PharmaGossip: Plastic: Johnson & Johnson's Recall Of Children's Medicines And The Phantom Recall, Part 2

Johnson & Johnson's Recall Of Children's Medicines And The Phantom Recall, Part 2
found on House.gov
written by mycena, edited by Humberto (Plastic) [ read unedited ]
posted 1 hour, 18 minutes ago

On April 30, pharmaceutical company Johnson and Johnson initiated the largest recall of children's medicine in history. More than 135 million bottles of children's medicine (Children's Tylenol, Children's Motrin, Children's Benadryl and Tylenol Infants' Drops) were recalled. Intrigued (warned by the FDA), Congress started an investigation.
During this investigation, the Committee on Oversight and Government Reform found that at least one other mass recall (of Motrin, but for adults) had happened in the years before, without any press reports or any form of warning to the general public, or even the FDA. A plant in Fort Washington, Pennsylvania, that appeared to be the cause of the Motrin problems had been shutdown by the J&J subsidiary that owned it: again without mentioning to the public, or the controlling agency.
Things didn't exactly improve for J&J after that first investigation.
For starters, the Committee obtained additional documents showing that high-placed J&J executives had been more than economical with the truth to the first investigation. Specifically, the executives under questioning had claimed they didn't know exactly how the third-party contractor (Inmar), hired to carry out the "phantom recall", was handling its task. Not true: J&J was dictating how the recall was to be carried out, and full-well aware of its reasons for doing so (avoiding PR damage). Secondly, new documents showed that the same company, Inmar, had also been hired for another recall, in Sept 2009, of Children's Tylenol.
So the Committee initiated a second investigation, to clear up "the apparent discrepancy between J&J's testimony in May and the documents that have come to light since".
In his testimony (pdf), the CEO of Johnson & Johnson, William C. Weldon, insisted that nothing serious had happened and all was a matter of solid precautionary practice.
"As an initial matter, it is important to keep in mind that the Motrin retrieval and subsequent recall were not prompted by safety concerns about the product. Rather, the caplets were found not to dissolve as quickly as intended." and "Importantly, the issue that prompted the discussion and eventual recall [of Tylenol] in September 2009 presented only a remote risk to patient safety. The September 2009 voluntary recall was undertaken out of an abundance of caution because objectionable bacteria had been found in raw material that was rejected and not used in production."
As a precautionary measure, the company shut down the Fort Washington plant involved, and issued a broad recall of all liquid medicines made at the plant, a subsequent revamp into a state-of-the-art medicine production plant, combined with an investment program of more than $100m on facilities, equipment, and other improvements across the rest of the J&J subsidiary that owns the factory. There was, however, no mentioning of specific actions undertaken at the Las Piedras, Puerto Rico, plant responsible for the Tylenol recall in Sept 2009 (which still has ongoing problems, apparently).
According to him, the J&J subsidiary (McNeil) appointed a new vice president of quality assurance, a new vice president of operations, a new plant manager for the Fort Washington location, and a new head of quality for the same plant immediately after the recall.
Then there was the testimony (pdf) of Ms Colleen A. Goggins, Worldwide Chairman, Consumer Group, Johnson and Johnson.
According to her, the FDA was informed of the [Tylenol] recall (which happened in September of that year), by an April 21, 2009, Field Alert to the FDA's San Juan office. She stated that she only was aware the Committee might be interested in the use of a third-party contractor for carrying out the [phantom/Motrin] recall, on the morning of her first testimony, and had never before seen the subcontractor documents shown to her during that first investigation either. She ended her (short) testimony with announcing her retirement from Johnson & Johnson, after nearly 30 years with the company.
Josua Sharfstein represented (pdf) the Food and Drug Administration in this hearing. He offered a brief update on the current ongoing FDA investigation related to the case — starting out by saying that the agency couldn't establish a direct link between the "several recalls" and any serious adverse events, including death.
Products coming from the Las Piedras facility had a musty, moldy odor, later identified to be coming from a pesticide (TBA, 2, 4, 6-Tribromoanisole) used to treat the wooden pallets. The FDA had issued a warning about the matter to McNeil on Jan 25, and was currently in the process of doing a follow-up inspection of the facility. Mr Sharfstein specifically mentioned "the breakdowns in leadership and oversight that led to these serious compliance problems", questioning whether "McNeil's corporate culture supported a robust quality system to ensure the purity, potency, and safety of its products."

