Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was introduced in June 2006 as a means of obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports. The AER legislation is set to come into practice by the end of 2007, meaning companies will have to have their reporting systems in place.
Following the bill's passing at the 'eleventh hour' in December, the responsibility of informing industry was left in the hands of trade associations. And AHPA is one of a few trade associations preparing tools for companies.
According to AHPA, its program is designed to help companies train staff and put policies in place. The association said its course explains the new law and educates companies about how to take reports of serious adverse events associated with their products.
To date, programs offered, or set to be offered by trade associations, have been required interested parties to attend seminars on site. AHPA's program could be of use to those companies not wanting to displace employees for educational sessions.
AHPA's course is sent by mail and includes materials and an audio CD. As such, it could be used to educate numerous employees at a time.
The association said the course shows companies how to handle an adverse event call using FDA's mandatory MedWatch form by asking callers the appropriate questions. As such, AHPA claims companies will be able to distinguish between a complaint and an adverse event.
It is expected that smaller companies will be able to contract out the fielding of such calls to an outside service. However, companies will need to clearly define who is responsible for receiving and investigating a call - be it a manufacturer, distributor or marketer.
The first group to host a seminar in the new year was the United Natural Products Alliance (UNPA), which held a workshop in January in Salt Lake City.
The Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) are hosting a one-day workshop for the dietary supplement and over-the-counter medicine industries on adverse events reporting. The workshop is scheduled for June 20 in Bethesda, Maryland.
Registration for CRN and CHPA members is $195, and $295 for nonmembers. AHPA's course materials cost $220 for members and $520 for non-members.