The Post Post-market Period

You knew it was coming. The moment that Vioxx became a common word among trial lawyers, the FDA was forced to sit up and take notice. As the industry braces for the agency’s greater enforcement of post-market surveillance efforts, can we expect more fines and sanctions against companies that have been lax in their vigilance programs?

Enforcement of post-market surveillance has been lax in the past, and the FDA and the Centers for Medicare and Medicaid Services (CMS) will certainly address this in the near future. With a rash of high-profile drug and medical device recalls recently, and Congress demanding answers from the FDA, it’s a sure bet that these agencies will insist on better post-market data from manufacturers.

As reported in this month’s Regulatory Perspective column, the agencies may collaborate on a common database containing post-market data. This should help the FDA better track adverse events, but the effectiveness of such a proposal will depend on execution. As it stands, event reporting is inconsistently practiced throughout the healthcare system. Data generated is often incomplete or under-reported. This makes the FDA’s job to protect patients difficult.

If CMS and the FDA get on the same page, product safety may be improved because companies that want reimbursement will have to do a better job of tracking post-market data, which can then be shared with the FDA. Assuming the agency puts the data to good use, problem devices will be uncovered more quickly, which means fewer patients will be at risk.

But better post-market surveillance isn’t just good for patients; it’s also protection for the device OEM. Sure, implementing an effective program can be costly and time consuming, but it’s better than agency enforcement action and the inevitable spate of lawsuits that follows. In Rene van de Zande’s Euro News column, he explains how companies that incorporate surveillance in their risk management plans are better off. You might reconsider your post-market surveillance program after reading this issue.

As an editor, I loathe self-promotion, but I’d like to make an exception and urge industry professionals closely involved in outsourcing to attend the MPO Summit September 18-20 in Princeton, NJ. This inaugural event is the only one that specifically addresses outsourcing in the medical device industry. A number of knowledgeable speakers—both OEMs and contract manufacturers—will address cutting-edge trends.

As always, I encourage our readers to contact us with their thoughts. After all, your ideas and feedback can only help MPO deliver more of the content important to you and your colleagues.