In 1982, FDA issued a guidance on the handling of solicited and unsolicited requests for information from the regulated industry. FDA has indicated that they intend to update that guidance. Until now, companies have been able to respond to unsolicited requests even if the response contained off-label information. It would appear that FDA has become suspect of some of the suppliers of such information within the company.

In the past, the source had been the medical department. FDA has questioned the qualifications and titles of persons providing such information today and are also questioning the venue, i.e. the field, the convention hall, a seminar, etc. The suggestion is that there is a connection between the provider and the promotion activities of the company.

ISSUES

* Healthcare providers have an essential need to obtain critical information from manufacturers for proper diagnosis and treatment. Restricting this communication channel will have an adverse effect on patient care.

* There is a moral obligation for companies to answer questions about their products regardless of the circumstances surrounding the transmission or the responders company position as long as the information is truthful, accurate, and responsive to the question posed.

* The FDA Modernization Act confirmed the companies' right to respond to unsolicited requests. In light of this, why is it necessary to revise the 1982 guidance?