Food and Drug Administration Revitalization Act

Food and Drug Administration Revitalization Act
Long title	An Act to amend the Federal Food, Drug, and Cosmetic Act to revitalize the Food and Drug Administration, and for other purposes.
Nicknames	Food and Drug Administration Revitalization Act of 1990
Enacted by	the 101st United States Congress
Effective	November 28, 1990
Citations
Public law	101-635
Statutes at Large	104 Stat. 4583
Codification
Acts amended	Federal Food, Drug, and Cosmetic Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections amended	21 U.S.C. ch. 9 § 301 et seq.; 21 U.S.C. ch. 9, subch. VII §§ 379b, 379c, 379d; 21 U.S.C. ch. 9, subch. X § 394;
Legislative history
	Introduced in the Senate as S. 845 by Orrin G. Hatch (R–UT) on April 19, 1989; Committee consideration by Committee on Labor and Human Resources and House Committee on Energy and Commerce; Passed the Senate on October 25, 1990 (passed); Passed the House on October 27, 1990 (agreed by voice vote); Signed into law by President George H. W. Bush on 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]^[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

^ 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.
^ 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.
^ 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.
^ 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.
^ 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.
^ 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.
^ 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.
^ 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.
^ 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.
^ 60 FR 41314
^ Hilts, Philip J (April 29, 1994). "Scientists Say Cigarette Company Suppressed Findings on Nicotine". The New York Times.
^ 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

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

Supplementary Resources

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

External links

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

[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.

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