Food and Drug Administration Modernization Act of 1997

Summary

TABLE OF CONTENTS: Title I: Improving Patient Access Title II: Increasing Access to Expertise and Resources Title III: Improving Collaboration and Communication Title IV: Improving Certainty and Clarity of Rules Title V: Improving Accountability Title VI: Increasing Resources by Setting Priorities Title VII: Fees Relating to Drugs Title VIII: Miscellaneous Food and Drug Administration Modernization and Accountability Act of 1997 - Title I: Improving Patient Access - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth a Food and Drug Administration (FDA) mission statement. (Sec. 102) Authorizes any person, through a licensed practitioner, to request, and any manufacturer or distributor to provide, an investigational drug, biological product, or device for the diagnosis, monitoring, or treatment of a serious condition (or any other condition designated by the Secretary of Health and Human Services) if specified requirements are met. (Sec. 103) Modifies effectiveness exception requirements for devices relating to conditions that affect fewer than 4,000 individuals in the United States. Title II: Increasing Access to Expertise and Resources - Mandates programs and policies that foster collaboration between the FDA, the National Institutes of Health, and other science-based Federal agencies. (Sec. 202) Declares the sense of the Senate Labor and Human Resources Committee concerning international regulatory harmonization regarding drugs, biological products, devices, foods, food additives, color additives, and good manufacturing practices. (Sec. 203) Authorizes a contract with any organization or individual with relevant expertise to review, evaluate, and make recommendations on part or all of any application or submission regarding approval of a biological product. Mandates use of that authority when such a contract will improve a review's timeliness or quality. (Sec. 204) Mandates accreditation of non-governmental entities to review and make recommendations regarding submissions under provisions relating to reports preceding the introduction of devices into interstate commerce. (Sec. 205) Authorizes recognition of all or part of a performance standard established by a nationally or internationally recognized standard development organization for which a person may submit a conformity declaration. Title III: Improving Collaboration and Communication - Directs the Secretary: (1) on request of a person intending to submit a premarket approval application, to meet with the person to determine the type of scientific evidence of effectiveness that will be necessary; and (2) to meet with a premarket approval applicant to discuss the application's review status and, prior to that meeting, to notify the applicant in writing of application deficiencies. Title IV: Improving Certainty and Clarity of Rules - Mandates (after evaluation of the Good Guidance Practices document published in the Federal Register) promulgation as a regulation of FDA policies and procedures for the development, issuance, and use of guidance documents. (Sec. 402) Allows a person who submits an application or submission to submit a request regarding: (1) classification of the article as a drug, biological product, or device; or (2) the FDA component that will regulate the article. (Sec. 403) Allows, six years after application approval, use by the Secretary of application information in approving devices, determining whether product development protocols have been completed, establishing a performance standard or special control, and classifying devices. (Sec. 404) Requires, in determining premarket approval and substantial equivalence, reliance on the proposed labeling's use conditions. (Sec. 405) Defines "day" for provisions relating to review of any application or submission. (Sec. 406) Sets review time limits regarding initial classification and premarket approval. (Sec. 407) Prohibits withholding initial classification because of a failure to comply with any FDCA provision unrelated to a substantial equivalence decision, including a failure to comply with good manufacturing practice requirements. (Sec. 408) Mandates a regulation specifying the general principles considered in determining whether a specific intended device use is not reasonably included in a general use of the device for purposes of a substantial equivalence determination. (Sec. 409) Declares that device effectiveness is to be determined by well-controlled investigations, including one or more clinical investigations (currently, including clinical investigations). Allows the Secretary, if the Secretary determines that only one investigation is required for new drug approval, to require supporting scientific evidence obtained prior to or after the investigation. (Sec. 410) Repeals provisions prohibiting using, on any drug or device label, any suggestion of approval under FDCA new drug, premarket approval, or investigational use exemption provisions. Title V: Improving Accountability - Directs the Secretary to publish: (1) a plan bringing the Secretary into compliance with each of the Secretary's obligations under the FDCA and other statutes; and (2) an annual report on the Secretary's performance under the plan. Title VI: Increasing Resources by Setting Priorities - Mandates modification of specified Federal Regulations regarding the procedures and conditions under which a device may be granted an exemption from certain FDCA requirements. Requires the regulation to permit developmental device changes without requiring additional application approval in specified circumstances. Directs the Secretary (for premarket approval) to accept and review information from investigations conducted under the authority of regulations required by investigational exemption provisions. Requires a supplemental application for a change that affects a device's safety or effectiveness, subject to exception. Regulates review of supplemental applications. (Sec. 602) Declares that no action by the Secretary under the FDCA shall be subject to an environmental assessment or impact statement or other environmental consideration, subject to exception. (Sec. 603) Mandates publication of a list of each type of class II device that does not require a report prior to introduction into interstate commerce. Exempts those types from the reporting requirement. Provides for petitioning for exemption of a type. (Sec. 604) Modifies requirements regarding: (1) reporting prior to introduction into interstate commerce; and (2) initial classification and reclassification of certain devices. (Sec. 606) Empowers any patient receiving a device subject to tracking to refuse to release (or refuse permission to release) identifying information for