McNeil-PPC Finalizes Terms of a Consent Decree with the US FDA: Perspective from J&J Chairman and CEO Bill Weldon
Earlier today, McNeil-PPC, Inc., a subsidiary of Johnson & Johnson, announced that it finalized the terms of a Consent Decree of Permanent Injunction (Consent Decree) with the U.S. Food and Drug Administration (FDA) for manufacturing facilities operated by the McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. in Las Piedras, Puerto Rico, Fort Washington, Pennsylvania, and Lancaster, Pennsylvania. You can read the details of that announcement in the press release that was issued.
At the same time, Chairman and Chief Executive Officer Bill Weldon sent out an internal note to all Johnson & Johnson employees about the announcement. In it, he provided additional perspective about steps the company is taking:
I am writing to let you know that one of our companies, McNEIL-PPC, Inc., today will enter into what is known as a “Consent Decree” with the U.S. Food and Drug Administration (FDA). The Consent Decree is an agreement we have reached with the FDA to govern certain McNeil Consumer Healthcare manufacturing operations until McNeil completes the remediation of its facilities to the FDA’s satisfaction. The Consent Decree is subject to approval by the court.
There are other outstanding legal matters involving Johnson & Johnson companies that have been discussed in past public filings and covered in the media. We will keep you advised of critical developments in these matters just as we are now providing information about this Consent Decree and McNeil.
We are a company that strives to do the right thing, and we succeed far more often than not. When we don’t succeed, it’s painful. But, consistent with Our Credo, we take responsibility for our actions, and we learn from our mistakes. By moving to resolve the FDA’s concerns about McNeil Consumer Healthcare US manufacturing facilities, we are able to look to the future and focus on what is most important to us: serving the millions of people around the world who rely on our products every day to meet their health care needs.
The Consent Decree applies to manufacturing facilities in Fort Washington, Pennsylvania; Lancaster, Pennsylvania; and Las Piedras, Puerto Rico. Under the terms of the agreement, McNeil will continue to operate the facilities in Las Piedras and Lancaster, working with an independent expert who will develop a plan for improving operations and will conduct reviews of certain production records while remediation is ongoing. McNeil also has agreed that it will not re-open the Fort Washington manufacturing facility – which it voluntarily closed in April 2010 – until it is certified by an outside expert and approval is given by the FDA.
Under its Comprehensive Action Plan, McNeil has made important progress toward improving quality and compliance, such as accelerating changes in organization and culture, and conducting a thorough review of how the company operated its manufacturing plants. We believe the terms of the Consent Decree recognize this progress and are consistent with the work underway. At the same time, the Consent Decree requires additional quality assurance measures, and is a reminder that important work remains to be done. We will commit whatever time and resources are necessary for McNeil to address the issues raised by the Consent Decree.
While the particular issues involved in the Consent Decree are limited to McNeil, all of us across the Johnson & Johnson Family of Companies should take this opportunity to re-dedicate ourselves to working hard every day to do the right thing for patients and ensuring their trust.