Food and Drug Administration Revitalization Act explained

Shorttitle:	Food and Drug Administration Revitalization Act
Longtitle:	An Act to amend the Federal Food, Drug, and Cosmetic Act to revitalize the Food and Drug Administration, and for other purposes.
Nickname:	Food and Drug Administration Revitalization Act of 1990
Enacted By:	101st
Effective Date:	November 28, 1990
Public Law Url:	http://www.gpo.gov/fdsys/pkg/STATUTE-104/pdf/STATUTE-104-Pg4583.pdf
Cite Public Law:	101-635
Acts Amended:	Federal Food, Drug, and Cosmetic Act
Title Amended:	21 U.S.C.: Food and Drugs
Leghisturl:	http://thomas.loc.gov/cgi-bin/bdquery/z?d101:s.00845:
Introducedin:	Senate
Introducedby:	Orrin G. Hatch (R–UT)
Introduceddate:	April 19, 1989
Committees:	Committee on Labor and Human Resources and House Committee on Energy and Commerce
Passedbody1:	Senate
Passeddate1:	October 25, 1990
Passedvote1:	passed
Passedbody2:	House
Passeddate2:	October 27, 1990
Passedvote2:	agreed by voice vote
Signedpresident:	George H. W. Bush
Signeddate:	November 28, 1990

The Food and Drug Administration Revitalization Act was introduced by the 101st Congress of the United States. Senator Orrin G. Hatch was the chairperson sponsor of the federal revitalization amendment for the Food and Drug Administration.^[1]

The FDA revitalization was orchestrated by Commissioner of Food and Drugs Dr. David Kessler in pursuant of the congressional authorization permissible by 101st Senate bill 845;^{[2] [3] [4]}

Elements of Food and Drug Administration Revitalization

• Digital transformation and Information technology harmonizing FDA as information agency
• Enforcement programs streamlined by contingencies of FDA field activities^{[5] [6]}
• Establishment of Office of Criminal Investigations
• New drug approval process funding by prescription drug user fee^{[7] [8]}
• Progressive domestic and imports investigation programs by FDA^[9]
• Proposed rule for regulation of tobacco by U.S. FDA^{[10] [11]}
• Quality standards for mammography facilities endorsed by Mammography Quality Act
• Reduction in application review times for public healthcare products
• Safety information and adverse event reporting program ― MedWatch
• Standardization of nutrition facts label as authorized by Nutrition Labeling Act

The Title 21 amendment was signed into law on November 28, 1990, by the 43rd President of the United States George H. W. Bush.

Provisions of the Act

The Food and Drug Administration Revitalization Act of 1990 was penned with four legislative titles establishing a medium for the rejuvenation of the public health agency.

Title I: Administrative and Laboratory Facility Consolidation - 21 U.S.C. § 379b

General Services Administration provided authority to grant contracts for consolidated Food and Drug Administration facilities. The contracts shall be granted for the design, construction, and operation of consolidated Food and Drug Administration facilities.

Title II: Recovery and Retention of Fees for FOIA Requests - 21 U.S.C. § 379c

Charge fees shall be applied to recover reasonable costs incurred in processing Freedom of Information requests for records obtained or created under this Act.

Title III: Scientific Review Groups - 21 U.S.C. § 394

Technical and scientific review groups shall be established as needed to perform functions of the Food and Drug Administration.

Title IV: Automation of FDA - 21 U.S.C. § 379d

Agency shall automate appropriate activities of the Food and Drug Administration to ensure timely review of regulatory activities under this Act.

