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July 15th, 2010

McNeil Consumer Healthcare Statement on its Manufacturing Operations

Posted by: Marc
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McNeil Consumer Healthcare is today announcing two actions related to its ongoing efforts to upgrade the quality of its manufacturing operations, and I wanted to share with you their statement:

McNeil Statement on Plan Submission

Today McNeil Consumer Healthcare has submitted to the FDA a comprehensive action plan on quality improvement. The submission details the next steps to be taken by McNeil to ensure that its operations meet the level of quality that consumers expect of us, and that we expect of ourselves.

McNeil looks forward to the FDA’s review of the plan and to working with the Agency moving forward. McNeil already has taken a number of significant steps to enhance quality, and is taking a systemic approach to strengthening quality through longer term improvements.

The plan addresses a number of areas, including:

  • Assessment and improvement of management controls;
  • Improvements in quality processes;
  • Interim controls and the use of outside experts to provide additional product quality assurance while the plan is being finalized and implemented;
  • Significant investment in manufacturing facilities, equipment, and laboratories, and;
  • A comprehensive program to ensure sustainable compliance with regulatory and McNeil quality requirements.

McNeil is committed to taking whatever steps are necessary to improve quality and earn consumers’ trust.

Statement on Fort Washington Plant

Consistent with its commitment to improve quality across its manufacturing operations, McNeil Consumer Healthcare will make a significant investment in re-fitting its Fort Washington manufacturing facility with new equipment, and will reorganize the plant’s operations. As a result, McNeil anticipates that the plant will be out of service for a protracted period of time. Regrettably, McNeil will be reducing staffing levels at the facility.

About 300 of the over 400 positions at the Fort Washington manufacturing plant are being eliminated as a result of this difficult decision. Employees whose positions are eliminated will be offered transitional support for the next year, including outplacement assistance, career counseling and professional support services to help them find a new position. McNeil has continued to provide employees with regular pay and benefits since operations at the plant were suspended in April, and will continue to do so through at least mid-September, at which point they will receive a severance package based on years of service.

When the plant reopens, McNeil anticipates some new hiring, and will provide preferential consideration to previous employees who are qualified for the new positions. However, staffing levels at the reconfigured plant are expected to be substantially lower than they are today.

McNeil is taking steps to expedite production of many of the products that were previously produced at Fort Washington by utilizing other plants in the Johnson & Johnson manufacturing network. As previously announced, although most products are not likely to be available before the end of 2010, McNeil expects to continue to expand its capacity to produce these products through the end of the year and in 2011.

June 25th, 2010

Richard B. Sellars

Posted by: Marc

Earlier today, we learned that Richard B. Sellars, who was Chairman and Chief Executive Officer between 1973 and 1976, passed away this week at age 94. My colleague, Margaret Gurowowitz, uploaded an extensive post on Mr. Sellars over on her blog, Kilmer House, that I thought I would share in its entirity here. From Margaret:


Kilmer House salutes Richard B. Sellars, retired Johnson & Johnson Chairman and Chief Executive Officer (he served from 1973-1976), who passed away this week at age 94. Though only chairman for three years, Mr. Sellars had a 40-year career with the Johnson & Johnson Family of Companies, and he had an impact that continues to be felt today. Two of the things we owe to him are successfully steering Johnson & Johnson through the tough economic times of the early 1970s, and committing the Company to stay in New Brunswick, New Jersey, where it was founded in 1886.

Richard Sellars joined Johnson & Johnson 71 years ago, at the tail end of the Great Depression in 1939, as a junior salesman for the newly formed Ortho Pharmaceutical Division and 40 years later, he was Chairman and Chief Executive Officer of the Company. From 1941 to 1945, Sellars was president and general manager of the Canadian Ortho affiliate company, after which he helped establish the manufacturing and sales divisions for Ortho in England and Scandinavia. In 1949 he joined Ethicon, Inc., which had just been formed out of the Company’s historic suture business that dated back to 1887; remarkably, he was chairman of the boards of both of those operating companies at the same time. In 1950, he was elected to the Johnson & Johnson Board of Directors (General Johnson was Chairman), and he became a member of the Executive Committee in 1957. In 1970 he was named president of Johnson & Johnson International, the organization that oversaw the Company’s international affiliates at that time.

