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AccesstoInvestigationalDrugs.PDF
Access to Investigational Drugs
___________________________
Terry Toigo
Richard Klein
Office of Special Health Issues
Food and Drug Administration
Outline
? What is expanded access?
? 1997 FDA Modernization Act
? Expanded access programs – Benefits and Risks
? Implementing the process
– Who is responsible for what?
? Questions/Answer
2
For Patients Seeking Treatment…
? FDA-approved drugs should be the first option
? If patients do not respond to, or are intolerant of approved
therapy, investigational drugs may be available through two
potential pathways designed to help protect patients from
unknown potential risks to patients, where we do not know if a
drug is effective.
– Some may be eligible to receive an investigational drug as a
participant in a clinical trial.
– Some may pursue an expanded access program (EAP) also
known sometimes as “compassionate use.”
3
What is Expanded Access?
? Use of an investigational drug or biologic to treat a
patient with a serious disease or condition who does
not have comparable or satisfactory alternative
therapies to treat the disease or condition.
? Contrast with investigational drug in a clinical trial
where the primary intent is research (systematic
collection of data with the intent to analyze it to learn
about the drug)
4
1997 FDA Modernization Act
Amended § 561 of the FDC Act to say an individual patient may
obtain an investigational drug for treatment use when:
9 The patient’s physician determines that the patient has
no comparable or satisfactory alternative therapy;
9 FDA determines that there is sufficient evidence of
safety and effectiveness to support use of the
investigational dru
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