Food and Drug Administration Safety and Innovation Act

Summary

Food and Drug Administration Safety and Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revises requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. Prescription Drug User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect prescription drug fees to support the FDA drug development and human drug application review process. Medical Device User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary to assess and use fees for expediting the review process for medical device applications and for assuring the safety and effectiveness of such devices. Generic Drug User Fee Amendments of 2012 - Directs the Secretary to assess and collect human generic drug user fees through FY2017, including a fee for drug applications pending on October 1, 2012, a drug master file fee, a generic drug facility fee, and an active pharmaceutical ingredient facility fee. Biosimilar User Fee Act of 2012 - Establishes a new program to assess and use fees to expedite the review process for biosimilar biological product applications. Makes permanent programs to study and provide extended exclusivity periods for new drugs for use in pediatric populations. Permits the FDA to change a classification of a medical device through an administrative order rather than by regulation. Expands reporting requirements for manufacturers of prescription drugs. Provides incentives for the development of new qualified infectious disease products, including: (1) an additional five-year market exclusivity period, and (2) eligibility for priority and fast track review. Requires the Secretary to: (1) expedite the development and review of new drugs designed to treat a serious or life-threatening disease, and (2) include a risk-benefit analysis in the regulatory decision-making process for prescription drugs. Amends the Orphan Drug Act to extend through FY2017 the authorization of appropriations for grants and contracts for development of drugs for rare diseases and conditions. Revises requirements for the reporting by drug manufacturers to HHS of a discontinuance or interruption in the production of life saving drugs. Requires the Secretary to establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages. Extends until October 1, 2017, the deadline for applications for elections relating to marketing exclusivity for certain drugs containing single enantiomers. Extends through FY2017 the authorization of appropriations for Critical Path Public-Private Partnerships to implement the FDA's Critical Path Initiative. Provides for the regulation of medical gas products. Directs the Secretary to: (1) issue guidance explaining FDA policy for promoting FDA-regulated medical products using the Internet and social media; (2) report to Congress on initiatives to combat prescription drug abuse; (3) reconsider tanning bed labeling requirements; (4) submit an integrated management strategy identifying goals for the FDA Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health; and (5) develop and implement strategies to solicit patient participation in the medical product development process.

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

Timeline

1. 15 May 2012

   Introduced

   Introduced in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.

   Source: Calendars

2. 15 May 2012

   Introduced

   Introduced in Senate

   Source: IntroReferral

3. 16 May 2012

   Calendars

   Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 400.

   Source: Calendars

4. 17 May 2012

   Floor

   Motion to proceed to consideration of measure made in Senate. (consideration: CR S3243-3248, S3252-3271)

   Source: Floor

5. 21 May 2012

   Floor

   Motion to proceed to consideration of measure made in Senate. (consideration: CR S3295-3307)

   Source: Floor

6. 22 May 2012

   Floor

   Motion to proceed to consideration of measure made in Senate. (consideration: CR S3389-3400, S3400-3420)

   Source: Floor

7. 23 May 2012

   Floor

   Motion to proceed to consideration of measure made in Senate. (consideration: CR S3459-3479)

   Source: Floor

8. 24 May 2012

   Floor

   Considered by Senate. (consideration: CR S3536-3609)

   Source: Floor

9. 24 May 2012

   Vote

   Passed/agreed to in Senate: Passed Senate with amendments by Yea-Nay Vote. 96 - 1. Record Vote Number: 111.(text: CR S3568-3608)

   Source: Floor

10. 25 May 2012

    Floor

    Held at the desk.

    Source: Floor

11. 25 May 2012

    Floor

    Received in the House.

    Source: Floor

12. 20 June 2012

    Floor

    Mr. Upton moved to suspend the rules and pass the bill, as amended.

    Source: Floor

13. 20 June 2012

    Floor

    Message on House action received in Senate and at desk: House amendment to Senate bill.

    Source: Floor

14. 20 June 2012

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: Floor

15. 20 June 2012

    Passed

    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H3825-3861)

    Source: Floor

16. 20 June 2012

    Passed

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H3825-3861)

    Source: Floor

17. 20 June 2012

    Floor

    DEBATE - The House proceeded with forty minutes of debate on S. 3187.

