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U.S. Department of Health and Human Services

Drugs

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Proposed Rules: Charging for Investigational Drugs and Expanded Access to Investigational Drugs for Treatment Use

FDA is proposing to amend its investigational new drug application (IND) regulation with two proposed rules:

The “Expanded Access to Investigational Drugs for Treatment Use, Proposed Rule” recommends amending regulations on access to investigational new drugs for the treatment of patients. It would clarify existing regulations and add new types of expanded access for treatment use. Under the proposal, expanded access to investigational drugs for treatment use would be available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application. It is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions, who lack other therapeutic options and who may benefit from such therapies. There is a 90-day public comment period provided in this propose rule.

The “Charging for Investigational Drugs, Proposed Rule” is proposing to amend the investigational new drug application regulation concerning charging patients for investigational new drugs. We are proposing to revise the current charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency’s proposed rule on expanded access for treatment use of investigational drugs, and to clarify what costs can be recovered for an investigational drug. It is intended to permit charging for a broader range of investigational and expanded access uses than is explicitly permitted in current regulations. There is a 90-day public comment period provided in this proposed rule.