tracking purposes. Mandates publication of a list identifying each type of device subject to tracking. Deems any device not identified exempt from mandatory tracking. (Sec. 607) Modifies postmarket surveillance requirements. (Sec. 608) Removes: (1) references to distributors in provisions relating to recordkeeping and reporting; and (2) a requirement that each manufacturer, importer, and distributor submit an annual certification. (Sec. 609) Mandates approval of a new drug application based on information from a small facility. (Sec. 610) Sets forth requirements regarding radiopharmaceuticals designed for diagnosis and monitoring of diseases and conditions. (Sec. 611) Amends the Public Health Service Act to revise requirements regarding: (1) introducing biological products into interstate commerce, including related license approval and labeling requirements; and (2) inspection of biological product facilities. (Sec. 612) Amends the FDCA to allow approval of a supplement to an approved application for an additional use of a drug based on literature, clinical experience, or scientific evidence. (Sec. 613) Requires that a health care economic statement included in labeling or advertising provided to a formulary committee, managed care organization, or similar entity with responsibility for drug selection be competent and reliable. Makes any such statement subject solely to this section. (Sec. 614) Directs the Secretary to facilitate development and expedite approval of new drugs and biological products intended for serious conditions and that demonstrate the potential to address unmet medical needs for those conditions. Terms such products "fast track drugs." Sets forth designation requirements and procedures. (Sec. 615) Regulates changes in the manufacture of a new drug or biological product. (Sec. 616) Mandates guidance that describes when abbreviated study reports in lieu of full reports may be submitted with a new drug application for certain types of studies. (Sec. 617) Deems a food contact substance (a substance used as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, but not intended to have any technical effect in the food) unsafe and the food adulterated unless: (1) there is (and the substance is in conformity with) a regulation prescribing the conditions under which the substance may be safely used; or (2) the manufacturer has notified the Secretary of the identity and intended use of the substance and the manufacturer's or supplier's determination that the substance is safe under a specified standard. (Sec. 618) Allows a health claim to be made regarding the relationship of a food to a disease or health-related condition if: (1) an authoritative scientific body of the U.S. Government with official responsibility for public health protection or research directly relating to human nutrition or the National Academy of Sciences has published statements, conclusions, or recommendations in effect recognizing that relationship; and (2) the manufacturer or distributor has notified the Secretary of the claim. (Sec. 619) Allows for additional deferred effective dates for the approval of certain new drug applications to allow for additional pediatric information developed by further studies. Mandates development, publication, and annual updating of a list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. Title VII: Fees Relating to Drugs - Prescription Drug Users Fee Reauthorization Act of 1997 - Amends provisions concerning fees relating to drugs to revise and add various definitions. (Sec. 704) Makes the fee (currently, 50 percent of the fee) for human drug applications or supplements due on submission. Mandates a refund of 75 (currently, 50) percent if the application or supplement is refused for filing. Exempts from the fee: (1) an application for a drug for a rare condition (orphan drug) or a supplement proposing a new indication for a rare condition; and (2) certain applications or supplements including an indication for use in pediatric populations. Allows fee refund if an application or supplement is withdrawn. Modifies requirements regarding: (1) the annual prescription drug establishment fee; (2) the prescription drug product fee; (3) fee amounts; (4) fee adjustments; (5) fee waiver or reduction; (6) assessment of fees; and (7) crediting and availability of fees (including authorizing appropriations). (Sec. 707) Terminates, on a specified date, the effectiveness of the amendments made by this title. Title VIII: Miscellaneous - Requires (currently, allows) a foreign establishment that manufactures, processes, etc., a drug or device to register with the Secretary. Authorizes cooperative agreements with foreign countries to ensure that means are available to determine whether drugs or devices from such an establishment shall be refused admission to the United States on the grounds specified in existing provisions. (Sec. 802) Replaces the requirement that prescription-only drugs bear the label phrase "Caution: Federal law prohibits dispensing without prescription" with a minimum requirement of a label designation "Rx only." Removes provisions requiring that certain substances be labeled "Warning--May be habit forming." (Sec. 803) Requires that any person seeking to export an imported article under provisions relating to the disposition of goods after a decree of condemnation establish that the article was intended for export at the time the article entered commerce. (Sec. 804) Authorizes, directly or through grants, contracts, or cooperative agreements, the conduct and support of research training in regulatory scientific programs by predoctoral and postdoctoral scientists and physicians, including the use of fellowships. Authorizes the support of fellowships through a Cooperative Research and Development Agreement. (Sec. 805) Deems a device that is, or purports to be, subject to a performance standard or special control: (1) adulterated unless it conforms to the standard or special control; or (2) misbranded unless it bears labeling as prescribed in the standard or special control. (Sec. 806) Empowers the Secretary to require the submission of samples and component samples of a device: (1) in connection with a recall; and (2) if the device may have caused or contributed to a serious injury. (Sec. 807) Modifies the FDCA definition of "interstate commerce" to include any article or class of articles that directly or indirectly affects interstate commerce. Provides for the condemnation of any adulterated or misbranded device, food, drug, or cosmetic (currently, any adulterated or misbranded device). Presumes the existence of a connection with interstate commerce in any action to enforce FDCA requirements regarding a device, food, drug, or cosmetic (currently, regarding a device).

