March 10th, 2011

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.

7 Responses to “McNeil-PPC Finalizes Terms of a Consent Decree with the US FDA: Perspective from J&J Chairman and CEO Bill Weldon”

  1. Pharm Aid says

    Thank you for posting this highly-sanitized note from your lawyers. Legal-speak to avoid further class action lawsuits is not the same thing as real, meaningful communication with your stakeholder audience. You can take a lesson from your colleague Caroline Pavis on what a real, genuine communication might look like.

    Although, given the lack of coverage on over the past few months to the mounting manufacturing crisis at the J&J family of companies, I was extremely surprised to see you stepping up and posting this note at all. It’s better than nothing…but it’s still not a meaningful.

    It’s not too late – you can return the Credo and the principles that made you a once-great company. But the public is running out of patience…

  2. Howard says

    After over thirty years in the Quality Assurance Division, I never would have thought I would see this day.
    What first comes to mind is the unmasking of the wizard of Oz.
    I can remember attending meetings about the quality of the print on a corrugated shipper as that logo represented the company and the corporation. It had to be pristine as the “general’ would have expected and as was guided by the Credo.

    This is a shame.

  3. Howard says

    I’d like to add to my prior comment.

    Here is a statement which we sincerely believed in and was posted on the bottom of many of our e-mails and in many offices.

    Quality is never an accident; it is always the result of sincere effort,
    High intention, intelligent direction and skillful execution.
    It is the wise choise of many alternatives.

    (source unknown)

  4. Kenneth McCullough says

    My early experience with J&J and Ethicon, Inc. was when Philip B. Hoffmann was CEO. During that time, Mr. Hoffmann held a world-wide Credo tour, where all employees were told the history and significance in Our Credo (well before the initial Tylenol crisis). As part of those Credo discussions, we were given a book entitled “General Johnson Said”, a book of quotes by The General, as all very respectfully referred to him at the time. One of his quotes stuck with me, and is also believed and practiced by my own kids today. To quote: “Management is cause…. All else is effect.”

    I believe that has always held true within the J&J Family of Companies, and McNeil PPC, and all up the line from there, must face that fact.

    Thank you for providing a forum within the Company where thoughts such as these can be presented.
    Kenneth McCullough
    Ethicon, Inc. (Ret.)

  5. Jackie says

    II think the actions Chairman Weldon describes fall far short of taking responsibiliuty. What I want to know is why the person most responsible for this fiasco, Colleen Goggins still has a job. Until Mr. Weldon deals with the person responsible, he really hasn’t taken responsibiliuty. As a retiree I am so embarrassed by the actions of a company I used to be proud to belong to.

  6. smartin says

    Where do I find an update on the $70,000,000 fine paid by J&J to the federal government for overseas bribery?

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