Final Rules for Expanded Access to Investigational Drugs for Treatment Use and Charging for Investigational Drugs
In August 2009 FDA amended its investigational new drug application (IND) regulation with two final rules:
- Expanded Access to Investigational Drugs for Treatment Use (PDF - 216KB)
- Charging for Investigational Drugs (PDF - 204KB)
FDA News Release (8/12/2009)
The final rule, “Expanded Access to Investigational Drugs for Treatment Use,” amends regulations on expanded access to investigational new drugs for treating patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use will be available to:
- individual patients, including in emergencies
- intermediate-size patient populations
- larger populations under a treatment protocol or treatment investigational new drug application (IND)
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. The rule goes into effect 60 days from date of publication in the Federal Register.
The final rule, “Charging for Investigational Drugs Under an Investigational New Drug Application,” amends the IND regulation on charging patients for investigational drugs. The rule revises the charging regulation to:
- clarify the circumstances under which charging for an investigational drug in a clinical trial is appropriate,
- set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in FDA's final rule on expanded access for treatment use of investigational drugs, and
- clarify what costs can be recovered.
The rule permits charging for a broader range of investigational and expanded access uses than is explicitly permitted in current regulations. The rule goes into effect 60 days after its publication in the Federal Register.
Information for Patients
- FDA Draft Guidance: Qs and As about Expanded Access to Investigational Drugs for Treatment Use (PDF - 75KB)
FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs[ARCHIVED]
FDA News Release (8/12/2009)
Proposed Rules: Charging for Investigational Drugs and Expanded Access to Investigational Drugs for Treatment Use Physician Request for an Individual Patient IND under Expanded Access for Non-emergency or Emergency Use Investigational New Drug (IND) Application Drug Development and Review Definitions Small Business Assistance: Frequently Asked Questions on Drug Development and Investigational New Drug Applications Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting Contact, Organization, and Meeting Information FDAAA Certification to Accompany Drug, Biological Product, and Device Applications or Submissions