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U.S. Department of Health and Human Services

Drugs

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Notice to Industry: Postmarketing Requirements - Postmarket studies and clinical trials

FDA’s mission is to ensure that safe and effective new drugs are available as quickly as possible and that drugs already marketed remain safe and of the highest quality for as long as the drugs remain on the U.S. market.  As part of this authority, industry should be on notice that FDA intends to vigorously enforce requirements that sponsors conduct postmarket studies and clinical trials. 

In 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA), which amended the Food, Drug, and Cosmetic Act (the Act) to provide the agency with substantial new authorities to ensure the safe and appropriate use of drugs.  One of these provisions gives FDA the authority to require drug companies to conduct postmarketing studies or clinical trials – known as postmarketing requirements (PMRs).  FDA may require these PMRs either at the time of approval or after approval if the agency becomes aware of new safety information that could indicate a serious potential risk associated with the use of the drug (section 505(o)(3) of the Act). 

FDA may require postmarketing studies and clinical trials: 

  • To assess a known serious risk related to the use of the drug;
  • To assess signals of a serious risk related to the use of the drug; and
  • To identify an unexpected serious risk when available data indicate the potential for serious risk. 

Once FDA notifies a drug sponsor of the need for a postmarketing study or clinical trial, the company is required to provide a timetable for completion, including study milestones, and periodic status reports on progress toward completion of the PMRs.  If a company fails to comply with the timetable, FDA is authorized to take enforcement action against the company, unless the company can demonstrate good cause for the failures. 

FDA’s enforcement actions may include issuing a Warning Letter and assessing civil monetary penalties.  A company that violates postmarketing study requirements may be subject to civil monetary penalties of up to $250,000 per violation, with the possibility of additional monetary penalties if the violation continues uncorrected.  In addition, if a company violates postmarketing study requirements, its product may be deemed misbranded.   

Reflecting the agency’s commitment to enforce these statutory provisions, FDA intends to take enforcement action against companies that fail to conduct these required studies in a timely manner. 

Guidance for Industry:  Postmarketing Studies and Clinical Trials – Implementation of Section 505(o)(3)of the Federal Food, Drug, and Cosmetic Act (Drug Safety, April 2011) [PDF - 276KB]