The FDA has given Philips the green light for its Emergency Care and Resuscitation business to resume development and distribution of defibrillators in the U.S., following a two-and-a-half-year injunction.
The injunction was issued through a consent decree
in November 2017 after the FDA accused the company of violating current good manufacturing requirements mandated by the Federal Food, Drug and Cosmetic Act (FD&C Act) and of being noncompliant with quality system regulations in its manufacturing of AEDs and Q-CPR Meters. The government also accused it of not setting up adequate processes to fix the issues.
"The injunction lift is an important milestone for Philips, as we have enhanced the regulatory compliance processes in our ECR business and throughout the company," said Frans van Houten, CEO of Royal Philips, in a statement. "Providing our customers with safe and reliable products and solutions remains our highest priority, and I am proud that our AEDs save lives daily, with their very high reliability record."
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The injunction required the Dutch healthcare giant to stop manufacturing its defibrillators at its U.S. facilities in Andover, Massachusetts and Bothell, Washington until the FDA could inspect and certify that the sites complied with Quality System Regulations. Specific Philips automated external defibrillator models were exempted to ensure U.S. providers could access the lifesaving device. The company was also allowed to still provide necessary device servicing, accessories and consumables.
Philips subsequently restructured its quality control function and appointed new leadership, retrained personnel and introduced culture change initiatives to become compliant with the necessary regulations.
The lifting of the injunction comes as the company and the rest of the world grapple with the ongoing COVID-19 virus, which contributed to a 2% decrease in comparable sales
for its first quarterly earnings of 2020.
"The start of 2020 was marked by the COVID-19 outbreak, and we have mobilized our resources since January to address this unprecedented challenge,” said van Houten. “At Philips, we are focused on our triple duty of care: meeting critical customer needs, safeguarding the health and safety of our employees, and ensuring business continuity. I am very proud of the commitment, hard work and resourcefulness of our employees to keep Philips fully functioning, and I would like to thank them for that.”
The consent decree is still in effect and includes continuing regulatory compliance monitoring and FDA facility inspections of Philips’ ECR business, as well as its other patient care businesses.