Consumer Group defends allergy sufferers
Find a Conversation
|Tue, 04-01-2003 - 11:13am|
NCL to FDA: Hasty Rx-to-OTC Switches Bad Medicine
Thursday March 20, 3:00 pm ET
Letter from Nation's Oldest Consumer Advocate Urges Agency to 'Place Patient Safety First'
WASHINGTON, March 20 /PRNewswire/ -- The National Consumers League has called upon Congress to conduct hearings to ensure that the U.S. Food and Drug Administration (FDA) adheres, in practice, to its longstanding policy of providing sufficient time for post-market surveillance of prescription drugs before making them available over the counter. The current FDA policy is to withhold approval on a switch of a prescription drug to OTC status for typically five or more years -- until there is adequate marketing experience as a prescription product to ensure that patient and public health will not be put in danger. If followed, the policy ensures that a prescription drug has seen enough physician-supervised use that potentially serious adverse reactions and side effects would be detected before it is made available as an option for self-medication.