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Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.
A robust drug supply is crucial to ensuring that patients get the medicines they need. In a FDA Voice blog posted on FDA.gov, CAPT Valerie Jensen, Associate Director of the Center for Drug Evaluation and Research’s (CDER’s) Drug Shortage Staff, and Cynthia Schnedar, Director of CDER’s Office of Compliance, discuss how the different offices within the agency work together to combat drug shortages.
A variety of factors play into the problem of drug shortages, including manufacturing quality violations. One of these factors is unapproved prescription drugs; medications that are marketed in the United States but have not been approved by FDA. According to the agency, “physicians and other healthcare practitioners, along with consumers, cannot assume that all marketed drugs have been found by the FDA to be safe and effective.” FDA announced the Unapproved Drugs Initiative in June 2006. The goal of the initiative was to remove unapproved drugs from the market.
CDER’s drug shortages team works with the unapproved prescription drugs staff to encourage manufacturers to obtain approval for unapproved products. “At FDA, one task of our unapproved prescription drugs team is to identify these products, and encourage companies to remove unapproved versions from the market, and begin the application process to obtain FDA approval,” said Jensen and Schnedar in the blog. “These approvals are crucial for FDA: once a drug is approved, we know what ingredients are in the drug, how it is made, and that it has been shown to be safe and effective for its labeled use. Approval of formerly unapproved products also helps alleviate FDA’s concerns about a potential market disruption or shortage of these drugs, because the manufacturers of approved drugs have invested in a manufacturing process that helps to ensure the drug is produced the same way every single time, lowering the risk for shortage.”
Working together, these offices try to ensure a robust drug supply by sharing information about newly approved drugs with each other and with providers and by encouraging manufacturers “to apply for approval of generic versions of newly-approved drugs since this would be anticipated to foster competition and promote price reductions,” said Jensen and Schnedar.