The AER law amended the federal Food, Drug and Cosmetic Act to require the reporting of “serious” adverse events for both over the counter (OTC) drugs and dietary supplements. It requires “responsible persons” to submit any serious adverse event to the U.S. Food and Drug Administration (FDA) within 15 business days of learning about it. The responsible persons must submit any additional information concerning the adverse event of which it becomes aware within one year of its initial AER (within 15 days of receiving the additional information).
While the industry has maintained that dietary supplements are generally safe, the withholding and subsequent release under subpoena of several thousands of AERs relating to ephedra has led some in Congress to question whether there are thousands more adverse experiences that are going unreported because the current system is voluntary.
The AER law became effective one year after its signing by the president on December 22, 2007.
Does the law cover any reaction or complaint to any product I carry or manufacture-no matter how minor?
No. The AER law will not require reporting of all complaints, but instead will be limited to serious adverse events. “Serious” adverse events as defined in the law are: (1) death; (2) a life-threatening experience; (3) inpatient hospitalization; (4) a persistent or significant disability or incapacity; (5) a congenital anomaly or birth defect; or, (6) require medical or surgical intervention to prevent the above outcomes. Although the AER law only requires that reports of “serious” adverse events be submitted to the FDA, records of other types of product complaints or adverse events must be maintained for a period of six years by the responsible person.
As a retailer, what am I required to do under this AER law if a customer of mine has an adverse reaction to one of the products I carry?
If a complaint is received on a branded product, retailers will not have any obligation to report such adverse events to FDA. The manufacturer of the product, in this case the “responsible person,” will have the legal responsibility of reporting serious adverse events in connection with these products.
If a complaint is received on a private label product sold by the retailer, defined as “distributors whose name…appears on the label,” the retailer will have to make a decision about who will be the “responsible person” for the purposes of the AER law. Such retailers will have to make a choice to either assign the reporting responsibility to the manufacturer of their private label products, or to report serious adverse events themselves.
I'm a retailer. What would I be required to do in the following situation: a customer comes into the store and says they had to go to the hospital because of supplement they bought from me?
What you describe would fall under the definition of “serious.” If the product is not marketed under your name, you are not required to do anything. If it was your private label product and you and the manufacturer have agreed that such complaints would be handled by them, it could be as simple as providing the phone number of the manufacturer to the customer. In this situation, there also would be no recordkeeping requirements for the retailer.
If as a retailer you have elected to handle adverse event reports yourself, you would then be required to follow the reporting and recordkeeping steps as outlined in the law.
FDA’s previous system, the CFSAN Adverse Event Reporting System (CAERS), was voluntary. The AER bill makes reporting serious adverse events a legal requirement for “responsible persons” as discussed above.
Yes. Throughout the legislative process, NPA and other associations were given the opportunity to provide input about the AER law. The NPA team took care to protect retailers and the industry by emphasizing that a meaningful and fair AER law must: (1) be limited to serious adverse events, not require reporting just any complaint; (2) include OTC drugs; (3) not force retailers to report; (4) be limited to products sold in the U.S.; (5) allow third parties to report or evaluate claims; and (6) include a state preemption provision. Because these objectives were achieved and for some of the reasons discussed below, the NPA Board of Directors decided to support the AER law.
The AER law provides explicitly that the submission of any serious adverse event report shall not be construed as an admission that the product caused or contributed to the adverse event or otherwise caused or contributed to a death, serious injury or illness. Keep in mind that anyone, including trial attorneys, could access dietary supplement adverse event reports under the previous CAERS program.
These increased responsibilities on the part of manufacturers will benefit the industry in the long run in a few ways. It will thwart continuing press articles stating that dietary supplement safety is not monitored; it will help improve the public perception of the dietary supplement industry by demonstrating that, contrary to media reports, the industry is regulated; and over time, the recordkeeping and reporting requirements will substantiate what many in the industry have been saying: that the safety record of dietary supplements compares favorably to other health-related products.