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

Timeline

1. 5 June 1997

   Introduced

   Read twice and referred to the Committee on Labor and Human Resources.

   Source: IntroReferral

2. 5 June 1997

   Introduced

   Sponsor introductory remarks on measure. (CR S5342-5343)

   Source: IntroReferral

3. 5 June 1997

   Introduced

   Introduced in Senate

   Source: IntroReferral

4. 11 June 1997

   Committee

   Committee on Labor and Human Resources. Committee consideration held.

   Source: Committee

5. 18 June 1997

   Reported

   Committee on Labor and Human Resources. Ordered to be reported with an amendment in the nature of a substitute favorably.

   Source: Committee

6. 1 July 1997

   Floor

   An errata sheet on written report No. 105-43 was printed.

   Source: Floor

7. 1 July 1997

   Calendars

   Placed on Senate Legislative Calendar under General Orders. Calendar No. 105.

   Source: Calendars

8. 1 July 1997

   Reported

   Committee on Labor and Human Resources. Reported to Senate by Senator Jeffords under the authority of the order of Jun 27, 97 with an amendment in the nature of a substitute. With written report No. 105-43. Additional and minority views filed.

   Source: Committee

9. 1 July 1997

   Reported

   Committee on Labor and Human Resources. Reported to Senate by Senator Jeffords under the authority of the order of Jun 27, 97 with an amendment in the nature of a substitute. With written report No. 105-43. Additional and minority views filed.

   Source: Committee

10. 28 July 1997

    Introduced

    Sponsor introductory remarks on measure. (CR S8162-8164)

    Source: IntroReferral

11. 3 September 1997

    Floor

    Motion to proceed to consideration of measure made in Senate. (consideration: CR S8720)

    Source: Floor

12. 4 September 1997

    Floor

    Motion to proceed to consideration of measure made in Senate. (consideration: CR S8821)

    Source: Floor

13. 5 September 1997

    Vote

    First cloture on the motion to proceed to consideration of measure invoked in Senate by Yea-Nay Vote. 89-5. Record Vote No: 220. (consideration: CR S8839-8840)

    Source: Floor

14. 8 September 1997

    Floor

    Motion to proceed considered in Senate. (consideration: CR S8878-8898)

    Source: Floor

15. 11 September 1997

    Passed

    Motion to proceed to consideration of measure agreed to in Senate by Unanimous Consent.

