TO; Mr. Woods, Chief FDA
FROM: Hansen, Employee FDA
DATE: October 24, 2010
SUBJECT: Robins and Robins Case.
The Robins and Robins case has led to several activist groups calling for FDA's liability for the death of 12 children. They point to FDA's fault and negligence in not passing the original tracking bar rule. It is contended that FDA does not have any liability to the victims of Robins and Robins medicine poisoning.
Three over the counter medicines being sold by Robins and Robins have been tainted with plastic explosives. This contamination has led to 1400 children and 350 adults being hospitalized. The company Robins and Robins has recalled it medicines but since there is no special tracking bar code on the medicine the recall is not automatic and several people have consumed the contaminated medicine.
You will recall that last year FDA had promulgated an administrative rule that stated that all pharmaceutical companies that sold over the counter medications must bear a special tracking bar cod on all packaging so that the recall could be automatic. The firm Robins and Robins lobbied against this rule and got the rule stopped during the public comments period.
FDA did the right thing in stopping the bar code rule because the public felt that it could violate the privacy of individuals, and would needlessly increase the cost of over the counter drugs. Further there were a large number of public interest groups that lobbied against the rule.
The death and illness have been caused because of the negligence of Robins and Robins and not the FDA. In response to the concerns of public interest groups the FDA has stopped the rule.
The defense that FDA has is that the rule was created by FDA itself. However, the imposition of the rule was set aside because of protests from public interest groups. Further, Section 402 (a) applies to food and not to medicine. Since, Robins and Robins was the strongest opponent to the rule requiring tracking code, the negligence claim should be against Robins and Robins and not against the FDA. It is clear that had Robins and Robins not lobbied the lives of the children could have been saved.
References: www.fda.gov/ www.fda.gov/Food/default.htm www.accessdata.fda.gov/scripts/cder/drugsatfda/ www.fda.com/ - www.fdanews.com/ 