Since 2006, there has been a labeling redesign from the past FDA drug labeling program. Drug labeling is now presented as a Highlights section on the first page or more of the professional labeling, followed by the Full Prescribing Information (FPI). The Highlights allows professionals to see the most important information in one ‘sweep’ of review and also contains cross-references to the additional information contained in the FPI. The FPI was revised to streamline the meaning, arrangement and data in a clearer and more usable format. Some older drugs have been ‘grandfathered’ and appear in the previous drug labeling format.
FDA Approvals: What this means
FDA approvals of drugs means that the data collected in examination of the drug have been reviewed by the Center for Drug Evaluation and Research (CDER). An approved drug has been determined to provide greater benefit to the intended population than its known and potential risks at that time of review.
FDA reviewers analyze the proposed treatment (indication) and current disease treatment landscape by analyzing the drug’s intended use. The FDA review process provides an environment for weighing the risks and benefits of the drug in relation to the current state of the scientific evidence.
In general, FDA expects (often requires) that the drug sponsor will submit the results of two well-designed clinical trials, making sure that the findings of the first trial are reproducible and not the result of chance or bias. In some cases, especially if the disease is rare and many tests are not possible, conclusive evidence from smaller clinical trials may be sufficient. Evidence that a drug will benefit the target population should outweigh any risks and uncertainties.
In some cases, the approval of a new drug can be ‘accelerated’. More rapid approval can be used for promising treatments that treat the acute or life-threatening conditions and provide therapeutic benefits over the available treatments. This approach sometimes allows the approval of a drug that demonstrates an effect on a “surrogate endpoint” or a previously occurring medical endpoint that is reasonable to predict a longer-term clinical benefit. This approval pathway is particularly effective in treatments for disease that requires a long time to measure its effect. After entering the pharmaceutical market, often the sponsor must conduct post-marketing clinical trials to verify and describe the benefits of the drug. FDA approval may be revoked if further tests fail to verify the predicted medical benefit.
Strategies for Risk Management – All Drugs Have Risks. Risk management strategies include an FDA-approved drug label that clearly describes the benefits and risks of the drug, and how to identify and manage the risks. Sometimes, more effort is needed to manage risks especially as they can change over time in the expanding marketplace. In these cases, a sponsor may need to implement a risk management and mitigation strategy (REMS).
Many times, consultants can help with reviewing and revising drug labeling. Experts, such as Biotech Research Group, can also help evaluate risk and safety of products as well as the associated REMS programs. For any other inquiry – connect with Pharmaceutical consultants.