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The rapid growth of compounded products, including knockoffs of FDA-approved medicines, especially diabetes and anti-obesity drugs, is raising serious patient safety concerns. These concerns are exacerbated by an increase in bold and often misleading advertising and marketing strategies for compounded drugs that do not include information on the risks and side effects associated with the products. Here is what you need to know:
Compounded drugs are not FDA-approved medicines.
Despite claims, compounded drugs are not the same as FDA-approved products. The FDA does not review the safety, effectiveness or quality of compounded drugs. The FDA has even warned that “compounded drugs pose a higher risk to patients than FDA-approved drugs because [they] do not undergo FDA premarket review.”
Conversely, FDA-approved drugs are subject to the Agency’s gold standard review process, meaning the FDA verifies the safety, efficacy and quality of the medicine. Manufacturers of FDA-approved medicines are subject to rigorous post-marketing requirements for monitoring and reporting safety issues as compared to compounders.
What is compounding and when is it appropriate?
Compounding is generally a practice in which a licensed pharmacist or a licensed physician mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. Compounding may be appropriate for a patient who cannot be treated with an FDA-approved drug or can play a role when FDA-approved medicines are not available during a drug shortage.
Federal law governs compounded drugs under the Federal Food, Drug and Cosmetic Act: Sections 503A and 503B, applying to compounding pharmacies and outsourcing facilities.
The illusion of personalization.
Some compounding pharmacies are mass compounding drugs with different strengths, routes of administration and ingredients than commercially available drugs, even when FDA-approved medicines meet patients’ medical needs. Nationwide compounding of these drugs under the pretense of making ‘personalized’ drugs is unsafe, inconsistent with relevant laws and undermines the innovation ecosystem that brings new, FDA-approved medicines to the U.S. market.
There are real risks and real harm.
Even with known significant underreporting, there are still numerous reports of impure, contaminated or substandard compounded drugs causing serious harm. Some compounders are making mass quantities of drugs with unapproved active pharmaceutical ingredients from other countries which aren’t compliant with FDA regulations, often due to their manufacturing and quality control issues.
History reminds us what is at stake. In 2012, a fungal meningitis outbreak linked to contaminated compounded epidural injections killed more than 60 people and sickened hundreds more. That tragedy led to reforms like the critically important Drug Quality Security Act—but today’s surge in bulk knockoff products, and the demand for them from patients, shows those lessons are fading. Undermining the laws that help protect patients is dangerous and would make it easier for rogue actors to skirt safety.
Oversight and enforcement are needed.
Some compounders are exploiting the system, misleading patients and putting their health at risk to make a profit.
Increased FDA oversight of compounders is critical. We encourage the FDA to hold bad actors accountable, in turn reducing risks to patients’ health and preventing harm associated with compounded drugs.
Kristen Booze
Kristen Booze is a Director on PhRMA’s Public Affairs team, where she leads communications strategies on scientific and regulatory issues related to the biopharmaceutical industry. Prior to joining PhRMA, Kristen most recently served as Deputy Director of the Division of Health Communication in FDA’s Center for Drug Evaluation and Research (CDER). In this role, she advised on strategic communications and messaging related to drugs. Kristen served as a federal government communicator for twelve years. She holds a B.S. in biology from SUNY Geneseo and an MPH from The George Washington University. Outside of work, Kristen spends her time refereeing her three boys with her husband and squeezing in some early morning exercise.
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