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KMID : 0986720130210010007
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Korean Journal of Medicine and Law
2013 Volume.21 No. 1 p.7 ~ p.33
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Expanded Access Program Under Pharmaceutical Affairs Act
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Kang Han-Cheol
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Abstract
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The Expanded Access Program ("EAP") means the institution which was introduced under the Pharmaceutical Affairs Act ("PAA") in order to expand terminally-ill patients" access to investigational new drugs. The EAP consists of treatment purpose use approval program and medical emergency use approval program. In case a patient wants to gain access to investigational new drugs under the EAP, under the PAA, it is needed for an applicant to obtain the approval of the Korean Food and Drug Administration ("KFDA") by submitting required materials to the KFDA and requesting the KFDA to review the materials. It is notable that especially in the course of medical emergency use approval program, the applicant, mainly the physician in charge of the patient, is required to submit medical chart of the patient, brief summary of his/her medical opinion and diagnosis to the KFDA. Considering the nature of required documents, it is conceivable that the KFDA should be interpreted as having the power to scrutinize "medical propriety" of drug prescriptions produced by the physician. However, taking into consideration the Medical Service Act"s provision providing that only physicians are eligible to conduct medical practices and the importance of treatment"s timing, I believe that the scope of the KFDA"s scrutiny should be restricted to formality review of submitted documents and confirmation of statistical safety and efficacy of prescribed investigational new drugs. And the physician and a pharmaceutical company which is demanded to procure prescribed investigational new drugs are obliged to provide adequate explanation and consultation to the patient before the implementation of the EAP. If the KFDA refuses to approve the EAP without reasonable basis, the patient could be considered as having a legitimate and legal interest to seek the cancellation of the KFDA"s refusal through an administrative action process.
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KEYWORD
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Expanded Access Program, Clinical Trial, Off-Label Use, Investigation New Drugs, Pre-approval Drugs
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