Mandatory Supplement AE Reporting Possible Under Current Law – AHPA

FDA has the authority to require mandatory adverse event reporting for dietary supplements under current law, the American Herbal Products Association maintains in a recent citizen petition.

"AHPA believes that FDA has ample legal authority to require adverse event [reporting] under existing law [and] encourages FDA to reexamine its position" on the issue, the trade association says.

"The submission of adverse event reports would enable [the agency] to determine at the earliest possible time whether to request a dietary supplement manufacturer or distributor to recall a product, change its labeling, or to request that the Department of Justice take seizure or injunctive action," AHPA contends.

The trade group adds that information gained from AERs "would allow FDA to ascertain how best to use its scarce enforcement resources" for supplements.

As a result, AHPA requests that the agency issue a proposed rule requiring dietary supplement firms to submit all serious adverse event reports they receive to FDA, similar to "the process for reporting [adverse events] for prescription drugs."

The proposed rule would require "manufacturers, packers and distributors of marketed dietary supplement products to establish and maintain records and make reports to [the agency] of all serious adverse dietary supplement experiences...that are associated with the use of their products," AHPA notes.

Serious adverse experiences would be defined as "occurring at any dose that results in...death, a life-threatening adverse [incident], inpatient hospitalization, a persistent or significant disability/incapacity or a congenital anomaly/birth defect."

Serious supplement AEs also may take place "when, based upon appropriate medical judgement, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition," AHPA continues.

Under the trade group's proposal, "any person whose name appears on the label of a marketed dietary supplement product as its manufacturer, packer or distributor shall report to FDA" each AER it learns of within 30 days; Rx drug companies have 15 days to submit AERs.

The relevant party would then have to investigate the event and its potential causes and submit a follow-up report to the agency within another 30 days. The firm also would have to maintain records of all AERs "for a period of 10 years."

With regard to FDA's retention of the AERs, the petition states any adverse event monitoring system for dietary supplements operated by the agency should provide the same privacy protections "that are now provided to pharmaceutical and medical device manufacturers, i.e., that the names and identifying information of adverse event reports not be disclosed by FDA or by any company."

Although it "does not oppose the public availability of information regarding dietary supplement AERs," AHPA believes the information should be handled in the same manner for supplements as it is for Rx and OTC drugs.

The trade association previously has criticized FDA's practice of making summary dietary supplement AERs available on its Special Nutritional Adverse Event Monitoring System Web site, while similar summaries of Rx adverse events are not made publicly available (¹ (Also see "Mandatory AE Information Requirements Needed For CAERS Filings – AHPA" - Pink Sheet, 28 Oct, 2002.), p. 14).

The agency is currently in the process of replacing SN/AEMS with the more comprehensive CFSAN Adverse Events Reporting System.

AHPA's citizen petition was filed in the midst of increasing skepticism about the safety of dietary supplements and is likely meant to deflect some of the criticism that recently has been leveled at the industry. AHPA has maintained that mandatory adverse event reporting would not harm the botanicals industry because there are few serious AEs associated with the products (² (Also see "Serious Herbal AEs Deemed Negligible; AHPA Urges Mandatory Reporting" - Pink Sheet, 7 Oct, 2002.), p. 3).

The trade group noted that while its members, several of which manufacture ephedra products, broadly support the citizen petition, universal agreement on the issue could not be obtained.

On March 26, Sen. Richard Durbin (D-Ill.) introduced the "Dietary Supplement Safety Act," which, among other things, would require that supplement firms notify FDA of adverse event reports within 15 days of receiving them (see ³ (Also see "Supplements Containing Stimulants Would Need Preapproval Under Durbin Bill" - Pink Sheet, 31 Mar, 2003.) ).