Mr. Sellars was a member of management when General Robert Wood Johnson wrote Our Credo in 1943, and he was a strong believer in Johnson’s ideas about the social responsibilities of business as outlined in that document, especially as they related to the Company’s responsibilities to the community.

When Philip Hofmann became Chairman in 1963 – succeeding General Robert Wood Johnson – Mr. Sellars was named President and Chairman of the Executive Committee. When Philip Hofmann retired in 1973, Richard Sellars succeeded him as Chairman.

In the decades following World War II, New Brunswick – the Company’s home since 1886 – had suffered a visible economic decline. Discussions had begun among members of the Company’s management about relocating the Johnson & Johnson corporate headquarters outside of the city. Mr. Sellars, citing the third paragraph of Our Credo, which talks about responsibility to the community, guided our board of directors to make the decision to remain in New Brunswick, build a brand new world headquarters building here, and help revitalize the city.

Here’s what Richard Sellars said about that decision, as quoted in Robert Wood Johnson: The Gentleman Rebel:

“‘I looked at the Credo’s commitment to the communities where we work and live…and I reminded myself of General Johnson’s deep sense of loyalty to New Brunswick, his birthplace. Those two factors influenced the decision to remain in New Brunswick, but I also knew that we would have to work to revitalize the city to make it worth staying here.’” [Robert Wood Johnson: The Gentleman Rebel, by Lawrence G. Foster, Lillian Press, 1999, p. 614]

Among his other activities after he retired, Mr. Sellars led the revitalization effort for ten years, putting together local business, university, hospital and civic leaders to form New Brunswick Tomorrow, the organization that led and continues to be a leader in the revitalization. This partnership between all of the various public and private groups in New Brunswick initiated by Richard Sellars came to be held up as a national model for successful revitalization in other cities. The centerpiece of the effort was a new world headquarters for Johnson & Johnson designed by the internationally renowned architectural firm of I. M. Pei.

Because of Mr. Sellars’ foresight, Johnson & Johnson employees in New Brunswick can still literally walk in the footsteps of their colleagues from 1886, and Johnson & Johnson remains an integral part of the city in which it was founded by three brothers over a century ago.

June 3rd, 2010

Tweets About Today’s Analyst Meeting on the MD&D Segment


Earlier today, senior leaders from our Medical Devices & Diagnostics segment (which, BTW, is the the company’s largest business segment) held a meeting with the investment community to highlight the new products, pipelines, geographic presence and other strategies that will sustain the long-term growth of this business. You can listen to a replay of the webcast on our website, but below are a few of the tweets I put out earlier today:

J&J holds analyst meeting highlighting growth strategies for its Medical Devices and Diagnostics (MD&D) segment http://bit.ly/cdY11k

Webcast of presentations for J&J MD&D analyst meeting on J&J website http://bit.ly/gNVaT

MD&D day will highlight new products, including blood glucose monitoring/hernia repair systems, disposable contacts http://bit.ly/agrGrp

Gorsky, WW Chair, MD&D segment: can grow in underpenetrated mrkts thru intro of more advanced products/organic growth http://bit.ly/agrGrp

MD&D received more than 12 reg approvals so far in ’10, plans to make about 80 significant submissions between ’10-’12 http://bit.ly/agrGrp

MD&D segment continues to globalize current portfolios by developing more localized products for different markets http://bit.ly/agrGrp

May 27th, 2010

Colleen A. Goggins on the Recent McNeil Consumer Healthcare Recall

Posted by: Marc
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Today Colleen Goggins, Worldwide Chairman, Consumer Group, Johnson & Johnson, is appearing before the U.S. House of Representatives Committee on Oversight and Government Reform to discuss the recent McNeil recall of certain infants’ and children’s products. Here are some excerpts from her testimony:

All of the Johnson & Johnson family of companies realize that we have a responsibility to provide consumers with the highest quality products possible, and we have worked hard to fulfill that responsibility for more than a century. We are proud that our products help millions of people around the world improve their health and well-being. Across our organization, we believe our first responsibility is to the doctors, nurses, and patients, to mothers and fathers, and all others who use our products and services. In this instance, we have not lived up to that responsibility, and the recall is therefore a disappointment to our Chairman Bill Weldon, to me personally, and to the thousands of employees in the Johnson & Johnson family of companies.