There is currently a related criminal investigation going on about the matter, but what has become clear, and might be a bit surprising, is that the FDA has no legal power to force a company to do a recall: the J&J problems with Motrin were already known in November 2008, but the actual recall only started in August the following year.
What's more, a company doesn't even have the legal obligation to notify the FDA if it is doing such a recall. The FDA may pursue a seizure in federal court, but this can be a time-consuming and cumbersome procedure -- and the Agency should need to undertake hundreds of separate seizures in order to ensure all products in violation were taken off the market.
So, question: should we see the [the issues leading to the ] whole phantom recall, and the phantom recall itself, as a one-off error -- or is a "recall system that depends on full and open disclosure, trust, and the industry's acceptance of its responsibilities to protect the public from violative products" simply not enough anymore?
[ comment on this story | more plastic... ]

via plastic.com

Posted via email from Jack's posterous

PharmaGossip

Tuesday, October 26, 2010

Plastic: Johnson & Johnson's Recall Of Children's Medicines And The Phantom Recall, Part 2

No comments:


	Johnson & Johnson's Recall Of Children's Medicines And The Phantom Recall, Part 2


	found on House.gov written by mycena, edited by Humberto (Plastic) [ read unedited ] posted 1 hour, 18 minutes ago


		On April 30, pharmaceutical company Johnson and Johnson initiated the largest recall of children's medicine in history. More than 135 million bottles of children's medicine (Children's Tylenol, Children's Motrin, Children's Benadryl and Tylenol Infants' Drops) were recalled. Intrigued (warned by the FDA), Congress started an investigation. During this investigation, the Committee on Oversight and Government Reform found that at least one other mass recall (of Motrin, but for adults) had happened in the years before, without any press reports or any form of warning to the general public, or even the FDA. A plant in Fort Washington, Pennsylvania, that appeared to be the cause of the Motrin problems had been shutdown by the J&J subsidiary that owned it: again without mentioning to the public, or the controlling agency. Things didn't exactly improve for J&J after that first investigation. For starters, the Committee obtained additional documents showing that high-placed J&J executives had been more than economical with the truth to the first investigation. Specifically, the executives under questioning had claimed they didn't know exactly how the third-party contractor (Inmar), hired to carry out the "phantom recall", was handling its task. Not true: J&J was dictating how the recall was to be carried out, and full-well aware of its reasons for doing so (avoiding PR damage). Secondly, new documents showed that the same company, Inmar, had also been hired for another recall, in Sept 2009, of Children's Tylenol. So the Committee initiated a second investigation, to clear up "the apparent discrepancy between J&J's testimony in May and the documents that have come to light since". In his testimony (pdf), the CEO of Johnson & Johnson, William C. Weldon, insisted that nothing serious had happened and all was a matter of solid precautionary practice. "As an initial matter, it is important to keep in mind that the Motrin retrieval and subsequent recall were not prompted by safety concerns about the product. Rather, the caplets were found not to dissolve as quickly as intended." and "Importantly, the issue that prompted the discussion and eventual recall [of Tylenol] in September 2009 presented only a remote risk to patient safety. The September 2009 voluntary recall was undertaken out of an abundance of caution because objectionable bacteria had been found in raw material that was rejected and not used in production." As a precautionary measure, the company shut down the Fort Washington plant involved, and issued a broad recall of all liquid medicines made at the plant, a subsequent revamp into a state-of-the-art medicine production plant, combined with an investment program of more than $100m on facilities, equipment, and other improvements across the rest of the J&J subsidiary that owns the factory. There was, however, no mentioning of specific actions undertaken at the Las Piedras, Puerto Rico, plant responsible for the Tylenol recall in Sept 2009 (which still has ongoing problems, apparently). According to him, the J&J subsidiary (McNeil) appointed a new vice president of quality assurance, a new vice president of operations, a new plant manager for the Fort Washington location, and a new head of quality for the same plant immediately after the recall. Then there was the testimony (pdf) of Ms Colleen A. Goggins, Worldwide Chairman, Consumer Group, Johnson and Johnson. According to her, the FDA was informed of the [Tylenol] recall (which happened in September of that year), by an April 21, 2009, Field Alert to the FDA's San Juan office. She stated that she only was aware the Committee might be interested in the use of a third-party contractor for carrying out the [phantom/Motrin] recall, on the morning of her first testimony, and had never before seen the subcontractor documents shown to her during that first investigation either. She ended her (short) testimony with announcing her retirement from Johnson & Johnson, after nearly 30 years with the company. Josua Sharfstein represented (pdf) the Food and Drug Administration in this hearing. He offered a brief update on the current ongoing FDA investigation related to the case — starting out by saying that the agency couldn't establish a direct link between the "several recalls" and any serious adverse events, including death. Products coming from the Las Piedras facility had a musty, moldy odor, later identified to be coming from a pesticide (TBA, 2, 4, 6-Tribromoanisole) used to treat the wooden pallets. The FDA had issued a warning about the matter to McNeil on Jan 25, and was currently in the process of doing a follow-up inspection of the facility. Mr Sharfstein specifically mentioned "the breakdowns in leadership and oversight that led to these serious compliance problems", questioning whether "McNeil's corporate culture supported a robust quality system to ensure the purity, potency, and safety of its products."