Regulations of Pharmaceutical Companies

The Food and Drug Administration (FDA) works to monitor firms producing, developing and marketing drugs in the U.S. marketplace. The goal of the FDA is to protect consumers from unsafe products by regulating development, inspection, recalls, injunctions and sampling within the industry. The FDA also regulates foreign products imported into the United States, which included more than 17 million lines of import entries in 2008.

Disqualifications and Restrictions of Clinical Investigators

• The FDA regulates the studies used to develop the effectiveness and safety of investigational drugs for humans and animals. All experts must comply with regulations set forth to ensure the integrity of data and approvals. The FDA can disqualify any experts who repeatedly fail to comply with requirements. The FDA can also disqualify anyone who submits false information to the sponsor or FDA. If the FDA disqualifies or restricts an expert, he cannot receive any drugs, devices or biologics.

Application Integrity Policy

• The FDA's Application Integrity Policy (AIP) deals with the integrity of applications submitted for agency approval and review. If the FDA suspects an application of providing misleading or false information, the FDA investigates the applicant through this policy. The policy is in effect to ensure a consistent application procedure and the importance of following up concerns with thorough investigations. The AIP cannot be invoked until a determination is made that there is an untrue statement on the application.

Foreign Clinical Studies

• The FDA permits foreign clinical studies for the applications of a biological product as long as it meets specific conditions. These conditions state the foreign studies must meet all requirements that also apply to U.S. studies. A foreign study must operate under the investigational device exemption or the investigational new drug application unless it receives special permission.