Drug approval process removal from market

The second major change enacted under the 1962 amendment was the change in the approval process from premarket notification to a premarket approval system. Under the terms of the 1938 law, an NDA would take elfect automatically if the FDA did not respond. For example, the only reason thalidomide was not approved was because Dr. Kelsey returned the application to the sponsor with a request for more information. In contrast, the 1962 law required affirmative FDA action before a drug could be put on the market. Under the terms of the 1962 amendments, the FDA was also empowered to withdraw NDA approval and remove the drug from the market for a variety of reasons, including new evidence that the product was unsafe or that the sponsor had misrepresented or under-reported data. 

Despite the rigorous process for drug approval and regulation, several important medications have been removed from the market because of serious ADEs over the past 30 years. Examples of serious but uncommon effects include acute flank syndrome associated with suprofen," the gastrointestinal effects associated with nonsteroidal anti-inflammatory drugs (NSAIDs) in the elderly," troglitazone and the risk of hepatotoxicity," and the adverse effects of cisapride... 

After reviewing all comments in response to the proposed order, a Tentative Final Monograph is published that establishes conditions for OTC drugs considered safe and effective and not misbranded. Interested parties are invited to comment on the TFM and information used to establish the FM. Upon publication of the FM, all products not conforming to the safety and efficacy requirements are removed from the market or evidence must be provided to prove that the product now meets the requirements for safety and efficacy specified in the monograph. This information must be submitted through the new dmg approval process, as discussed later in this chapter. 

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