Product News and Recalls

The FDA’s New Year Resolution

fda to take active role in device error pattern predictionAs New Year’s Day came and went, millions of people across the country considered their resolutions for 2016. Statistically, most probably resolved to lose a few pounds. Others thought about reading more, taking a class or two, becoming more patient, or bettering themselves in some other way.

It looks like the FDA might have made a resolution or two of their own. And, among them, the federal agency responsible for ensuring that Americans are only putting safe food and drugs in their bodies might have resolved to start doing their job more aggressively.

The US Food and Drug Administration gave the people plenty of cause for frustration in 2015. Among the most impactful was a draft guidance issued in early 2015. This guidance coupled with court rulings essentially gave drug manufacturers the ability to distribute information to doctors that openly rebuts the information they are forced to print on their labels.

The agency also came under fire last summer for its approval of the use of OxyContin in children as young as eleven years old. OxyContin is an incredibly powerful opioid. So, when a federal agency approved its use in children in a nation that is already facing an unprecedented epidemic of opioid abuse and overdose, many took notice. Among them was West Virginia Senator Joe Manchin who called for an investigation into the approval.

The revolving door at FDA would surely have been the subject of any such investigation. One needs only to search for a few seconds to discover the impact of this unspoken reality that permeates almost every hall of government. Pharmaceutical executives are tapped for leadership roles in federal regulatory agencies. This, in turn, leads to eventual leadership roles at lobbying firms. Conflicts of interest are created almost immediately as executives with high-value stakes in multi-billion dollar corporations are placed in roles which allow them to shape polices that regulate those very corporations.

Given all of this, it becomes very easy to appreciate the shock some felt when news broke in late December that the FDA will become more aggressive in its stance on medical device warnings.

2015 saw a huge number of medical device failure lawsuits. These included IVC filter failures, metal-on-metal hip replacement failures, and transvaginal mesh lawsuits, among others.

The agency noted that its existing systems for public communication may not be enough and that action should be taken on potential medical device issues far faster than in has been in the past. Rather than waiting until an obvious pattern of failures has come to light, the FDA now hopes to predict medical device failures earlier.

The draft guidance states that there “is a need to notify the public about emerging signals that the agency is monitoring or analyzing, even when the information has not been fully analyzed, validated, or confirmed, and for which the agency does not yet have specific recommendations.”

This, of course, has medical device manufacturers taking notice. And, the question remains of what will be left once the policy is inevitably watered down. The proposal comes with a requisite 60-day period in which device manufacturers and other industry executives are welcomed to provide their own input and concerns. One can only assume that these concerns will be aired both within the walls of the FDA and at countless expensive dinners in and around the nation’s capital.

Whether the emerging guidance will have any remaining teeth remains to be seen. If it does, however, 2016 could be a very interesting year for an industry pounded by failures, lawsuits, and untold harm to patients and their families.