In the US, FDA is tackling the issue with new guidance. A recently issued draft document, Notification to FDA of Issues That May Result in a Prescription Drug or Biological Product Shortage, is meant to address growing concerns by increasing communication between industry and regulators. The draft guidance clarifies that the "sole manufacturer" (i.e., the only applicant currently supplying the market with the drug product) holds responsibility for reporting such information. The document also calls out certain actions that may lead to a temporary or permanent drug supply problem, such as delays in acquiring active or inactive ingredients, equipment failures and manufacturing shutdowns. Manufacturers will need to notify FDA of these issues if they could lead to disruption in supply. The agency also asks industry to notify it on a voluntary basis when certain problems (e.g., stability concerns, facility transfer) could "reasonably" be expected to lead to a shortage or disruption.
I have high hopes for solving the global drug supply problem. In 2010, for example, 38 shortages were prevented in the US alone because companies notified FDA of potential problems. Meanwhile, in the UK, where parallel trade has led to certain drug shortages, the Medicines and Healthcare products Regulatory Agency has pledged to address shortages and is working to better track which products are in short supply and who is exporting them. As long as companies do their part, these regulatory efforts should pay off. Just as we tell our children, it's always best to tell the truth—even if it hurts a little to do so—because in the end, it's simply the right thing to do.Angie Drakulich is the editorial director of PharmTech Europe.