5/5/10 The Honorable (name of your representative) Address of representative Dear Representative (name of your representative): I am writing to you about
McNeil Consumer Healthcare’s voluntary product recall on April 30th 2010. As a concerned parent, conscientious consumer, and constituent of your district, I am petitioning your assistance in obtaining information that the public, particularly parents who gave their children the flawed medicine, deserve. The FDA has not adequately fulfilled its obligation to protect and inform the consumer. The FDA report on the factory, although extensive, still raises several questions about the flaws of the products and their possible negative effects on consumer health. The FDA has presented no scientific evidence that substantiates the claim that the possibility of “serious health problems” from ingesting the flawed products is “remote.” Furthermore, considering that the vastness of the product recall complicates the identification of the medicine’s resultant health problems, the FDA must provide an explicitly stated reparatory procedure outlining the identification and treatment of consumer health issues caused by McNeil Consumer Healthcare products. Thus far, the FDA has only provided a means for the consumer to report possible negative effects. Specific questions derived from these general concerns are listed below. Please give them due diligence.
1. How has the FDA come to the conclusion that “serious health problems are remote”?
2. How widespread are the contaminated products? How long have these contaminated products been on the market? 3. If the FDA states that testing done to date has not found B. cepacia bacteria in finished products, what continual testing procedures will be implemented to definitively prove that it did not reach the products? 4. What are the metal particles in the medicine? What possible negative health effects, if any, can they cause? 5. How will the FDA educate consumers and train pediatricians to identify possible health issues caused by any of the medicine’s flaws or contaminants (i.e. – metal particles, B. cepacia bacteria, liver issues caused by excessive acetaminophen)? If this information is already available, please provide access to it. 6. If these issues are medically and professionally identified and the causes traced to the contaminated medicine, how will the FDA or McNeil Consumer Healthcare provide proper treatment to the consumer? Thank you for your time and consideration. Sincerely yours, Name Address