The quality and process issues that we found at McNeil, those which led to the recall and others, are unacceptable. On behalf of McNeil and Johnson & Johnson, I apologize to the mothers, fathers, and caregivers for the concern and inconvenience caused by the recall. Johnson & Johnson embraces the work of this Committee, and we hope that today’s hearing will be an important step in furthering public understanding of the recall.

Consistent with our goal of furthering public understanding, it is critical that the public understand that the recall was not undertaken on the basis of adverse medical events. Unfortunately, there has been some confusion in the media with respect to this recall. I would like to stress, therefore, four key points. First, as the FDA noted last month, the health risks to consumers from the recalled products were remote. Second, McNeil has no indication of a serious adverse medical event caused by any of the issues referenced in the recall announcement. Third, no raw materials that tested positive for objectionable bacteria were ever used in the manufacture of McNeil’s pediatric products. And finally, McNeil rejected the products that it found had excess active ingredient.

For further details, click here to read the full testimony.

May 25th, 2010

McNeil Consumer Healthcare’s Plans to Assess and Address Quality Issues

Posted by: Marc
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To help inform employees of the Johnson & Johnson family of companies, McNeil Consumer Healthcare today released a description of its plans to assess and address quality issues which precipitated the recent recall of certain McNeil infants’ and children’s liquid medicines and the suspension of production at the Fort Washington PA manufacturing facility on April 30. Last Friday, McNeil submitted materials to the U. S. Food & Drug Administration which outlined its actions and plans to help ensure quality moving forward, and address the FDA’s observations at the plant. And this Thursday, Colleen Goggins, Worldwide Chairman, Consumer Group will represent Johnson & Johnson before the U. S. House of Representatives Oversight and Government Reform Committee, which has called a hearing on the recall. The following is the description of McNeil’s plans:

McNeil is taking steps to bring its operation back to a level of quality that Johnson & Johnson demands of its companies, and that the public rightly expects of us, and that we expect of ourselves.

First, even before the most recent recall was announced, McNeil retained an independent third-party expert to assist the Fort Washington facility in identifying immediate, interim, and long-term corrective actions that it needs to take. The third-party expert is a pharmaceutical consulting firm that has expertise in manufacturing and quality systems methodologies and practices.

Second, McNeil is improving processes and employee training in every part of the manufacturing and quality operations, and deploying new procedures and processes for the conduct of quality investigations.

Third, McNeil has also made significant organizational changes in order to augment the quality and operations leadership on the management team and in all McNeil facilities.

McNeil and its outside consultant are in the process of developing a comprehensive action plan on quality improvements, which McNeil will share with the FDA by July 15. The basic elements of the plan include the following:

Governance and management controls. Governance during the remediation period will include the establishment of a steering committee, which will include members of senior management, charged with guiding and overseeing remediation efforts across McNeil. Each plant will also have a remediation committee that will be responsible for implementing the plan for that plant and monitoring its effectiveness. Achieving long-term improved management control at each site is critical, and will require an evaluation and restructuring where needed of, among other things, the quality control unit, McNeil’s development and manufacturing governance processes, and its quality management systems.

Training and Culture of Compliance. McNeil is committed to reinforcing and enhancing the culture of compliance throughout the company. McNeil has already taken actions to set higher expectations of employees and to increase employee focus on identifying underlying causes and finding lasting solutions to issues that arise during daily operations. Further actions to address the culture of compliance under the comprehensive action plan will include strengthened “good manufacturing practices” training program, the development of a leadership training program and enhanced supervisor training, and the establishment of quality goals for all employees. McNeil also intends to implement measures to improve communications to and among personnel. Employees will be informed of the status of remediation and ongoing efforts on a regular basis through communications that enlist them in facilitating this transformation.

