Reviewing New AER Requirements
Knowing the details of the new AER law is essential for all dietary supplement companies.
By Todd Harrison
The Dietary Supplement and Nonprescription Drug Consumer Protection Act (S.3546) passed late last year and will go into effect in December. Therefore a review of the law’s key provisions is in order.
The law covers all dietary supplement and over-the-counter (OTC) drug manufacturers and distributors. Manufacturers and distributors should begin to take steps to implement procedures to comply with the law.
The Act imposes three main requirements concerning adverse event reporting. First, it requires that the manufacturer, packer, or distributor whose name appears on the product label (referred to as the “responsible person”) report to FDA (on the agency’s “MedWatch” form) any “serious adverse event” associated with the product, along with a copy of the product label, within 15 business days of receiving the report. Second, the responsible person must maintain a record of all adverse events, whether serious or not, for six years from the date of receipt of the report. Third, product labels must include the responsible person’s domestic street address or phone number to which people may send reports of adverse events.
Reporting Serious Adverse Events
The Act requires that the manufacturer, packer, or distributor whose name appears on the product label (referred to as the “responsible person”) report to FDA any “serious adverse event” on the agency’s “MedWatch” form (accompanied by a copy of the product label) within 15 business days of receiving the report. The Act defines an event as a “serious adverse event” if it results in any of the following:
1. death;
2. a life-threatening experience;
3. inpatient hospitalization;
4. a persistent or significant disability or incapacity; or
5. a congenital anomaly or birth defect.
In addition, an adverse event is deemed “serious” if it requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of the above outcomes.
While not included in the language of the Act as passed, the Senate HELP (Health, Education, Labor, and Pensions) Committee stated that when a report is received from a consumer who believes that he or she has experienced a serious adverse event consistent with the factors listed above, it is the responsibility of the entity taking the report to forward the report to FDA whether or not the reporting consumer sought medical care or otherwise had proof of a serious adverse event.
The Act also includes a provision making it a violation of the Federal Food, Drug and Cosmetic Act for anyone to submit a false report to a responsible person, and for any responsible person to submit a false report to FDA.
Reporting New Medical Information. The filing of the serious adverse event report will trigger an additional requirement. For one year from the date that the initial report is filed, the responsible person will have an obligation to submit to FDA any “new medical information related to” the report within 15 business days of receipt of the information.
Retailers. The Act permits retailers whose names appear on product labels as distributors (generally known as “private label distributors”) to, by agreement with the manufacturer or packer, make the manufacturer or packer the “responsible person.” As long as the retailer agrees to forward all reports of adverse events to the manufacturer, it will be the manufacturer’s responsibility to submit all reports to FDA. If no such agreement is reached, the retailer whose name appears on the label is responsible for submitting reports of serious adverse events to FDA. However, retailers that do not have private label products, that is, products bearing the retailer’s name, do not have a reporting obligation under the Act.
Record Keeping—All Adverse Events (Serious and Not Serious). The Act requires that the responsible person maintain a record of all adverse events, whether serious or not, for six years from the date of receipt of the report. For dietary supplements, an “adverse event” is defined as any health-related event associated with the use of a dietary supplement that is adverse. For OTC drugs, the definition of an “adverse event” is the same, but the bill identifies specific types of events that are considered adverse events:
1. an event occurring from an overdose of the drug, whether accidental or intentional;
2. an event occurring from abuse of the drug;
3. an event occurring from withdrawal from the drug; or
4. any failure in expected pharmacological action of the drug.
While not officially appearing in the text of the Act, the HELP Committee report explains that these records must be maintained regardless of the source of the report and regardless of any determination by the responsible person that the adverse event was not caused by, or associated with, the product. These reports must be made available to FDA for inspection upon request.
A Report is Not an Admission. The Act expressly provides that the submission of a report does not constitute an admission that the product caused or contributed to the adverse effect. In addition, the Act permits the responsible person to include with the report a statement denying that the report constitutes an admission that the product caused or contributed to the adverse effect. This statement will be included with FDA’s file. Hence, if in response to a Freedom of Information Act request, FDA releases the adverse event report file, it will also release the responsible person’s statement of denial.
Labels. The Act also requires that product labels include the responsible person’s domestic street address or domestic phone number to which people may send reports of adverse events. All products labeled on or after one year from the date of enactment of the Act must include this information. While considering the bill, the Senate HELP Committee contemplated that labels would also include an e-mail address. While that language is not in the Act as passed, it is possible that FDA will publish regulations concerning the inclusion of e-mail addresses in the future.
Importation. The Act authorizes FDA to refuse admission of nonprescription drug or dietary supplement products if (1) the label does not contain the name and domestic address or telephone number of the responsible person, (2) FDA has credible information indicating that the foreign manufacturer, packer, or distributor has not complied with the serious adverse event reporting requirements, or (3) the foreign manufacturer, packer, or distributor has not allowed FDA access to its records of adverse events. The Act permits the owner or consignee to submit an application for authorization to take actions to bring the products into compliance. If FDA grants the application, once a bond has been posted, the nonprescription drug or dietary supplement may be delivered to the owner or consignee to perform the actions specified in the authorization.
Preemption. The Act includes an express preemption provision. This means that no state or local government will be able to enact any law relating to a mandatory adverse event reporting system for nonprescription drugs or dietary supplements, if it is different from, or in addition to, this federal requirement. NW
References furnished upon request.