In MedTech Dive, Beth Weinman Comments on Implications of FDA Consent Decree For Philips Respironics

In a MedTech Dive article, life sciences regulatory and compliance counsel Beth Weinman discusses how the U.S Food and Drug Administration (FDA) consent decrees generally work and what entering into a consent decree will likely mean for Philips Respironics, following an announcement by the company that it had reached an agreement with the U.S. Department of Justice about the terms of such a decree. The consent decree negotiations arose in the aftermath of a series of recalls involving the company’s sleep apnea devices and ventilators due to the breakdown of soundproofing foam used in the devices.

While the provisions of the consent decree are still being finalized, Beth notes in the article that consent decrees often require a “massive investment in remediation” and can be “quite painful” though, for some companies, a consent decree can be a “blessing in disguise.”

Beth adds that consent decrees often lay out a “clear roadmap for what needs to be done to come into compliance” and force a company to assign resources to the job. Beth acknowledges, however, that consent decrees provide the FDA with “a lot of power,” including the ability to require a company to shut down, stop doing a certain action, or recall a product without needing to go back to the court to get an order.