    Source: Floor

16. 16 September 1997

    Floor

    Measure laid before Senate by unanimous consent. (consideration: CR S9360-9363, S9375-9376, S9378-9385)

    Source: Floor

17. 18 September 1997

    Floor

    Considered by Senate. (consideration: CR S9632, S9694-9697)

    Source: Floor

18. 19 September 1997

    Floor

    Considered by Senate. (consideration: CR S9701-9713)

    Source: Floor

19. 23 September 1997

    Floor

    Considered by Senate. (consideration: CR S9737-9769, S9771-9775, S9781)

    Source: Floor

20. 24 September 1997

    Floor

    Considered by Senate. (consideration: CR S9811-9868)

    Source: Floor

21. 24 September 1997

    Vote

    Passed/agreed to in Senate: Passed Senate with an amendment by Yea-Nay Vote. 98-2. Record Vote No: 256.

    Source: Floor

22. 25 September 1997

    Floor

    Held at the desk.

    Source: Floor

23. 25 September 1997

    Floor

    Message on Senate action sent to the House.

    Source: Floor

24. 25 September 1997

    Floor

    Received in the House.

    Source: Floor

25. 7 October 1997

    Floor

    A similar measure H.R. 1411 was laid on the table without objection.

    Source: Floor

26. 7 October 1997

    Passed

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

    Source: Floor

27. 7 October 1997

    Passed

    The title of the measure was amended to that of similar measure H.R. 1411. Agreed to without objection.

    Source: Floor

28. 7 October 1997

    Passed

    On passage Passed without objection.

    Source: Floor

29. 7 October 1997

    Passed

    Passed/agreed to in House: On passage Passed without objection.

    Source: Floor

30. 7 October 1997

    Passed

    The House struck all after the enacting clause and inserted in lieu thereof the provisions of a similar measure H.R. 1411. Agreed to without objection.

    Source: Floor

31. 7 October 1997

    Floor

    Considered by unanimous consent. (consideration: CR H8482-8500)

    Source: Floor

32. 7 October 1997

    Floor

    Mr. Bliley asked unanimous consent to take from the Speaker's table and consider.

    Source: Floor

33. 22 October 1997

    Passed

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

    Source: ResolvingDifferences

34. 22 October 1997

    ResolvingDifferences

    The Speaker appointed conferees: Bliley, Bilirakis, Barton, Greenwood, Burr, Whitfield, Dingell, Brown (OH), Waxman, and Klink.

    Source: ResolvingDifferences

35. 22 October 1997

    Passed

    On motion that the House insist upon its amendments, and request a conference Agreed to without objection. (consideration: CR H8978)

    Source: ResolvingDifferences

36. 22 October 1997

    ResolvingDifferences

    Mr. Bliley asked unanimous consent that the House insist upon its amendments, and request a conference.

    Source: ResolvingDifferences

37. 23 October 1997

    Passed

    Senate agreed to request for conference. Appointed conferees. Jeffords; Coats; Gregg; Frist; Dewine; Kennedy; Dodd; Harkin; Mikulski. (consideration: CR S11018)

    Source: ResolvingDifferences

38. 23 October 1997

    Passed

    Resolving differences -- Senate actions: Senate disagreed to House amendments by Unanimous Consent.

    Source: NotUsed

39. 23 October 1997

    Floor

    Message on House action received in Senate and at desk: House amendments to Senate bill and House requests a conference.

    Source: Floor

40. 24 October 1997

    Floor

    Message on Senate action sent to the House.

    Source: Floor

41. 5 November 1997

    ResolvingDifferences

    Conference held.

    Source: ResolvingDifferences

42. 5 November 1997

    ResolvingDifferences

    Conference committee actions: Conference held.

    Source: ResolvingDifferences

43. 9 November 1997

    Passed

    On motion to suspend the rules and agree to the conference report Agreed to by voice vote. (consideration: CR H10531-10539)

    Source: ResolvingDifferences

44. 9 November 1997

    Passed

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

    Source: ResolvingDifferences

45. 9 November 1997

    Passed

    Conference report agreed to in House: On motion to suspend the rules and agree to the conference report Agreed to by voice vote.(consideration: CR H10531-10539)

    Source: ResolvingDifferences

46. 9 November 1997

    Floor

    DEBATE - The House proceeded with forty minutes of debate.

