HOW ARE DRUGS WITHDRAWN FROM THE MARKET?
Once a drug is approved, the manufacturer has an obligation to conduct analysis of what is called “post-marketing data.” This data is complied from further tests on the drug and from doctors and patients who are using the product, and gives the manufacturer a developing picture of the drug’s safety record. But many times, this new data isn’t finding new risks, but only confirming what was seen in early tests. Many times, manufacturers will see negative results in pre-approval trials, but will adjust the data before submitting it to the FDA to ensure approval. Post-marketing data is harder to explain away. Typically, it is material like this that attracts scrutiny. When the FDA learns of further risks with a drug, it usually convenes a group of experts to analyze the data and make a recommendation. This is called an “Advisory Committee.” The recommendations of these committees usually are what motivates the withdrawals of drugs. Many times, manufacturers will realize that a recommendati
