Drug shortages mainly due to Quality issues – says Janet Woodcock

 

“To Help Reduce Drug Shortages, We Need Manufacturers to Sell Quality — Not Just Medicine”

By: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research

You might not always shop based solely on the lowest price. For instance, if you highly value your time, you may choose a car from a manufacturer with a great reputation for reliability, even though similar cars cost a bit less. Choices based on what you value are common in everyday life. But, unfortunately, when it comes to prescription medications, buyers may not have that option. And in the view of the U.S. Food and Drug Administration, this lack of transparency is contributing to ongoing drug shortages, a critical health care issue that reduces treatment options, limits access to medications, and can threaten the well-being of patients in need of important therapies. Let’s take a closer look.

All drug manufacturers that sell their medications in the United States must adhere to the FDA’s Current Good Manufacturing Practice (CGMP) requirements. Adherence to CGMP requirements is intended to make sure the drug itself is of adequate quality.

But there’s another element to quality in manufacturing — the ability to reliably make the product in sufficient quantities and with sufficient speed to ensure that supply consistently meets demand over sustained periods of time. This is especially true in the pharmaceutical industry, where the product is often life-sustaining — and ongoing access is critical.

Purchasers of prescription drugs such as drug distributors, hospitals, and pharmacies can be assured that FDA-approved medicines have been shown to be safe and effective for their labeled uses. Since these purchasers have tight budgets, they may select the lowest-priced product, in the absence of any other information. Also, they will often commit to purchasing many drugs covered within a single contract, placing pressure on each drug in that contract to be sold at the lowest price possible. So, several features of the modern market focus purchasers solely on price. But if purchasers also had the option to pay for reliable production, they might be willing to pay more for a medicine from a manufacturer with a proven track record of prompt and regular delivery of product, in order to avoid shortages.

Manufacturers with very high reliability usually have what is called a mature quality management system. However, purchasers currently are not able to readily identify those manufacturers. With today’s regulatory landscape, buyers actually have very limited information linking the medicine they buy with the facilities in which it was manufactured, other than the knowledge that the product was made under CGMP. More on drug shortages