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U.S. Department of Health and Human Services

About FDA

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About the Office of Scientific Investigations

 The goals of the Office of Scientific Investigations (OSI) are to verify the integrity of efficacy and safety data submitted to the FDA in support of new drug applications and to assure that the rights and welfare of human research subjects are protected.

What OSI Does

OSI serves the American people by:

  • Auditing and verifying clinical trial data submitted to the FDA in support of applications to demonstrate the safety and efficacy, or bioequivalence, of drugs for human use;
  • Directing inspections of Institutional Review Boards for compliance with standards and regulations designed to protect the rights and welfare of human research subjects; and
  • Ensuring that investigators, sponsors, and contract research organizations who conduct nonclinical and clinical studies on investigational new drugs comply with United States laws and regulations covering good clinical practice and good laboratory practice.

 Brief History

In June 1938 President Roosevelt signed the Federal Food, Drug and Cosmetic Act into law. Among other things, this law required new drugs to be tested for safety before marketing, and the results submitted to FDA in a new drug application (NDA). The law also required that drugs have adequate labeling for safe use.

The U.S. Senate held hearings in June 1960 to strengthen the drug provisions of the 1938 Act. These hearings, chaired by Senator Estes Kefauver of the Subcommittee on Antitrust and Monopoly of the Committee on the Judiciary, resulted in S.3815. This bill aimed to protect the public health by instituting certain manufacturing practices, expanding antibiotic certification to all antibiotics, and by other measures.

During the Kefauver hearings, FDA received an NDA for Kevadon, the brand of thalidomide that the William Merrell Company hoped to market in the U.S. Despite ongoing pressure from the firm, medical officer Frances Kelsey refused to allow the NDA to become effective because of insufficient safety data. Even though Kevadon was never approved for marketing, Merrell had distributed over two million tablets for investigational use, which the law and regulations left mostly unchecked. By 1962 thalidomide's horrifying effects on newborns became known and the agency moved quickly to recover the supply from physicians, pharmacists, and patients. For her efforts, Kelsey received the President's Distinguished Federal Civilian Service Award in 1962, the highest civilian honor available to government employees.

As a result of the narrowly avoided tragedy in the U.S. from thalidomide, Senator Estes Kefauver re-introduced his bill. On October 10, 1962, President John F. Kennedy signed the Drug Amendments of 1962, also known as the Kefauver-Harris Amendments. These Amendments required drug manufacturers to prove to the FDA that their products were both safe and effective prior to marketing.

The Drug Amendments also addressed the use of drugs in clinical trials, including a requirement of informed consent by subjects. FDA had to be provided with full details of the clinical investigations, including drug distribution, and the clinical studies had to be based on previous animal investigations to assure safety.

In the wake of the new law, the Division of New Drugs was restructured in 1962. The Investigational Drug Branch, directed by Dr. Frances Kelsey, evaluated proposed clinical trials for compliance with investigational drug regulations.

In 1967 the Investigational Drug Branch was reorganized and the Division of Scientific Investigations was established.  OSI is now under the Office of Compliance, in the Center for Drug Evaluation and Research.

Additional details about CDER's history 

For more information about the Bioresearch Monitoring Program, see The History of FDA's Bioresearch Monitoring Program [PDF], Alan B. Lisook, M.D., CDER, 1991.

 

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