[SOLVED] Johnson & Johnson (J & J) enjoyed a halo

Johnson & Johnson (J & J) enjoyed a halo effect for many decades after their iconic precautionary recall of Tylenol capsules in 1982, which was greatly facilitated by the famous Johnson & Johnson Credo1 that stipulated patient well-being to be para- mount in importance. But that halo has now been lost due to the events that led to the company’s recall of children’s Tylenol and other children’s medicines in 2009 and 2010.
On April 30, 2010, J & J’s McNeil Consumer Healthcare, LLC (McNeil Division), “recalled some 50 children’s versions of non-prescription drugs, including Tylenol, Motrin, and Benadryl.”2 In total, 136 mil- lion bottles of liquid were involved.3 This was the fourth recall in seven months. Earlier recalls included the following:
• November 2009—five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap due to reports of an unusual moldy, musty, or mildew-like odor that led to some cases of nausea, stomach pain, vomiting, and diarrhea.
• December 2009—November recall expanded to all lots of the product.
• January 2010—an undisclosed number of containers of Tylenol, Motrin, and over-the-counter drugs after consumers complained of feeling sick from an unusual odor.4
The McNeil Division had four plants, including those at Fort Washington, Pennsylvania (operated as a joint venture with Merck & Co.), and Las Piedras, Puerto Rico. J & J shut down the Fort Washington plant in April 2010 just before an unannounced inspection from the U.S. Food and Drug Administration (FDA). But according to the FDA Statement to the Committee of Oversight and Government Reform of the U.S. House of Representatives on May 21, 2010,5 FDA concerns over the company’s manufacturing processes began several years earlier.
The FDA is responsible for ensuring that companies manufacture and distribute drugs that are safe for consumers in accordance with current Good Manufacturing Processes (cGMP) that cover minimum requirements for methods, facilities, and controls used in the manufacturing and packaging of the products. According to the FDA Report, Under the cGMP regulations, each manufacturer sets specifications for its own products for such factors as potency, stability and purity, and puts in place a quality system that ensures those specifications are met. Critical to the cGMP process is that a company must meet its own standards.
A violation of cGMP does not necessarily mean that a product is hazardous to the public. It does indicate, however, a breakdown in a manufacturer’s quality system and is an indication that a company needs to take effective steps to fix the problem promptly.
FDA inspects facilities to ensure compliance with cGMP standards. These inspections occur on aver- age for domestic facilities every two to three years. We increase the frequency of inspections for facilities when warranted by past problems or by products that are difficult to manufacture or are especially high risk.6
Prior to 2009, the statement says, the FDA inspections had noted several problems with “laboratory controls, equipment cleaning processes, and a failure to investigate identified problems,” but these were “generally fixed.” During 2009, the FDA identified several more problems, including the following:
• At the Fort Washington plant—failure of McNeil to meet its own standards for an ingredient, microcrystalline cellulose, that required it to use input with no Gram-negative bacteria. The supplier found that some partial lots of a master batch did contain a Gram- negative bacteria known as B. cepacia, and although the lots McNeil used did not test positive, none of the partial lots from this batch should have been used. Although the FDA concluded the risk to the public was remote, 8 million bottles of finished product were recalled in August.
• At the Las Piedras, Puerto Rico plant— FDA urging resulted in McNeil investigating year-old complaints about products from the plant having a musty odor and finding that it was attributable to a pesticide (2, 4, 6-tribromoanisole [TBA]) used on wooden storage pallets for empty medication bottles. Again the risk to the public was thought not to be serious for long-term health problems because of the small quantities transferred, although exposure could include nausea, stomach pain, vomiting, and diarrhea. In this case, McNeil should have reported the problem to the FDA within three days of the first reports. The FDA also reported that little is really known about the chemical TBA.
These incidents led the FDA to send a warning letter on January 15, 2010, to McNeil, but upper management at neither McNeil nor J & J responded to ensure timely investigation and resolution of the issues raised. At about the same time, the FDA investigated a report of the death of a six-year-old girl but could not relate her death to any of the company’s medications. On February 19, 2010, the FDA called senior officials from McNeill and its parent company J & J to a meeting to give them notice about the patterns of violation of cGMP standards, recent recalls and warning letters, and failure to report information to the FDA in a timely manner. At the meeting, the FDA was told that structural changes, new management, and a new consultant were to be put in place to deal with these problems.
The FDA investigators returned to the Fort Washington plant in April 2010 to find that just days before, it had been shut down because particulates, including acetaminophen, cellulose, nickel, and chromium, had been found in several liquid medications. Moreover, bacteria and particulate counts exceeded the company’s cGMP standards, and Tylenol in too high a strength had been manufactured but not sold. Although the particulates were small enough to pass out through the intestinal tract without harm, there was justifiable concern over the lack of appropriate safety-conscious culture and safeguards in place.
The FDA report concluded by indicating that they did not think the public had been subject to any serious health risk, but they were concerned and would be working with management to rectify this issue raised. They were also considering such enforcement actions as seizure, injunction, or criminal penalties. In addition, the FDA stated that they had learned several lessons that would factor into a revision of FDA inspection procedures, linkage of findings at on company site to another such site, and recall procedures.
On July 21, 2010, the FDA released a report on its investigations at another of J & J’s plants—this one located in Lancaster,
Pennsylvania—that indicated a pattern of ignoring rules for manufacturing and quality, failure to investigate problems that could affect the composition of products, carelessness in cleaning and maintaining equipment, and shoddy record-keeping.7
The report listed 12 types of violations, including the following:
• “Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures to assure that drug products conform to appropriate standards of identity, strength, quality and purity.”
• Procedures to prevent “objectionable microorganisms” from getting into medicines appear not to have been followed.
• “Deviations from written test procedures are not justified.”
•Staff were not following up “to deter- mine the causes for repeated mix-up of tablets.”
• Written procedures for cleaning and maintenance did not have enough detail about the methods, equipment, and materials to be used.
• The plant did not have recent drug production and quality control records readily available to the inspectors, as is required.
• Samples of drug products taken to deter- mine if they met written specifications were not properly identified.
• There was no preventive maintenance program for at least five types of complex manufacturing or testing equipment.8
On the day the report was released, J & J’s stock dropped 2.5% to $57.12. Estimates of the cost of recalls and the shutdown of the Fort Washington plant were $600 mil- lion in 2010. The Fort Washington plant manager had been fired, and 300 to 400 workers had lost their jobs.9
Questions
1. Who was really to blame for the lax procedures found?
2. How should this situation be remedied?
3. How could the job done by the FDA be improved?
4. J & J had lived under a positive halo due to their earlier recall of tainted capsules of Tylenol. Why did J & J people behave differently almost thirty years later?
5. How would the total cost of this debacle be estimated?

Question: Johnson & Johnson (J & J) enjoyed a halo