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. The partnership between NPA and Safetycall will offer reduced rates for services to association members, as well as include a number of educational events hosted by Safetycall so as to help companies adjust to the new regulation. "The recently offered guidance stressed the importance of using trained healthcare practitioners in meeting the regulatory requirements," said Daniel Fabricant, NPA vice president of scientific and regulatory affairs. NPA's CEO and president David Seckman opinioned during a panel held at SupplySide West in Las Vegas last week that when the AER bill comes into effect there will be an initial spike in incidences as reporting increases. However, he said this will then stabilize, so as to have a positive effect on the dietary supplement industry's image. "Then we will see that the baseline numbers will be low consistently," said Seckman. "We will then look to publicize this in industry." Safetycall claims to have more than 25 years experience in taking adverse events calls for the consumer product industry. The organization has medical professionals on staff who it says can add medical context to reported incidents and therefore put them in an appropriate context. A 60-day comment period from the US Food & Drug Administration (FDA) is currently underway concerning the draft guidance the agency published in October pertaining to the AER bill. Once the comment period closes and the final guidance is issued, industry is still free to follow the AER bill requirements through its own interpretation, as long as it does so legally.
The Natural Products Association (NPA) has announced a partnership with Safetycall to help its members prepare for the implementation of the adverse events reporting (AER) bill.