Content By Michael Kopcha

By: Michael Kopcha

The U.S. Food and Drug Administration (FDA) is working with drugmakers in a new way to help the industry adopt scientifically sound, novel technologies to produce quality medicines that are consistently safe and effective—with an eye toward avoiding drug shortages.

When manufacturing problems arise in drug manufacturing facilities, drug shortages may follow. In fact, 65 percent of all drug shortages are caused by manufacturing and quality issues. This underscores the need for a safe and reliable drug supply chain.

In recent years, hundreds of drug shortages have been reported to the FDA. The agency has done much to minimize their impact and prevent future shortages. For example, it expedited the review of new applications for generic drugs when potential shortage issues arise with approved drugs.

Unfortunately, a significant number of these shortages have affected patients with serious conditions, including cancer, life-threatening infections, and severe malnutrition. These shortages can delay or prevent care to patients and can leave practitioners with no other option but to prescribe less effective therapies.