February 2007

BACKGROUND: The Fair Access to Clinical Trials Act, S. 467, was introduced in the Senate by Senators Dodd (D-CT), Wyden (D-OR), Harkin (D-IA), Durbin (D-IL), Bingaman (D-NM) and Grassley (R-IA). The bill will amend the Public Health Service Act to expand the clinical trials drug data bank. It creates a publicly accessible national data bank of clinical trial information comprised of a clinical trial registry and a clinical trial results database. The database will include all publicly and privately funded clinical trial results regardless of outcome.

S. 467 has 6 cosponsors. And has been referred to the Senate Committee on Health, Education, Labor, and Pensions. There is no companion bill yet in the House.

WHAT CAN YOU DO? Contact your representative to request his/her support for S. 470. Call 1-202-224-3121 to reach the Capitol Switchboard, and ask for your representative’s office. When connected to the office, ask for the Health Legislative Assistant. If you leave a voicemail message, include your name and phone number.

TALKING POINTS:

• I am a practicing child and adolescent psychiatrist in (your state) and I am calling to ask Senator_____ to support S. 467, The Fair Access to Clinical Trials Act because physicians and parents need access to clinical trials data in order to make fully informed decisions about treatments.
• This bill will preserve access to a complete range of treatment options, including medication, is necessary to save patients’ lives and treat their illnesses.
• The general public is also entitled to accurate and timely information regarding the safety and efficacy of medications, and published literature often does not contain full and complete reports of all research studies or clinical trials conducted on specific medications.
• A mandatory, publicly accessible national registry of clinical trials is vital to promoting access to clinical trials data, including data from negative trials and unpublished research.
• Congress should also call for and fund further research to help us better understand the effectiveness and safety of antidepressant medications and their use in children. I urge the formation of a pediatric and adolescent Central Nervous System Advisory Committee at the FDA comprised of experts including child and adolescent psychiatrists and pediatric neurologists.

Please contact the AACAP Department of Government Affairs & Clinical Practice if you have any questions via e-mail at erorick@aacap.org.