Observations of U.S. Government Accountability Office

• Web site: Food and Drug Administration: Insufficient Planning for Field Laboratory Consolidation Decisions . December 4, 1987 . U.S. GAO ~ HRD-88-21 . U.S. Government Accountability Office.
• Web site: FDA Resources: Comprehensive Assessment of Staffing, Facilities, and Equipment Needs . September 15, 1989 . U.S. GAO ~ HRD-89-142 . U.S. Government Accountability Office.
• Web site: FDA Laboratories: Magnitude of Benefits Associated With Consolidation Is Questionable . March 19, 1996 . U.S. GAO ~ HEHS-96-30 . U.S. Government Accountability Office . 34612714.
• Web site: Financial Management: FDA's Controls Over Property Have Improved, But Weaknesses Remain . February 22, 1999 . U.S. GAO ~ AIMD-99-51 . U.S. Government Accountability Office . 40986237.
• Web site: Food and Drug Administration: Status of Actions to Address Property Control Weaknesses . August 10, 1999 . U.S. GAO ~ AIMD-99-257R . U.S. Government Accountability Office . 42583474.

Supplementary Resources

• Remarks by the Deputy Commissioner of Food and Drugs . Benson . James S . January 1991 . Food, Drug, Cosmetic Law Journal . 46 . 1 . Food and Drug Law Institute . 26659272 . 27–29.
• State of the Food and Drug Administration . Benson . James S . July 1990 . Food, Drug, Cosmetic Law Journal . 45 . 3 . Food and Drug Law Institute . 26659048 . 301–317.
• Improving the Generic Drug Regulatory System . Benson . James S . May 1990 . Food, Drug, Cosmetic Law Journal . 45 . 3 . Food and Drug Law Institute . 26659239 . 207–217.
• Areas for Change in the Food and Drug Laws . Hatch . Orrin G . April 1983 . Food, Drug, Cosmetic Law Journal . 38 . 2 . Food and Drug Law Institute . 26658496 . 97–102.

External links

• Web site: The Federal Food Safety System: A Primer . December 16, 2016 . . Congressional Research Service.
• Web site: Proposed Reorganization of U.S. Federal Food Safety Agencies . September 7, 2018 . . Congressional Research Service.

Notes and References

1. The Future Direction of the Food and Drug Administration . Hatch . Orrin G . 1991 . Food, Drug, Cosmetic Law Journal . 46 . 1 . Food and Drug Law Institute . 26659270 . 15–20.
2. Remarks by the Commissioner of Food and Drugs . Kessler . David A . January 1991 . Food, Drug, Cosmetic Law Journal . 46 . 1 . Food and Drug Law Institute . 26659271 . 21–26.
3. Responding to the Challenge: A Revitalized FDA . Kessler, M.D. . David A . May 1991 . Food, Drug, Cosmetic Law Journal . 46 . 3 . Food and Drug Law Institute . 26659032 . 391–394.
4. Remarks by the Commissioner of Food and Drugs . Kessler, M.D. . David A . 1995 . Food and Drug Law Journal . 50 . 2 . Food and Drug Law Institute . 26659586 . 327–334.
5. The FDA's Philosophy of Enforcement . Hoeting . Alan L . 1991 . Food, Drug, Cosmetic Law Journal . 46 . 2 . Food and Drug Law Institute . 26659201 . 267–272.
6. The FDA's Enforcement Program . Hoeting . Alan L . 1992 . Food, Drug, Cosmetic Law Journal . 47 . 4 . Food and Drug Law Institute . 26659256 . 405–409.
7. Changes in Normal Drug Approval Process in Response to the AIDS Crisis . Cooper, M.D. . Ellen C . 1990 . Food, Drug, Cosmetic Law Journal . 45 . 4 . Food and Drug Law Institute . 26659051 . 329–338.
8. The Orphan Drug Regulations and Related Issues . Levitt . Joseph A . Kelsey . John V . 1993 . Food and Drug Law Journal . 48 . 4 . Food and Drug Law Institute . 26659374 . 525–532.
9. FDA Investigators and Investigations in the 1990s . Williams, Jr. . Troy E . 1992 . Food and Drug Law Journal . 47 . 3 . Food and Drug Law Institute . 26659216 . 279–286.
10. News: Scientists Say Cigarette Company Suppressed Findings on Nicotine . Hilts . Philip J . April 29, 1994 . The New York Times.
11. News: Cigarette Company Developed Tobacco With Stronger Nicotine; Head of F.D.A. Tells of Chemical Manipulation . Leary . Warren E . June 22, 1994 . The New York Times.