1. Over-the-Counter Cough and Cold Products for Children Under Age 6 Joshua M. Sharfstein, M.D. Commissioner of Health Baltimore, Maryland October 18, 2007

2. Background 1 year ago next week (October 26, 2006) –9 chiefs of pediatrics in the Baltimore area –The Maryland Chapter of the American Academy of Pediatrics –Johns Hopkins pediatrician Dr. Janet Serwint –Baltimore City Health Department All joined together to issue an advisory to parents to “not use over-the-counter cough and cold medication for children ages five and under.”

3. If so many experts advise against these medications for young children, why are they so widely marketed and used?

4. Widely Marketed From July 1, 2006 to June 30, 2007, companies spent more than $51 million advertising over-the-counter pediatric cough and cold medications* Marketing themes: –Safe and effective –Pediatricians recommend –Parents can relax *The Prescription Project, Boston, MA using data from TNS Media

5. Parenting, February 2006 “For both babies and big kids, pediatricians recommend Pediacare most. And that makes their Moms feel pretty good, too.”

6. American Baby, January 2006 “And like all our Little Remedies cough, cold and fever products, they contain safe, effective, pediatrician recommended ingredients without additives.”

7. American Baby, March 2005

8. “Mom worries when a cold makes it hard for her kid to breathe. Unless, of course, she has Dimetapp.” Woman’s Day Magazine November 1, 2007

9. “Nothing is easier to give your infant to get them bouncing around again than the two new formulas of Infant Triaminic Thin Strips. Triaminic. The Medicine of Motherhood.” $2 million spent marketing Triaminic infant thin strips in Fiscal Year 2007* Parenting, November 2006 *The Prescription Project, Boston, MA using data from TNS Media

10. Widely Used Source: Consumer Healthcare Products Association, Submission to FDA, October 2007, p. 9 95 million units of pediatric OTC cough and cold products sold annually 39% of households 44 million buyers

11. If so many experts advise against these medications for young children, why are they so widely marketed and used?

12. The Answer: A Gap in Federal Oversight FDA did not approve these products on the basis of evidence of safety or effectiveness in children FDA has permitted widespread marketing that is not supported by scientific evidence

13. History 30 years ago, a different advisory panel Start of the OTC monograph for cough and cold medications Panel found that evidence in children for these drugs was “negligible or nonexistent”

14. Since 1976 FDA permitted marketing under classification of “generally recognized as safe and effective” (21 CFR 340.1). In recent years: –Doctors report serious injuries and death –Studies fail to show effectiveness in children –Medical authorities express concern American Academy of Pediatrics American College of Chest Physicians Centers for Disease Control and Prevention

15. To ask FDA to review the data To hold these products to an appropriate standard for medicine given to young children Over-the-counter cough and cold products for children under age 6 do not meet this standard

16. Efficacy Wayne R. Snodgrass, M.D., Ph.D. –Professor, Departments of Pediatrics, Pharmacology and Toxicology University of Texas Medical Branch –Chair, Committee on Drugs, American Academy of Pediatrics

17. Safety Michael Shannon, M.D., M.P.H. –Professor of Pediatrics Harvard Medical School –Chair, Division of Emergency Medicine, Boston Children’s Hospital

18. Practical Considerations Daniel J. Levy, M.D., F.A.A.P. –President, Maryland Chapter, American Academy of Pediatrics –In private practice for 30 years –Avid baseball fan