Julie Dohm is Of Councel at Covington & Burling based in Silver Spring, Maryland and focuses on regulatory matters for pharmaceutical and biotechnology companies. Between 2016 and 2019, Julie served as the lead on compounding for the U.S. Food and Drug Administration (FDA). Julie discusses the differences between FDA approved therapies versus compounded drugs. These differences and risks should be considered by physicians before prescribing compounded drugs to patients.

The United States health care system has access to the safest and most advanced pharmaceutical system in the world, overseen by the FDA's Center for Drug Evaluation and Research (CDER). The FDA and CDER evaluate new drugs before they can be sold and provides doctors and patients the information they need to use therapies effectively. The center ensures that drugs, both brand-name and generic, work correctly and that their health benefits outweigh their known risks.

Julie Dohm explains that pharmaceutical companies seeking to sell a drug in the United States must first test it and prove the drug is safe and effective for its intended use. Before a drug can be tested in humans, the drug is studied in the laboratory and in animals to understand how the drug works and whether it's likely to be safe and effective in humans. Next, a series of tests in people is begun to determine whether the drug is safe when used to treat a disease and whether it provides a real health benefit. The drug development process can take over 10 years, and the outcome is that physicians and patients can feel comfortable that the FDA-approved therapy is well tested, safe, and effective for it's intended use.

Compounded drugs are not FDA-approved, which means that FDA does not verify their safety or effectiveness. they do not have the same safety, quality, and effectiveness assurances as FDA approved drugs. Unnecessary use of compounded drugs can needlessly expose patients to potentially serious health risks.

For more information about the drug development and approval process, see How Drugs Are Developed and Approved.

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