Food and Drug Administration Revitalization Act

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]

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 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, IND, and NDA review times for healthcare products^{[13][14][15][16]}
• Safety information and adverse event reporting program ― MedWatch^[17]
• Standardization of nutrition facts label as authorized by Nutrition Labeling Act

The Title 21 amendment was signed into law on November 28, 1990, by President 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.