BIO Letter of Support for H.R. 2857, the Pediatric Research Equity Act of 2003

The Honorable James Greenwood
2436 Rayburn House Office Building
U.S. House of Representatives
Washington, DC 20515

The Honorable Anna Eshoo
205 Cannon House Office Building
U.S. House of Representatives
Washington, DC 20515

The Honorable Deborah Pryce
221 Cannon House Office Building
US House of Representatives
Washington, DC 20515

Dear Representatives Greenwood, Eshoo and Pryce:

On behalf of the Biotechnology Industry Organization (BIO), I am writing to thank you for introducing H.R. 2857, the Pediatric Research Equity Act of 2003. BIO looks forward to working with you to enact this bill into law this year.

Congress took an important step in addressing the need to improve scientific and medical information on the safety and effectiveness of drugs in the pediatric population with enactment of the Better Pharmaceuticals for Children Act in 1997 and its reauthorization, the Best Pharmaceuticals for Children Act (BPCA), in 2002. Passage of these bills authorized the Food and Drug Administration to grant six months of market exclusivity to products on which FDA-approved pediatric studies have been conducted and established a public-private partnership to fund such studies on older drug products no longer on patent.

H.R. 2857 takes the next important step by authorizing FDA to require pediatric studies and information for drugs and biological products in cases where the needed information is not generated by using the existing incentive and funding mechanisms. BIO applauds the Senate's passage of similar legislation (S. 650) earlier this year, and urges the House to act soon on this important issue.

Thank you again for your leadership the Pediatric Research Equity Act, and on other issues important to the biotechnology industry. Please call me at (202) 962-9200 if you have any questions, or would like additional information. We look forward to working with you to pass H.R. 2857 this year.

Sincerely,

Sharon L. Cohen
Vice President
Federal Government Relations

cc:

The Honorable Billy W.J. Tauzin
The Honorable Michael Bilirakis
The Honorable John Dingell
The Honorable Sherrod Brown