Full Assessment and Improvements. McNeil will conduct a full assessment of the processes, equipment, and facility in Fort Washington, and will assess McNeil’s other facilities as part of the plan. McNeil and Johnson & Johnson are fully committed to providing the training, resources and capital investment needed to provide sustainable improvement of quality systems.

Product Assessments. McNeil will conduct in-depth quality assessments for each product McNeil manufactures to ensure each product’s ability to meet specifications throughout its shelf life. Product assessments will review, among other things, testing results, stability data, investigation reports, out of specification findings, rejections, and process changes. McNeil will analyze whether additional controls are needed to support the release of products.

Communication with FDA and Interim Actions. McNeil will update the FDA about its progress implementing the plan at least once a month. McNeil also intends to use the support of a third party in making product release decisions during the first six months of operation. Third-party involvement may include review of investigations, complaints, completed batch records, and changes that have the potential to affect products or processes. McNeil is committed to continuing its cooperative and transparent dialogue with FDA.

These steps come on top of a series of important actions already taken, including an ongoing suspension of manufacturing operations at the Fort Washington manufacturing plant where the recalled products were made, and conducting extensive outreach to parents, caregivers and health care professionals to keep them informed about the recent recall.

May 19th, 2010

Update on the U.S. House Committee Hearing on the McNeil Consumer Healthcare Recall

Posted by: Marc
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Last week, Johnson & Johnson was advised that the U.S. House Committee on Oversight and Government Reform was planning to hold a hearing on May 27th on the recent McNeil Consumer Healthcare recall, at which Chairman and Chief Executive Officer Bill Weldon was invited to provide testimony. There have been some questions from the media about the company’s plans for the hearing, and I thought I’d pass on the statement we’ve been sharing with reporters:

We are working very closely with the Committee and the FDA on these important issues related to the recent recall of certain McNeil over-the-counter medicines. We look forward to addressing the Committee’s questions and concerns. As the FDA has stated, the risk of a serious medical event is remote. The recall was not undertaken on the basis of adverse medical events. McNeil and Johnson & Johnson remain committed to placing consumer safety first and have committed to a number of already-announced actions to begin remediation.

Prior to receiving the Committee’s invitation, Mr. Weldon was scheduled for back surgery today, from which he is currently recovering. Johnson & Johnson promptly informed the Committee upon receiving its request that Mr. Weldon would not be able to testify while he recovers from surgery. Consistent with his prior, open public statements about the recall, Mr. Weldon reiterated his willingness to communicate with the Committee after he recovers from surgery. Johnson & Johnson’s Worldwide Chairman of the Consumer Group, Colleen Goggins, is prepared to testify at the May 27 hearing.

May 14th, 2010

Battling the Obesity Epidemic in the Workplace


The following is from my friend and colleague, From Efrem Dlugacz who is Vice President Global Total Rewards & Health Resource.

Having worked for many years handling benefits for Johnson & Johnson, I can tell you that employee wellness and disease prevention is as important as to me as ensuring employees have access to different treatment options. For many years, we’ve been encouraging employees to develop healthy lifestyles, and one of the most pressing challenges we face is figuring out a way to address the impact that inactivity and obesity have on our workforce.

In that, of course, we aren’t alone. Did you know that about two-thirds of adults are overweight or obese in the US and the direct and indirect cost of obesity-associated conditions in the United States is estimated at nearly $80 billion a year? People who are overweight or obese are at a greater risk for developing diabetes, stroke, hypertension, high cholesterol and certain types of cancers – and for an employer, that can mean greater absenteeism and higher healthcare costs compared to non-obese employees.

But employers can help make a difference.

We’ve found that employees who are inactive, overweight or obese, benefit greatly from company sponsored programs that focus on healthy living, eating, and exercise. In 1978, Johnson & Johnson launched “Live for Life,” a program tailored to address individual employee health needs. Since then, we’ve developed, launched and measured a number of successful wellness and prevention programs and as a result, our employees are motivated and encouraged to improve their health and reduce related health care issues. As National Employee Health & Fitness Day approaches, we invite you to check out the following video about one Johnson & Johnson employee – Jessica Empestan – who benefited from these programs:


H

elping employees manage their weight and healthier lifestyles are important for all businesses – not just because it is the right thing to do, but because it makes good business sense. Studies show that by combating obesity in the workplace we can decrease employee absenteeism, improve productivity and reduce health care costs. All these important benefits strengthen businesses in the long term. We believe society will not succeed in reducing health care costs and improving lives … until we pay as much attention to preventing disease and its complications as we do to treating it, or insuring care.

