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Cochran Firm Blog, Philadelphia

Does FDA Approval Mean That a Drug is Safe?

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FDA approval of a drug means that the data on the drug’s effects have been reviewed by the FDA’s Center for Drug Evaluation and Research (CDER), and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. Unfortunately, FDA approval does not guarantee 100% safety.

CNN reported that between 2001 and 2010, about a third of the drugs the FDA approved had problems after reaching the market. Only three drugs were actually pulled from the market, but others required the addition of boxed warnings and warranted FDA safety communication. The FDA ensures that all the drugs they approve undergo lifetime monitoring, but it’s important for consumers to note that there are still risks involved with taking a drug even if it is FDA approved. Many believe the added pressure to speed up the approval process in general is to blame for the increased amount of FDA approved drugs resulting in safety issues after they hit the market.


Standard Approval Process

The approval of a drug generally follows a structured framework that includes three phases:

  1. Analysis of the target condition and available treatments – reviewers analyze the condition or illness for which the drug is intended and evaluate the current treatment for landscape, which provide the context for weighing the drug’s risks and benefits
  2. Assessment of benefits and risks from clinical data – reviewers evaluate clinical benefit and risk information submitted by the drug maker, taking into account any uncertainties that may result from imperfect or incomplete date
  3. Strategies for managing risks – risk management strategies include an FDA approved drug label, describing the both drug’s benefits and risks along with how risks can be detected and managed


Accelerated Approval Process

The Accelerated Approval process was first established in 1992. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. Approval is also based on a surrogate endpoint or measurement at which clinical benefit is predicted.