Restrictions on Distribution of Use of Prescription Drugs: Current Practices and Future Prospects

Abstract

FDA must continually balance its dual missions of protecting the public from unsafe and ineffective drugs and expeditiously allowing access to new and beneficial medications. While most risks associated with approved drugs are addressed by appropriate labeling, in the case of certain drugs this approach appears insufficient to ensure an appropriate risk-benefit profile. To avoid the stark choice between permitting a drug with significant risks to remain freely available for prescription and withdrawing the drug from the market, thereby depriving those who would benefit from it, FDA has sought an alternative approach. Under this alternative approach, FDA allows certain drugs to be marketed subject to restrictions on distribution or use. The Clozaril Risk Management Program and the issuance of the Subpart H regulations, both in the early 1990s, heralded the emergence of this more nuanced framework for managing the risks of prescription drug products. This paper describes and compares risk management programs of the ten drugs currently marketed with restrictions on distribution or use, discusses the circumstances under which the rism management programs were adopted, and situates these programs within the broader context of FDA’s evolving attitude towards risk management.