    Source: Floor

47. 9 November 1997

    ResolvingDifferences

    Mr. Bliley moved to suspend the rules and agree to the conference report, H. Rept. 105-399.

    Source: ResolvingDifferences

48. 9 November 1997

    Floor

    Message on Senate action sent to the House.

    Source: Floor

49. 9 November 1997

    Passed

    Conference report agreed to in Senate: Senate agreed to conference report by Voice Vote.(consideration: CR S12251)

    Source: ResolvingDifferences

50. 9 November 1997

    ResolvingDifferences

    Conference report H. Rept. 105-399 filed. (text of conference report: CR H10452-10478)

    Source: ResolvingDifferences

51. 9 November 1997

    ResolvingDifferences

    Conference report filed: Conference report H. Rept. 105-399 filed.(text of conference report: CR H10452-10478)

    Source: ResolvingDifferences

52. 9 November 1997

    Passed

    Conferees agreed to file conference report.

    Source: ResolvingDifferences

53. 9 November 1997

    Passed

    Conference committee actions: Conferees agreed to file conference report.

    Source: ResolvingDifferences

54. 19 November 1997

    Floor

    Presented to President.

    Source: Floor

55. 19 November 1997

    President

    Presented to President.

    Source: President

56. 21 November 1997

    Became law

    Became Public Law No: 105-115.

    Source: President

57. 21 November 1997

    Became law

    Signed by President.

    Source: BecameLaw

58. 21 November 1997

    President

    Signed by President.

    Source: President

Votes

Versions

• Enrolled Bill · undated · Official file
• Public Law · 21 November 1997 · Official file
• Engrossed Amendment House · 7 October 1997 · Official file
• Engrossed in Senate · 24 September 1997 · Official file
• Reported to Senate · 1 July 1997 · Official file
• Introduced in Senate · 5 June 1997 · Official file

Documents

17 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 · 21 November 1997

  ViewDownloadOpen at official source

• Public Law (PDF)

  Public Law · EN · 21 November 1997

  ViewDownloadOpen at official source

• Conference report filed in House

  summary · EN · 9 November 1997

  Open at official source

• Engrossed Amendment House (text)

  Engrossed Amendment House · EN · 7 October 1997

  ViewDownloadOpen at official source

• Engrossed Amendment House (PDF)

  Engrossed Amendment House · EN · 7 October 1997

  ViewDownloadOpen at official source

• Passed House amended

  summary · EN · 7 October 1997

  Open at official source

• Engrossed in Senate (text)

  Engrossed in Senate · EN · 24 September 1997

  ViewDownloadOpen at official source

• Engrossed in Senate (PDF)

  Engrossed in Senate · EN · 24 September 1997

  ViewDownloadOpen at official source

• Passed Senate amended

  summary · EN · 24 September 1997

  Open at official source

• Reported to Senate (text)

  Reported to Senate · EN · 1 July 1997

  ViewDownloadOpen at official source

• Reported to Senate (PDF)

  Reported to Senate · EN · 1 July 1997

  ViewDownloadOpen at official source

• Reported to Senate with amendment(s)

  summary · EN · 1 July 1997

  Open at official source

• Introduced in Senate (text)

  Introduced in Senate · EN · 5 June 1997

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 5 June 1997

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 5 June 1997

  Open at official source

Sponsors

• Rep. Jeffords, James M. [R-VT-At Large] · R · Sponsor
• Rep. Dodd, Christopher J. [D-CT-2] · D · Cosponsor
• Sen. Coats, Daniel [R-IN] · R · Cosponsor
• Sen. Mikulski, Barbara A. [D-MD] · D · Cosponsor
• Sen. Frist, William H. [R-TN] · R · Cosponsor
• Sen. Hagel, Chuck [R-NE] · R · Cosponsor
• Sen. Mack, Connie, III [R-FL] · R · Cosponsor
• Sen. Abraham, Spencer [R-MI] · R · Cosponsor
• · sshr00 · Standing

Related records

• related to → Food and Drug Administration Regulatory Modernization Act of 1997
• related to → To correct the enrollment of the bill S. 830.
• related to → A concurrent resolution to correct the enrollment of the bill S. 830.