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The PI Approval Process

How the Package Insert (PI) is developed during the drug approval process

The PI, or “Labeling Content” as it is called in legislation, is developed during the drug approval process. Once a drug has been identified as a candidate for market, it goes through three preliminary trail phases before the FDA approves it for release:

Phase I Tests for the safety of the drug are first conducted among a few healthy clinical volunteers, determining how the human body processes the drug.

Phase II Tests for the safety and effectiveness of the drug are conducted among patient volunteers (perhaps a few hundred) diagnosed with the condition or disease the drug will hopefully treat. If the study is “blinded,” neither the patient nor the research team knows which patients received the drug candidate.

Phase III Clinical trials enrolling hundreds to thousands of patients are conducted to provide in-depth information about toxicity, side effects and how the drug works. When these trials are concluded successfully – and sometimes the FDA’s scientific panels ask for additional studies before approving – the pharmaceutical manufacturer can request FDA approval to market the drug.

Before marketing the drug, the drug manufacturer must submit the text of the Package Insert (PI) to the FDA for approval. The give and take in this approval process often results in changes in how risks and side effects are communicated.

Phase IV After the drug is commercialized, information gathering and analysis continue, including not only controlled trials but also the data on safety and effectiveness generated by commercial use of the medicine in patient populations much larger than in clinical trials. Comparisons of effectiveness of the new drugs to other treatments available are often made. This Phase has resulted in significant actions by the FDA such as requiring MedGuides for particular classes of drugs, and manufacturers have even withdrawn some drugs from the market.