Pharmaceutical manufacturers might be interested to know that Food and Drug Administration inquiries have led to fewer enforcement actions. The agency Office of Prescription Drug Promotion issued just nine warning and untitled letters during 2015, an all-time low, according to the Eye on FDA blog. In the context of recent years, the 2015 figures suggest a trend. In 2014, the FDA issued 11 warning letter. Those totals are down from a high of 52 warning letters issued by the FDA in 2010.  So what’s going on? As consultants with experience responding to FDA form 483 inspections and warning letters, PharmEng Technology can offer drug companies regulatory insights.

The FDA’s enforcement actions are best observed through a wider lens. Between 1997 and 1999, the FDA’s Office of Prescription Drug Promotion issued more than 100 warning letters, reaching a peak in 1998, when the agency issued 156 letters, notes STAT. That was the year that followed the FDA’s allowance of expanded direct-to-consumer drug advertising. The decline in FDA warnings might not necessarily be a reduction in the number of infractions, STAT says. Instead, it could be that the FDA has been slow to issue regulatory guidelines that whose scope encompasses violations that would trigger warning letters.

In a statement to STAT, the FDA says that looking at a snapshot of time for enforcement letters does not provide a complete picture of the agency’s enforcement actions. But Eye on FDA notes that in the past few years, FDA enforcement has targeted companies that are “lesser known and are likely to have fewer products on the market.” That’s not to suggest that large drug makers are better at complying with FDA regulations. It could be indicative of where the FDA’s focus is, though Eye on FDA notes that the regulator is not likely offer more information about where it targets enforcement actions.

Pharmaceutical companies have too much at stake to try to guess what the FDA is looking for as it carries out its enforcement strategy. PharmEng’s experience can help guide drug makers as they draw up their compliance plans. To learn more, contact us.