Washington, conducted in November 2010, required 25 full-day visits from FDA inspectors. In October of that same year, the FDA had conducted a 19-day inspection of McNeil’s Tylenol manufacturing plant in Las Piedras, Puerto Rico. But on October 1, 1982, just two days after the Tylenol murders, the FDA claimed to have already determined that the tamperings could not have happened within Johnson & Johnson’s manufacturing and distribution network. The FDA was astonishingly ill equipped to make any such determination.
In a report to the U.S. Congress on April 26, 1982, the U.S. Government Accountability Office (GAO) stated that the FDA could only estimate that somewhere around 200,000 to 300,000 OTC drug products were on the market. The GAO concluded: “Without information on the number of OTC products marketed, the FDA is unable to evaluate the relative magnitude of any identified problem with an OTC product. The net effect is that FDA is unaware of (1) the number of individual OTC products currently being marketed and (2) whether these products are safe and effective as determined by any type of FDA review.”
Incredibly, up until 1997, the FDA had no statutory authority to inspect records or documents at OTC drug manufacturing plants. The FDA could inspect only those records that were on display at the time of the inspection or voluntarily provided by the manufacturer. Companies like Johnson & Johnson were not inclined to provide this type of information to the FDA. Large manufacturers, said the FDA, were more likely than small ones to provide only limited access or no access at all to current Good Manufacturing Practices (cGMP) related documents.
After an investigation of the FDA’s procedures for monitoring OTC drugs in 1991, the GAO concluded that the FDA might be unable to fully protect public safety and health or validate compliance with the cGMP regulation, and thus, validate an OTC company’s ability to produce a quality product. The GAO determined that the lack of full access to OTC drug manufacturers’ records and files limited the FDA’s ability to evaluate the effectiveness of these manufacturers’ efforts to analyze complaints, remedy problems, and generally produce a safe and effective product. In effect, reported the GAO, the current situation hindered the FDA from fully carrying out its mandate to protect the public health and provide reasonable assurance of the safety and effectiveness of OTC drugs.
The FDA never even had access to the nearly 300 consumer complaints of Tylenol tamperings, mix-ups, and contaminations that Johnson & Johnson had received in the three years prior to the Tylenol murders. The existence of these complaints was not disclosed until 1991 after J&J had been forced to turn them over to the lawyers handling the lawsuits filed by relatives of the Tylenol murders victims.
By clearing Johnson & Johnson so quickly, without conducting an investigation of the McNeil plants, the FDA may have provided a hint as to the location where the tamperings actually occurred. The FDA may have known all along that an inspection of the McNeil plants was unnecessary, because the adulterated Tylenol had not been bottled there. FDA officials cleared the McNeil plants, but they never said the Tylenol had not been poisoned at a repackaging facility or distribution center in Johnson & Johnson’s channel of distribution.
Instead of bringing in FDA officials to inspect the McNeil manufacturing plants; J&J flew in Cook County Toxicologist, Michael Schaffer, on Monday, October 4 th , to conduct a half-day “inspection” of McNeil’s 375,000 square-foot Tylenol manufacturing plant in Fort Washington. Schaffer spent just a few hours at the sprawling plant before declaring, “No human hands touched the Tylenol or its ingredients in the automated mixing and packaging process.” Schaffer then added, “I don’t think it’s impossible, but it’s a million to one” that the contamination occurred at
In a report to the U.S. Congress on April 26, 1982, the U.S. Government Accountability Office (GAO) stated that the FDA could only estimate that somewhere around 200,000 to 300,000 OTC drug products were on the market. The GAO concluded: “Without information on the number of OTC products marketed, the FDA is unable to evaluate the relative magnitude of any identified problem with an OTC product. The net effect is that FDA is unaware of (1) the number of individual OTC products currently being marketed and (2) whether these products are safe and effective as determined by any type of FDA review.”
Incredibly, up until 1997, the FDA had no statutory authority to inspect records or documents at OTC drug manufacturing plants. The FDA could inspect only those records that were on display at the time of the inspection or voluntarily provided by the manufacturer. Companies like Johnson & Johnson were not inclined to provide this type of information to the FDA. Large manufacturers, said the FDA, were more likely than small ones to provide only limited access or no access at all to current Good Manufacturing Practices (cGMP) related documents.
After an investigation of the FDA’s procedures for monitoring OTC drugs in 1991, the GAO concluded that the FDA might be unable to fully protect public safety and health or validate compliance with the cGMP regulation, and thus, validate an OTC company’s ability to produce a quality product. The GAO determined that the lack of full access to OTC drug manufacturers’ records and files limited the FDA’s ability to evaluate the effectiveness of these manufacturers’ efforts to analyze complaints, remedy problems, and generally produce a safe and effective product. In effect, reported the GAO, the current situation hindered the FDA from fully carrying out its mandate to protect the public health and provide reasonable assurance of the safety and effectiveness of OTC drugs.
The FDA never even had access to the nearly 300 consumer complaints of Tylenol tamperings, mix-ups, and contaminations that Johnson & Johnson had received in the three years prior to the Tylenol murders. The existence of these complaints was not disclosed until 1991 after J&J had been forced to turn them over to the lawyers handling the lawsuits filed by relatives of the Tylenol murders victims.
By clearing Johnson & Johnson so quickly, without conducting an investigation of the McNeil plants, the FDA may have provided a hint as to the location where the tamperings actually occurred. The FDA may have known all along that an inspection of the McNeil plants was unnecessary, because the adulterated Tylenol had not been bottled there. FDA officials cleared the McNeil plants, but they never said the Tylenol had not been poisoned at a repackaging facility or distribution center in Johnson & Johnson’s channel of distribution.
Instead of bringing in FDA officials to inspect the McNeil manufacturing plants; J&J flew in Cook County Toxicologist, Michael Schaffer, on Monday, October 4 th , to conduct a half-day “inspection” of McNeil’s 375,000 square-foot Tylenol manufacturing plant in Fort Washington. Schaffer spent just a few hours at the sprawling plant before declaring, “No human hands touched the Tylenol or its ingredients in the automated mixing and packaging process.” Schaffer then added, “I don’t think it’s impossible, but it’s a million to one” that the contamination occurred at
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