DeLauro Calls for Better Recall Process, Inspections

DeLauro Calls for Better Recall Process, Inspections
Writes to FDA Commissioner in wake of Tylenol recalls
Washington, DC- Congresswoman Rosa DeLauro (CT-3), Chairwoman of the Agriculture and FDA Appropriations Subcommittee, sent a letter to FDA Commissioner Margaret Hamburg today calling for a review of the agency's response to the recent Tylenol recall, specifically their inspection and oversight processes.

Johnson & Johnson, the makers of Tylenol, recalled over 40 different types of over-the-counter medications earlier this week due to quality control failures. The contaminated products, which include children's and infant's Tylenol products, were produced during a time period when the company was receiving consumer complaints.

The text of the letter is below.

May 7, 2010

Margaret Hamburg, M.D. Commissioner U.S. Food and Drug Administration U.S. Department of Health and Human Services 10903 New Hampshire Ave Silver Spring, MD 20993-0002

Dear Dr. Hamburg:

I am writing to express concern about the events surrounding the April 30th recall by McNeil Healthcare, LLC of 43 over the counter medications for infants and children. I commend the agency for its inspection of the McNeil facility in Pennsylvania and the timely response that led to this voluntary recall. However, I am concerned that the agency does not possess the authority to take appropriate action to address potentially criminal behavior by a corporation. I also have several questions about what can be done to monitor drug production facilities, and how information about this recall is being communicated to consumers.

Based on initial published reports, the corporate oversight observed at this facility appears to be symptomatic of reckless behavior that is clearly unacceptable. Several of the observations made during the April inspection are similar to observations from 21 days of inspection at another McNeil Healthcare facility between October 2009 and January 2010. The blatant disregard for the required Current Good Manufacturing Practice regulations at both facilities is both unnerving and unethical. Even more alarming is the indication that this is a recurring problem at the facility, as supported by the September 2005 recall of Children's Motrin produced at the Fort Washington plant.

While the FDA routinely inspects drug manufacturing facilities, some of the observations in the initial report are especially alarming and may reflect a systemic problem. For example, the FDA inspection team noted that "adequate lab facilities for testing and approval or rejection of components and drug products [were] not available." Facility staff was also observed breaking standard lab practices and multiple procedures were disregarded - either intentionally or accidentally - by staff across the facility. The initial report from FDA inspectors notes that there were not even "written procedures...to assure that the drug products have the identity, strength, quality, and purity they purport...to possess."

The products that were manufactured at this facility and later recalled were intended to treat infants and children. While there are some concerns about the use of cold medications in children of some ages, this case introduces an especially alarming component to that debate because this facility potentially could have been selling products of varying strengths and quality. Parents rely on product consistency when following the dosing instructions in these over the counter products or the recommendations from their pediatrician, but this facility did not monitor these valuable parameters.

In addition to the general concerns outlined above, I am requesting responses to the following questions related to this situation.

  • The FDA does not currently have the authority to mandate a recall of any drugs, including drugs meant for infants and children. Would enhancing any of the FDA's regulatory authorities improve the agency's ability to quickly and effectively recall drugs? What is FDA doing to ensure that all of the recalled products are removed from stores shelves? If the FDA investigation determines that criminal behavior may have been involved, will the agency recommend to the Department of Justice that fines should be imposed and criminal charges be pursued? Monitoring increases in consumer complaints played a critical role in this incident and the earlier incident this year of other McNeil products. Should the FDA require facilities to more effectively monitor trends such as consumer complaints? Would this type of post-market surveillance be best performed by private companies or the agency? What can be done to enhance the agency's ability to effectively monitor drug production and actual practices at domestic facilities? How often does the FDA routinely inspect drug manufacturing facilities? Does that frequency change for higher risk facilities, like those of a company that has significant problems at another facility? Please provide a comprehensive background on FDA's inspection of drug manufacturing facilities. Please provide the facility inspection schedule and relevant records from the inspections conducted, including, but not limited to, inspection observations, narratives, and any company responses. It is vital that information about the recalled products get communicated to consumers immediately. Comprehensive information online is certainly a part of this equation, but clear and accurate information communicated through informal networks to reach consumers is equally important, especially in areas with limited access to broadband service. What is FDA doing to ensure that information about this recall reaches all American consumers? Is FDA working with state health departments to ensure consumers are informed?

Thank you for your attention to this issue. I look forward to the responses to these questions and to working with you to resolve these issues. Sincerely,

ROSA L. DeLAURO Chairwoman House Appropriations Subcommittee on Agriculture Rural Development, Food and Drug Administration, and Related Agencies

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