H R 2887 in Congressional Session 107

Bill Number : H R 2887

Title : To amend the Federal Food, Drug, and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children.

SUMMARY AS OF:
11/15/2001--Passed House amended.    (There are 2 other summaries) Best Pharmaceuticals for Children Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services, through the National Institutes of Health (NIH), to develop an annual list of approved drugs for which: (1) there is a referral, an approved or pending new drug application, or no patent or market exclusivity protection; and (2) additional pediatric safety and effectiveness studies are needed. Directs the Secretary to award contracts to entities with appropriate experience for pediatric clinical trials of such drugs. Requires the results of such trials to be reported to the Commissioner of Food and Drugs who shall then determine and request any necessary labeling changes. Authorizes the Commissioner to deem a drug misbranded if the holder of an approved application refuses to make the requested change. Requires the Secretary to send a nonbinding letter of recommendation to an approved application holder if such studies indicate a reformulation is necessary. Sets forth reporting, label change, and dispute resolution requirements. Maintains the confidentiality of commercial information or trade secrets. Authorizes appropriations.

(Sec. 4)

Amends the Federal Food, Drug, and Cosmetic Act to set forth procedures for written requests for pediatric studies to holders of approved applications for drugs that have market exclusivity. Requires the Secretary to refer such drugs to the Foundation for Pediatric Research for pediatric studies if the need for more information continues and the holder refuses. Directs the Secretary to refer such drug onward to the Public Health Service list if the Foundation has insufficient funds to conduct the study.

(Sec. 6)

Directs the Secretary to establish an Office of Pediatric Therapeutics within the Office of the Commissioner of Food and Drugs, which shall coordinate all FDA pediatric activities.

(Sec. 7)

Amends the Federal Food, Drug, and Cosmetic Act to: (1) eliminate the user fee waiver for pediatric supplements to a human drug application; (2) provide priority status for pediatric supplements; (3) include neonates within age groups for pediatric studies; (4) provide for dissemination of pediatric supplement information; and (5) set forth requirements for the additional six-month exclusivity period for new or already-marketed pediatric drugs.

(Sec. 11)

Requires only an abbreviated application for new drug approval for generic drugs with added pediatric information.

(Sec. 12)

Establishes an adverse reaction toll-free number which must appear on the labels of drugs approved under new drug application procedures. Requires that adverse effects from drugs with pediatric market exclusivity be reported to and reviewed by the Office of Pediatric Therapeutics.

(Sec. 13)

Amends Title IV of the Public Health Service Act to direct the Secretary to establish the Foundation for Pediatric Research to collect funds and award grants for research on drugs lacking exclusivity for which pediatric studies are needed. Requires that the result of such studies be submitted to the Director of NIH and the Commissioner.

(Sec. 14)

Directs the Secretary to contract with the Institute of Medicine to review Federal regulations, reports, and support for research involving children, with particular attention to issues of compensation, informed consent, and risk/ benefits assessments in terms of research versus therapeutic treatment.

(Sec. 15)

Requires the Comptroller General to report to Congress and the Secretary on the effectiveness of this Act in ensuring that all drugs used by children are tested and properly labeled. Requires such report to also include an assessment of: (1) this Act's economic impact; (2) the complexity of the pediatric drug studies; and (3) increased pediatric research ability.

(Sec. 16)

Directs the Comptroller General to study and report on the representation of ethnic and racial minority children in such studies.

Rep Brady, Robert A. [PA-1] - 9/13/2001

Rep Buyer, Steve [IN-5] - 9/13/2001

Rep Capuano, Michael E. [MA-8] - 11/7/2001

Rep Dooley, Calvin M. [CA-20] - 10/17/2001

Rep Eshoo, Anna G. [CA-14] - 9/13/2001

Rep Fattah, Chaka [PA-2] - 10/4/2001

Rep Frank, Barney [MA-4] - 9/25/2001

Rep Kind, Ron [WI-3] - 11/8/2001

Rep Lantos, Tom [CA-12] - 11/1/2001

Rep Lofgren, Zoe [CA-16] - 9/13/2001

Rep McGovern, James P. [MA-3] - 10/17/2001

Rep Morella, Constance A. [MD-8] - 10/10/2001

Rep Owens, Major R. [NY-11] - 10/10/2001

Rep Rangel, Charles B. [NY-15] - 9/24/2001

Rep Roukema, Marge [NJ-5] - 9/20/2001

Rep Roybal-Allard, Lucille [CA-33] - 9/13/2001

Rep Rush, Bobby L. [IL-1] - 9/13/2001

Rep Smith, Christopher H. [NJ-4] - 9/24/2001

Rep Upton, Fred [MI-6] - 9/13/2001

Rep Whitfield, Ed [KY-1] - 10/4/2001

Rep Woolsey, Lynn C. [CA-6] - 10/4/2001

Rep Wynn, Albert Russell [MD-4] - 9/13/2001