There will be a hearing before Congress on May 27, 2010 to address the recent recall of Children’s Tylenol, Motrin, Zyrtec, and Benadryl medications. Despite a request to postpone the hearing by Darrell Issa the House Committee on Oversight and Government Reform’s ranking member, the hearing will proceed as planned on Thursday. Issa had requested holding off on the hearing because Johnson & Johnson CEO Bill Weldon was unable to attend. Weldon is recovering from a conveniently scheduled back surgery. Johnson & Johnson’s McNeil Consumer Healthcare unit is one target of the probe by the Congressional panel. The FDA has also not completed their investigation at the McNeil plant. Their investigation will continue even as the hearing begins before Congress.
A congressional memo prepared for the hearing characterized the recent recall of Children’s Tylenol, Motrin, Zyrtec, and Benadryl as “the largest recall of children’s medicine in the history of the FDA.”
Johnson & Johnson CEO Weldon had been called to testify, but due to the surgery can’t put in an appearance. He did release a statement declaring his intention to cooperate with the House Committee on Oversight and Government Reform, saying he would testify at a later date. However, Committee Chairman Edolphus Towns has refused to delay the hearing on the Children’s Tylenol, Motrin, Zyrtec, Benadryl recall believing the situation to be so serious at Johnson & Johnson and McNeil Consumer Healthcare that the hearing must be held immediately in order to protect the safety of consumers.
“”Taken together, these recalls point to a major problem in the production of McNeil products,” Towns said in a statement to the public.”Given McNeil’s questionable track record and consecutive recalls, we need to understand what prior actions the FDA took to address McNeil’s quality control problems and what events led the FDA to its April 2010 inspection of McNeil’s Fort Washington plant.”
Given the powerful company he is dealing with, it is admirable that Towns is not caving in to pressure to delay the hearing. However, it is troubling that the hearing is going to proceed given the FDA has not completed their final investigations of McNeil Consumer Healthcare and Johnson & Johnson. The FDA is now calling for more inspections and an independent audit of another Johnson & Johnson unit. So it seems that the manufacturing issues at Johnson & Johnson go deeper than earlier believed. Johnson & Johnson had stated that the problems with quality control and safety were due to problems at the McNeil plant and not because of any oversight on the part of Johnson & Johnson. That FDA’s recent findings seem to call these statements into question. It has been alleged that Johnson & Johnson gives its subsidiaries too much autonomy and doesn’t properly monitor them or hold them accountable for minimum standards.
The House Committee on Oversight and Government Reform have requested information and records from FDA Commissioner Margaret Hamburg in order to try and clarify the timing of the events of the Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall of May 2010. They are trying to understand Johnson & Johnson’s and the FDA’s response to consumer complaints and to findings of bacteria, super potent medications, and metallic particles in medications. They also are asking Hamburg to identify the bacteria found in raw materials at McNeil’s Fort Washington, Pennsylvania plant. The facility is the only plant in the U.S. that manufactures Children’s Tylenol, Motrin, Zyrtec, and Benadryl.
The Congressional hearing will investigate “the adequacy of the FDA’s inspection procedures and whether J&J’s McNeil unit failed to investigate consumer complaints that could have identified the contamination problems,” sooner than reported.
Scheduled to testify at Thursday’s Congressional hearing on behalf of Johnson & Johnson is Colleen Goggins worldwide chairman of J&J’s consumer group. Dr. Joshua Sharfstein principal deputy Commissioner, Deborah Autor, Director of the office of compliance and Michael Chappell, acting commissioner for regulatory affairs, will testify for the FDA.
For More Information About the Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 See the Following Articles:
Congressional Memo Reveals Bacterial Contamination Dates to 2009
Congressional Panel to Investigate Recall of Children’s Medications
How to Request a Refund from McNeil Consumer Healthcare
Children’s Tylenol, Motrin, Zyrtec, Benadryl Recall 2010 Expanded