    Source: Floor

18. 20 June 2012

    Floor

    Considered under suspension of the rules. (consideration: CR H3825-3868)

    Source: Floor

19. 21 June 2012

    Floor

    Measure laid before Senate by unanimous consent. (consideration: CR S4409-4410)

    Source: Floor

20. 25 June 2012

    Vote

    Cloture on the motion to concur in the House amendment invoked in Senate by Yea-Nay Vote. 89 - 3. Record Vote Number: 166. (consideration: CR S4449; text: CR S4449)

    Source: Floor

21. 26 June 2012

    Vote

    Senate agreed to House amendment to the bill (S. 3187) by Yea-Nay Vote. 92 - 4. Record Vote Number: 168. (consideration: CR S4626)

    Source: ResolvingDifferences

22. 26 June 2012

    Vote

    Resolving differences -- Senate actions: Senate agreed to House amendment to the bill (S. 3187) by Yea-Nay Vote. 92 - 4. Record Vote Number: 168.(consideration: CR S4626)

    Source: NotUsed

23. 26 June 2012

    Floor

    Considered by Senate. (consideration: CR S4602-4606, S4610-4627)

    Source: Floor

24. 27 June 2012

    Floor

    Message on Senate action sent to the House.

    Source: Floor

25. 28 June 2012

    Floor

    Presented to President.

    Source: Floor

26. 28 June 2012

    President

    Presented to President.

    Source: President

27. 9 July 2012

    Became law

    Became Public Law No: 112-144.

    Source: President

28. 9 July 2012

    Became law

    Signed by President.

    Source: BecameLaw

29. 9 July 2012

    President

    Signed by President.

    Source: President

Votes

Versions

• Enrolled Bill · undated · Official file
• Public Law · 9 July 2012 · Official file
• Engrossed Amendment House · 20 June 2012 · Official file
• Engrossed in Senate · 24 May 2012 · Official file
• Placed on Calendar Senate · 16 May 2012 · Official file

Documents

12 official files

• Enrolled Bill (text)

  Enrolled Bill · EN

  ViewDownloadOpen at official source

• Enrolled Bill (PDF)

  Enrolled Bill · EN

  ViewDownloadOpen at official source

• Public Law (text)

  Public Law · EN · 9 July 2012

  ViewDownloadOpen at official source

• Public Law (PDF)

  Public Law · EN · 9 July 2012

  ViewDownloadOpen at official source

• Public Law

  summary · EN · 9 July 2012

  Open at official source

• Engrossed Amendment House (text)

  Engrossed Amendment House · EN · 20 June 2012

  ViewDownloadOpen at official source

• Engrossed Amendment House (PDF)

  Engrossed Amendment House · EN · 20 June 2012

  ViewDownloadOpen at official source

• Engrossed in Senate (text)

  Engrossed in Senate · EN · 24 May 2012

  ViewDownloadOpen at official source

• Engrossed in Senate (PDF)

  Engrossed in Senate · EN · 24 May 2012

  ViewDownloadOpen at official source

• Placed on Calendar Senate (text)

  Placed on Calendar Senate · EN · 16 May 2012

  ViewDownloadOpen at official source

• Placed on Calendar Senate (PDF)

  Placed on Calendar Senate · EN · 16 May 2012

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 15 May 2012

  Open at official source

Sponsors

• Rep. Harkin, Tom [D-IA-5] · D · Sponsor
• Sen. Enzi, Michael B. [R-WY] · R · Sponsor

Related records

• related to → Generic Drug and Biosimilar User Fee Act of 2012
• related to → Prescription Drug Labeling Promotion Act of 2012
• related to → To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.
• related to → Food and Drug Administration Reform Act of 2012
• related to → Advancing Breakthrough Therapies for Patients Act of 2012
• related to → Better Pharmaceuticals and Devices for Children Act of 2012
• related to → Food and Drug Administration Safety and Innovation Act