The compliance of companies newly subject to adverse event reporting and record-keeping requirements will likely be evaluated by FDA on a "performance-oriented basis," said Rick Kingston, PharmD, president and senior clinical toxicologist at SafetyCall International, an adverse event call center.

Signed into law in late 2006 and set to go into effect in December, the "Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006" (S 3546) establishes mandatory reporting of serious adverse events for dietary supplements and monographed OTC drugs.

Sunscreens, antiperspirants and treatments for dandruff and acne are among products regulated under OTC monographs (¹ Also see "Monograph OTCs Subject To Adverse Event Reporting Under Hatch Bill" - HBW Insight, 18 December, 2006., p. 4).

Kingston, who consulted on the bill, spoke Jan. 11 at a United Natural Product Alliance seminar in Salt Lake City, Utah. The seminar was held to develop companies' understanding of the bill and its implications.

Kingston maintained that while report language written by the Senate Health Committee often times leaves little room for interpretation, in this case FDA has a "fair amount of leeway in many respects for certain nuances in the way that they issue their guidance."

FDA is "going to set up what the guidelines are. There's going to be interpretation that takes place on both sides. It's not going to be as strict as you might think in some areas," Kingston said.

The agency has until August to release a guidance to industry on the reporting and record retention requirements (² 'The Rose Sheet' Jan. 1, 2007, In Brief).

According to Kingston, now that the bill has been signed, Congress must forward it, along with the accompanying report language, to FDA where the agency's legal counsel will interpret the law and the congressional intent behind the bill.

Following this review, FDA's Center for Drug Evaluation and Research and Center for Food Safety and Applied Nutrition will develop a guidance for the regulated industries, he continued.

"Having seen a number of these different bills for spontaneously reported data go into effect in my 28 years in clinical toxicology, poison control and adverse event reporting," and knowing the way FDA and its medical officers "typically" look at such regulations, Kingston expects the agency to evaluate companies' behavior from a "standard-of-care" and "practice-oriented" perspective.

This performance-oriented approach will be particularly visible in two areas, he said.

First, companies will be expected to use "reasonable medical judgment" in determining whether an adverse event qualifies as "serious" and therefore warrants reporting to FDA within 15 days after notification of the event.

Second, FDA will focus on the six-year record retention requirement for adverse events, including non-serious events.

According to the legislation, the responsible party must maintain records related to "each report of an adverse event," Kingston said. An adverse event is "any health-related event associated with the use of a [product] that is adverse," he noted.

"When someone's talking about a stomachache or cramps, that's still considered to be an adverse event, and it's still the manufacturer's responsibility to record each and every one of those particular events and maintain those associated records."

"If you look at it from an epidemiologic perspective, you can't collect sentinel events by asking people only to report sentinel events. ... What you have to do is collect all events, look at them and identify those particular events that potentially" indicate a larger problem, Kingston said.

"So, there's going to be a lot of nuances in terms of how you look at the entire population of adverse events that come through your system."

If a consumer calls with an imprecise adverse event, "you're ... at least [to] have communication with that person to understand what really happened, and then do some additional questioning so you fully understand what they're saying," Kingston said.

Additionally, he said FDA is going to expect firms to outsource AE analysis and reporting responsibilities to a third-party if they deem themselves ill-equipped to competently fulfill the obligation on their own.

"The committee recognizes that many manufacturers have indicated they would contract the reporting function to a third party which has greater expertise. ... I think what they're also pointing out [is] there's this underlying theme that this is going to be a performance-oriented type of regulation," he said.

"I don't see the FDA going out and trying to nick and ding people on single incidents that they may have misidentified" as non-serious, Kingston said. However, if a major complication occurs and the authority discovers the person was using a certain product, FDA or local authorities will "go back ... and look at your records of all adverse events."

If a pattern of adverse events exists, the authority may conclude that the responsible party had "sufficient information" to recognize that the complication could occur, he said.

Kingston also expects that the performance-oriented aspect will be evident in the area of company accessibility.

"If you look at what the intent of Congress is, it's that they want all potentially reportable events to end up at your doorstep in some shape or form," he said. "There's going to be an expectation that if a consumer wants to make a report to you ... [you] have some type of system in place to make that happen."

FDA's guidance document may address reporting of adverse events via e-mail and Web contact forms, Kingston said. "E-mail and Web contact [are] one of the most common [types of communication], and most of the other adverse event reporting systems that I've seen take this into account."

Additionally, this expectation places a high standard on employee training.

"You're going to have to have to train everybody in your organization [who] may potentially" hear about an adverse event, Kingston said. Companies need "to make sure that nothing slips through the cracks that [could have] potentially severe consequences.

- Katia Fowler

Expert Gives Lowdown On Adverse Event Reporting Bill For Monograph OTCs

More from Archive

More from HBW Insight