Best Pharmaceuticals for Children Act

Summary

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, to develop a list of approved drugs for which: (1) there is no patient 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. Establishes a Food and Drug Administration (FDA) contract process for related labeling changes. 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 the definition of 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. 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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 7 May 2001

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S4422-4424)

   Source: IntroReferral

2. 7 May 2001

   Introduced

   Sponsor introductory remarks on measure. (CR S4422)

   Source: IntroReferral

3. 7 May 2001

   Introduced

   Introduced in Senate

   Source: IntroReferral

4. 1 August 2001

   Reported

   Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

   Source: Committee

5. 4 October 2001

   Calendars

   Placed on Senate Legislative Calendar under General Orders. Calendar No. 184.

   Source: Calendars

6. 4 October 2001

   Reported

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute. With written report No. 107-79.

   Source: Committee

7. 4 October 2001

   Reported

   Committee on Health, Education, Labor, and Pensions. Reported by Senator Kennedy with an amendment in the nature of a substitute. With written report No. 107-79.

   Source: Committee

8. 18 October 2001

   Reported

   Measure laid before Senate by unanimous consent. (consideration: CR S10816-10819; text of measure as reported: CR S10816-10818)

   Source: Floor

9. 18 October 2001

   Passed

   Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.

   Source: Floor

10. 23 October 2001

    Floor

    Held at the desk.

    Source: Floor

11. 23 October 2001

    Floor

    Message on Senate action sent to the House.

    Source: Floor

12. 23 October 2001

    Floor

    Received in the House.

    Source: Floor

Votes

No vote records are attached yet.

Versions

• Engrossed in Senate · 18 October 2001 · Official file
• Reported to Senate · 4 October 2001 · Official file
• Introduced in Senate · 7 May 2001 · Official file

Documents

9 official files

• Engrossed in Senate (text)

  Engrossed in Senate · EN · 18 October 2001

  ViewDownloadOpen at official source

• Engrossed in Senate (PDF)

  Engrossed in Senate · EN · 18 October 2001

  ViewDownloadOpen at official source

• Passed Senate amended

  summary · EN · 18 October 2001

  Open at official source

• Reported to Senate (text)

  Reported to Senate · EN · 4 October 2001

  ViewDownloadOpen at official source

• Reported to Senate (PDF)

  Reported to Senate · EN · 4 October 2001

  ViewDownloadOpen at official source

• Reported to Senate with amendment(s)

  summary · EN · 4 October 2001

  Open at official source

• Introduced in Senate (text)

  Introduced in Senate · EN · 7 May 2001

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 7 May 2001

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 7 May 2001

  Open at official source

Sponsors

• Rep. Dodd, Christopher J. [D-CT-2] · D · Sponsor
• Rep. DeWine, Mike [R-OH-7] · R · Sponsor
• Sen. Mikulski, Barbara A. [D-MD] · D · Cosponsor
• Sen. Frist, William H. [R-TN] · R · Cosponsor
• Rep. Jeffords, James M. [R-VT-At Large] · R · Cosponsor
• Sen. Bond, Christopher S. [R-MO] · R · Cosponsor
• Susan Collins · R · Cosponsor
• Sen. Landrieu, Mary L. [D-LA] · D · Cosponsor
• Sen. Feinstein, Dianne [D-CA] · D · Cosponsor
• Sen. Corzine, Jon S. [D-NJ] · D · Cosponsor
• Rep. Carper, Thomas R. [D-DE-At Large] · D · Cosponsor
• Patty Murray · D · Cosponsor
• John Reed · D · Cosponsor
• Sen. Bingaman, Jeff [D-NM] · D · Cosponsor
• Rep. Roberts, Pat [R-KS-1] · R · Cosponsor
• · sshr00 · Standing

Related records

• related to → Best Pharmaceuticals for Children Act
• related to ← Best Pharmaceuticals for Children Act