Eschenbach Letter

CHADD's Letter to Dr. Andrew Eschenbach and FDA Response

October 17, 2006

Andrew C. von Eschenbach, M.D.
Acting Commissioner U.S Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857-0001

Dear Commissioner Eschenbach:

In light of the recent Los Angeles Times article, "FDA Budget Malnourished: A study of ADHD drug risks may be halted as the agency struggles to keep up with demands" (October 7, 2006), CHADD is writing to urge that this study be completed and published as soon as possible.

CHADD is a family based organization with 14,000 members. Both the National Institute of Mental Health in its Multi-modal Treatment (MTA) study on AD/HD and the Surgeon General’s Report on Mental Health emphasize that the safety and efficacy of medication is of paramount importance to parents, patients, and doctors alike. Given the highly publicized accounts of possible cardiac and other health related risks possibly associated with some medications needed to treat ADHD, we believe the FDA must complete this study to ensure that any risks are accurately assessed and the facts discovered and released. Halting this study could reinforce a growing public concern about effective treatments for AD/HD while completing the study will allow doctors and patients and their families to make informed choices about needed and effective medications for AD/HD.

Thank you for considering our views.

Sincerely,

E. Clarke Ross, D.P.A.

CHADD CEO
4601 Presidents Drive, Suite 300
Lanham, MD 20706

Email Response from the FDA

From: CDER DRUG INFO [mailto:DRUGINFO@cder.fda.gov]
Sent: Tuesday, November 07, 2006 2:21 PM
To: Clarke Ross
Subject: Los Angeles Times article

Dear E. Clarke Ross:

On behalf of Dr. Andrew C. von Eschenbach, Acting Commissioner, and the Center for Drug Evaluation and Research (CDER), I would like to thank you for making your thoughts known to the Agency regarding the October 7, 2006, Los Angeles Times article entitled "FDA Budget Malnourished: A study of ADHD drug risks may be halted as the agency struggles to keep up with demands."

We appreciate your thoughts and suggestions regarding this issue and will contact you in the future if you can be of assistance.

Thank you again.

Sincerely,

Donald Dobbs
Division of Drug Information (HFD-240)
Office of Training and Communications Center for Drug Evaluation and Research Food and Drug Administration