Speeches & Testimony
Pew Comments on FDA Guidance Document Concerning Biological Products
The Pew Charitable Trusts offered comments on a revised draft guidance document issued by the Food and Drug Administration in January 2017, which would allow certain manipulations of commercial biological products outside of the labeling instructions in order to meet a clinical need. The revised proposal improves upon an early draft by creating an option for compounders that comply with high quality standards to set longer beyond-use dates supported by testing, which strikes a reasonable balance between the practical advantages of extended dating and the need to ensure product sterility.
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Rules for Interstate Delivery of Compounded Drugs Prevent Widespread Distribution of Dangerous Medications
Contaminated and improperly stored injectable products from a Massachusetts-licensed compounding pharmacy caused a fungal meningitis outbreak in 2012 that killed dozens of people and injured hundreds more. Notably, while patients were harmed in 20 states, none lived in Massachusetts, where the pharmacy was located. Read More
Five years after enactment of the Drug Quality and Security Act (DQSA) in response to a catastrophic fungal meningitis outbreak caused by contaminated compounded medications, illnesses and deaths linked to contaminated drugs continue to occur. The FDA regulates compounded drugs—medications for patients with clinical needs that cannot be met by commercially available... Read More
Medical providers may at times treat patients whose needs cannot be met by commercially available, Food and Drug Administration-approved products, such as a child who requires a liquid form of a medicine approved only as a pill. In these situations, providers can instead prescribe compounded drugs, which are made by pharmacists or physicians instead of drug manufacturers. To protect patient... Read More