WASHINGTON - "This is a company that had a major problem with compliance."
Stark words about one of the nation's most trusted companies, Johnson & Johnson, delivered by Dr. Joshua Sharfstein, FDA's Principal Deputy Commissioner.
Sharfstein told the House Committee on Oversight and Government reform that the company's McNeil Pharmaceutical division could be subject to criminal penalties for a "pattern of non-compliance".
136 million bottles of Children's Tylenol, Motrin, Zyrtec and Benadryl were recalled in April because of metal and other particles, risk of bacterial contamination, and the possibility too much active ingredient.
There have been three major recalls of McNeil over-the-counter medicines in the last nine months.
Sharfstein said McNeil's Ft. Washington, PA plant had a stepped up inspection schedule because of several violations prior to 2009.
"I think as manufacturing problems go, they were serious." Sharfstein told committee chairman Rep. Edolphus Towns.
He also revealed a troubling document related to problems with packets of Motrin in 2008. The medicine did not dissolve properly, according to Sharfstein. McNeil allegedly told the FDA it would evaluate how much product was in distribution, to see if there was a need for recall.
Sharfstein testified that McNeil told field workers to do something else: buy up all the product.
"You should simply act as a regular customer while making these purchases. There must be no mention of this being a recall of the product. If asked, simply state your employer is checking the distribution chain of this product and needs to have some of it purchased for the project." read Sharfstein.
Johnson & Johnson's Colleen Goggins, Worldwide Chairman of J&J's Consumer Group responded to questions from Towns:
"I know nothing about that, sir. I know only that we were in discussions with the FDA in San Juan over the product issue and how we were planning to handle it with a third party contractor."
Goggins testified that the issue involved only a small number of individual packets, sold at gas stations in Puerto Rico, and said there was "never any intent to mislead or hide anything from anyone."
Johnson & Johnson says the health risks to consumers are remote, and the FDA agrees. So far the agency has not found any "serious" health effects connected to ingestion of the medicines, though it has logged hundreds of reports on its website since the recall was announced. Many of the complaints, explained Sharfstein, were what would be considered "side effects" rather than serious adverse events.
The death of a 6 year old child in January 2010 from a bacterial infection of Burkholderia cepacia is not believed to be not related.
B. cepacia is the same bacteria the agency says the children's medicines were at risk of contamination from. However, testing of the medicines the child ingested for b. cepacia came back negative.
Sharfstein says the agency is still waiting for a final autopsy report, and is still investigating other serious adverse event reports.
Dr. Daniel Fagbuyi, an attending physician at Children's National Medical Center has been re-assuring nervous parents that generic alternatives are available and acceptable to treat their little ones' ailments.
"Look if you have these medicines on your shelf, take them and throw them away. Go look for the generic brands; go pick those up if you need them. If you still have any doubt or you're just not sure, call your health care provider and they'll be able to clarify those issues for you."
Still, as parent of three small children himself, the suggestion that a trusted company may not be so trust-worthy is concerning.
"Of course, as with anything.. no matter what kind of recall it is, if it's furniture, if it's medication in this case, safety is the number one priority." says Fagbuyi.
For now, McNeil's Ft. Washington plant is shut down. Johnson & Johnson says it has replaced key personnel in at least six areas, and will deliver a comprehensive plan to get its plant up and running compliantly, on July 15.
It may take longer than that for consumers to feel comfortable that the company has fixed its medicines, and its reputation
For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch .
LINKS:
Children's Medicine Recall
www.mcneilproductrecall.com
Adverse Reactions Should Be Reported To FDA:
www.fda.gov/medwatch
Proper Disposal:
www.smartrxdisposal.net
Tylenol Recall 1/15/2010
http://www.mcneilproductrecall.com/page.jhtml?id=/include/prd_tylenol.inc
QUESTIONS AND ANSWERS:
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