The AER Law is Upon Us

Reviewing some last minute items before adverse event reporting becomes law.

By Todd Harrison

In the June issue of Nutraceuticals World, I wrote a column on the new adverse event reporting (AER) requirements for dietary supplements. Because the effective date is December 22, 2007, I decided that it is important to review some of the major points of this legislation. I’ve also added a new section regarding how to have your customer service representatives handle these types of calls if you choose to do the intake yourself instead of referring the call to a third party service.

But just as this column went to press, FDA issued its long awaited guidance document, so this article while extremely accurate does not fully explore the ramifications of this guidance. For instance, FDA has indicated that companies should follow up with a consumer’s healthcare provider to get more information. This may very well raise serious privacy issues. Indeed more analysis of the new guidance is important. (Further analysis of the new AER guidance will appear in the November online edition of Nutraceuticals World. For more information see box on page 26.)

The Act imposes three main re-quirements 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 (using the agency’s “MedWatch” form) any serious adverse event associated with the product—serious is important for purposes of defining what types of events must be reported to the agency as opposed to the record keeping provisions—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” using the agency’s “MedWatch” form, accompanied by a copy of the product label within 15 business days of receiving the report. The Act considers a “serious adverse event” to be one that results in any of the following:

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

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 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 regardless of whether or not the reporting consumer sought medical care or otherwise had proof of a serious adverse event.

The Act also includes a provision that makes 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.

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.

Customer Service Representatives

The key to a successful AER compliance program is proper training. Ideally, FDA would prefer to have healthcare professionals handle these calls. For larger companies, this may be a reasonable option because they can outsource it to consultants that are set up to handle such calls. However, outsourcing does have its issues. First, is the cost. Second, it adds another layer of monitoring over the process.As a result, outsourcing may not be desirable for some of the smaller companies. In this case, it is important to properly train personnel to handle an AER report and to know the difference between a serious AER, a non-serious AER, and a customer complaint.

Customer service representatives (CSRs) should follow an adverse event intake script and form developed for this purpose. It is important that individuals handling the initial call use the script and form, which permits a narrative, but does not allow the customer to go off on a tangent. It should also capture information regarding use of other medications and dietary supplements, as well as what the person consumed over the last 24 hours. In this regard, the script and form should be developed to elicit easy-to-understand but simple answers from the caller that capture the relevant information necessary to determine whether there is a serious adverse event and to properly fill out MedWatch Form 3500A. Some of the minimum data elements needed to report an adverse event include:

• identify the injured person
• identify the person reporting the event
• identify and provide contact information for responsible person (i.e., manufacturer, packer or distributor submitting the serious adverse event report to FDA)
• identify the dietary supplement or supplements involved in the adverse event
• provide a description of the adverse event
- I tookand it caused abdominal cramping.
- I tookand now I feel bloated/flatulent.
- I was hospitalized after taking
for vomiting blood.
- I had a [medical event, e.g., stroke] and my doctor says it was due to my dietary supplement.
- I tookand now my breath smells funny (garlicky, fishy, metallic, etc.).
- I am also taking coumadin and a multivitamin.
- I had sushi for lunch.

The CSR will also need to know when not to use the adverse event script, or for those companies that are utilizing an AER reporting service, to know when not to transfer the call. The following are examples of complaints that are not considered serious adverse events:

I tookand it didn’t work for me the way it was supposed to/didn’t work for me.
I don’t like the way it tastes [non-safety related].
I don’t like the way it smells [non-safety related].
I find it hard to swallow.
I don’t like the wayis packaged.

It is important to remember that the determination of whether an AER is serious must be viewed through the eyes of the consumer. Thus, while it is imperative to capture information regarding use of other supplements and medications, it is not up to the company to decide whether the AER is related to its product. Rather, if the customer thought that the supplement caused their stroke, under the law that is considered a serious adverse event.

Record-Keeping: All Adverse Events

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
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 states 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 suggested that labels might 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.NW