Food and Drug Administration Revitalization Act

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Food and Drug Administration Revitalization Act
Great Seal of the United States
Long titleAn Act to amend the Federal Food, Drug, and Cosmetic Act to revitalize the Food and Drug Administration, and for other purposes.
NicknamesFood and Drug Administration Revitalization Act of 1990
Enacted bythe 101st United States Congress
EffectiveNovember 28, 1990
Citations
Public law101-635
Statutes at Large104 Stat. 4583
Codification
Acts amendedFederal Food, Drug, and Cosmetic Act
Titles amended21 U.S.C.: Food and Drugs
U.S.C. sections amended
Legislative history

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]

☆ 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][12]
☆ 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.

References

  1. ^ Hatch, Orrin G (1991). "The Future Direction of the Food and Drug Administration". Food, Drug, Cosmetic Law Journal. 46 (1). Food and Drug Law Institute: 15–20. JSTOR 26659270.
  2. ^ Kessler, David A (January 1991). "Remarks by the Commissioner of Food and Drugs". Food, Drug, Cosmetic Law Journal. 46 (1). Food and Drug Law Institute: 21–26. JSTOR 26659271.
  3. ^ Kessler, M.D., David A (May 1991). "Responding to the Challenge: A Revitalized FDA". Food, Drug, Cosmetic Law Journal. 46 (3). Food and Drug Law Institute: 391–394. JSTOR 26659032.
  4. ^ Kessler, M.D., David A (1995). "Remarks by the Commissioner of Food and Drugs". Food and Drug Law Journal. 50 (2). Food and Drug Law Institute: 327–334. JSTOR 26659586.
  5. ^ Hoeting, Alan L (1991). "The FDA's Philosophy of Enforcement". Food, Drug, Cosmetic Law Journal. 46 (2). Food and Drug Law Institute: 267–272. JSTOR 26659201.
  6. ^ Hoeting, Alan L (1992). "The FDA's Enforcement Program". Food, Drug, Cosmetic Law Journal. 47 (4). Food and Drug Law Institute: 405–409. JSTOR 26659256.
  7. ^ Cooper, M.D., Ellen C (1990). "Changes in Normal Drug Approval Process in Response to the AIDS Crisis". Food, Drug, Cosmetic Law Journal. 45 (4). Food and Drug Law Institute: 329–338. JSTOR 26659051.
  8. ^ Levitt, Joseph A; Kelsey, John V (1993). "The Orphan Drug Regulations and Related Issues". Food and Drug Law Journal. 48 (4). Food and Drug Law Institute: 525–532. JSTOR 26659374.
  9. ^ Williams, Jr., Troy E (1992). "FDA Investigators and Investigations in the 1990s". Food and Drug Law Journal. 47 (3). Food and Drug Law Institute: 279–286. JSTOR 26659216.
  10. ^ 60 FR 41314
  11. ^ Hilts, Philip J (April 29, 1994). "Scientists Say Cigarette Company Suppressed Findings on Nicotine". The New York Times.
  12. ^ Leary, Warren E (June 22, 1994). "Cigarette Company Developed Tobacco With Stronger Nicotine; Head of F.D.A. Tells of Chemical Manipulation". The New York Times.

Observations of U.S. Government Accountability Office

Supplementary Resources

External links

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