May 10th, 2010

Twittering Along…

Posted by: Marc
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For more than a year now, I’ve been Tweeting on behalf of Johnson & Johnson over at @JNJComm and have found it to be a great way to meet and interact with new people, keep up with the latest news and be available when people have different questions about what we are doing as an organization.

Well, now I’m pleased to welcome a few of my colleagues to the Twittersphere. Over the last few days, my colleagues including Rob Halper, who is responsible for the Johnson & Johnson YouTube Channel, Margaret Gurowitz who writes the Kilmer House blog, Mark Krajnak, who is responsible for the corporate website (and a photographer extraordinaire) and fellow JNJBTW contributor Melissa Waggenspack, have set up their own Twitter accounts and are starting to Tweet.

Those accounts include:

@JNJStories – where Mark and Melissa will share stories about our company, our people, our partners, our patients and our customers.

@JNJvideo – where Rob Halper will be posting a variety of tweets that touch on his world of video content.

@JNJHistory – where Margaret will post about different historical facts, figure and stories

I, of course, will continue to Tweeting about different Johnson & Johnson-related news and events, announcements, interesting posts and content that’s been uploaded to our sites and other musings on stuff I find cool and interesting. I’ll also continue to be on hand on Twitter to respond to any questions you may have.

Tweet, Tweet.

May 7th, 2010

To All Who Use Our Products — From Bill Weldon

Posted by: Marc
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I just wanted to share the following open letter from Chairman and Chief Executive Officer Bill Weldon about the recent recalls at our McNeil Consumer Healthcare company. He asked us to publish it by posting on JNJBTW:

To All Who Use Our Products,

We have a responsibility at Johnson & Johnson to provide you with the highest-quality products possible, and we have worked hard to fulfill that responsibility day-by-day for over a century.

The recent recalls of some over-the-counter medicines from our McNeil Consumer Healthcare operating company are a matter of great concern. They are a disappointment to me, and to the employees of the Johnson & Johnson Family of Companies. You can be confident that we will make whatever changes are needed at McNeil to fully restore the quality of its manufacturing.

As reported, McNeil has suspended all manufacturing operations at its facility in Fort Washington, Pa., until we can be sure that they are operating under the standards we demand of ourselves, and which our customers expect of us. McNeil has also retained independent quality experts to assist in this regard and is re-evaluating quality systems and manufacturing processes across the organization.

I have been assured that the chance of a serious medical event from the recalled products is remote. Even so, this does not give us comfort; one of our companies has let you down.

For now, please check your infants’ or children’s forms of TYLENOL®, MOTRIN®, ZYRTEC® or BENADRYL® and discard any medicines that are being recalled. You can check the list of recalled lots, apply for refunds, and get more information about the recall at McNeil’s dedicated website (http://mcneilproductrecall.com), or by calling 888-222-6036.

We will work hard to earn back your confidence.

Sincerely,

Bill Weldon

May 4th, 2010

McNeil’s Response to Today’s News

Posted by: Marc
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Earlier today, the U.S. Food and Drug Administration issued a report describing manufacturing-related observations from inspections of the McNeil Consumer Healthcare facility at Fort Washington, PA related to the recent recall announcement and later held a press conference to go over their findings. In response, McNeil issued a public statement. You can read the entire statement, but I thought the following passage is important to note:

We have no higher concern than providing parents with the highest quality products for their children. The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate. While the chance of serious adverse medical reaction is remote, we apologize to those who rely on our medicines for the concern and inconvenience this recall may have caused. We will provide a detailed response to the FDA on their observations, and work diligently to ensure that they are addressed.

A complete list of the products involved and additional information about the recall can be found on their website, www.mcneilproductrecall.com or by calling 1-888 222-6036.