We’ve been observing the FDA crackdown on unapproved DESI and OTC drugs. The reason that Congress and FDA have made these moves is a concern for safety. Industry counters that these drugs have been used safely for years. Frankly, there is a lack of data to support either side. Approved drugs have always been subject to safety reporting. On December 22, 2006 the Dietary Supplement and Nonprescription Drug Consumer Protection Act was enacted to require manufacturers of unapproved OTC drug products to report serious adverse events. The reports must be made through MedWatch Form 3500A. FDA has issued a draft guidance and a resource list to assist manufacturers of unapproved nonprescription drugs report these adverse events.
These regulations became effective December 23, 2007. Merry Christmas!
Not mentioned in the guidance is the need for firms to have SOP’s to follow to implement the reporting requirements. Furthermore, since the firm will learn patient identities, all procedures must adhear to HIPAA regulations. For example, the firm’s person taking the calls must assure that the patient’s identity is not written down and shared with anyone except the person responsible for WedWatch reporting – even the QA person doing an investigation must not know the patient’s identity.
As a service to clients, Camargo handles adverse event and product complaints. It is not a simple, easy task to maintain adequate records that safeguard patient and reporter identity and yet provides the investigation needs of the FDA. We’d be glad to help set up and/or audit compliant systems.