Research Article| Volume 20, SUPPLEMENT 3, C86-C95, 1998

Regulation of prescription drug promotion: direct-to-consumer advertising

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      The US Food and Drug Administration (FDA) is responsible for regulating the information on prescription drugs disseminated by sponsors to health care providers and consumers to ensure that it is truthful and not misleading, and that it presents a fair balance of benefit and risk information. Thus the public health is both protected and promoted by the dissemination of honest, accurate information about regulated products. This paper discusses the regulatory requirements for promotional materials for prescription drugs and the standards used by the FDA to evaluate these materials. It also discusses the agency's views on direct-to-consumer advertising, the enforcement actions that are available to the FDA, the process used by the FDA to determine what action should be taken and when, and what remedies are available.


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      1. 21 U.S.C. § 352(n).

      2. 21 C.F.R. § 202.1(1)(2).

      3. 21 C.F.R. § 202.1(1)(1).

      4. 21 C.F.R. § 202.1(e)(2).

      5. 21 U.S.C. § 321(n).

      6. 21 C.F.R. § 202.1(j)(1).

      7. 21 C.F.R. § 314.81(b)(3).

      8. 21 C.F.R. § 202.1(j)(4).

      9. 21 C.F.R. § 201.1(e)(1).

      10. 62 FR 43171, August 12, 1997.

      11. 21 C.F.R. § 202.1(e)(1).