the law." Senate Report No. 109-324, at 8.
A "responsible person" is required to submit to FDA SAERs associated with a Covered Product when used in the United States (although nothing prohibits the voluntary submission of AERs that are not "serious"). Information on adverse events occurring outside the U.S. need not be reported to FDA, even if they are "serious." The new legislation defines the "responsible person" as the manufacturer, packer, or distributor whose name is required to appear on the label of a Covered Product marketed in the United States, under sections 502(b)(1) or 403(e)(1) of the FDC Act. New FDC Act §§ 760(b)(1) and 761(b)(1).
Each SAER is to be submitted through FDA's MedWatch program. Although the legislation does not specifically indicate, it is expected that submitters will use form FDA 3500A (for mandatory reporting). Additional information about the MedWatch program, including copies of form FDA 3500A and instructions for completing it, can be found at the following link. http://www.fda.gov/medwatch/report/mfg.htm. FDA is authorized to modify the MedWatch form to address the Covered Products. New FDC Act §§ 760(d) and 761(d). Since neither dietary supplements nor OTC drugs are described on form FDA 3500A, it is reasonable to expect that FDA will amend the form in the future, although this is unlikely to occur before the mandatory reporting obligation goes into effect.
The new legislation also includes a preemption provision which prohibits any State or local government from "establish[ing] or continu[ing] in effect any law, regulation, order, or other requirement, related to a mandatory system for [AERs for Covered Products], that is different from, in addition to, or not otherwise identical to," the new Federal requirements. New FDC Act §§ 760(h)(1) and 761(h)(1). Prior to the enactment of the new AER legislation, several States had proposed implementing their own AER systems. Given the potential concerns about the burden of complying with several different AER systems in the future, the preemption section eliminates that possibility.
FDA may share AERs and related information with appropriate State and/or local health officials, provided that "personally identifiable information" is not released. In addition, State and local governments are prohibited from using any AER information received from FDA in a manner that construes the report as an admission that the Covered Product caused or contributed to the adverse event. New FDC Act §§ 760(h)(2)(C) and 761(h)(2)(C).
Conclusion Overall, the new AER legislation will impose additional burdens on manufacturers, packers, and/or distributors of OTC drugs and dietary supplements. Companies will need to develop and implement appropriate procedures, train personnel, and/or determine whether they wish to contract out some part of the AER review process. Responsible persons will need to determine what domestic address and/or phone number will be used to receive adverse event information. Since products labeled after December 22, 2007, will need to include this information, affected companies likely will need to make decisions in the relatively near future to make certain that compliant labels are ready for use by the deadline.
For further information about this issue or FDA's regulation of OTC drugs and dietary supplements generally, please contact Frederick A. Stearns at 202-434-4288 or via e-mail at firstname.lastname@example.org.