Obtaining access to unlicensed drugs. CANADA SAP authorization does not constitute an opinion or statement that a drug is safe, efficacious or of high quality. SAP does not conduct a comprehensive evaluation to ensure the validity of drug information or attestations of the manufacturer respecting safety, efficacy and quality. These are important factors for practitioners to consider when recommending the use of a drug and in making an appropriate risk/benefit decision in the best interests of the patient. SAP strongly encourages practitioners treating patients with drugs obtained through SAP to seek informed consent prior to treatment. To initiate a request a practitioner may write, telephone, fax or e-mail the Special Access Programme: Special Access Programme (613) 941-2108 (08:30-16:30 hours EST) (613) 941-3061 (after-hours) Calls to this emergency service should be limited to requests for drugs or blood products requiring immediate or overnight drug delivery. Main Health Canada Website Special Access Program (SAP) web site UNITED STATES Introduction The acronym "IND" refers to an Investigational New Drug application, which is an application to the Food and Drug Administration (FDA) to administer an investigational new drug or biologic product to humans. Since a biologic is also considered a drug, the term "drug" as used in this document refers to either a drug or a biologic product. Most human use of investigational drugs takes place in clinical trials conducted to assess safety and efficacy of those drugs. Consequently, FDA's IND processes are designed primarily for drug companies and medical researchers engaged in clinical development of new drugs. However, some patients not eligible to participate in a clinical trial may benefit from treatment with an investigational drug under study. For such cases, FDA has developed numerous regulatory mechanisms to make investigational drugs available outside of clinical trials. These mechanisms include single-patient INDS, emergency INDS, and treatment INDs/protocols. Single-Patient INDs and Emergency INDs a) The patient must be informed about the drug and consent to be treated with it. b) The physician must be properly licensed and must agree to administer the product and be responsible for monitoring and reporting to FDA on the patient's use of the product (See forms 1571 and 1572. c) The local Institutional Review Board (IRB) must approve the proposed use of the investigational drug (please note that in emergency situations it may be possible for the physician to notify the IRB promptly after treating the patient), d) The manufacturer must be willing to provide the product without charge (unless the sponsor has applied for and FDA has allowed charges for cost recovery as provided for under Federal Regulations), and e) FDA has allowed the transfer of the product from the manufacturer to the physician. All Biological IND submissions must be made in triplicate and should be addressed as follows: Center for Biologics Evaluation and ResearchHFM-99, Room 200N 1401 Rockville Pike Rockville, MD 20852-1448 Phone: 800-835-4709 or 301-827-1800 Additional information and and all forms may be obtained at the FDA's Center for Biologics Evaluation and Research (CBER) web site Investigational New Drug Application process UNITED KINGDOM The conditions are that there is a bona fide unsolicited order, the product is formulated in accordance with the requirement of a doctor or dentist registered in the UK, and the product is for use by their individual patients on their direct personal responsibility. If a "special" is manufactured in the UK, the manufacturer must hold a manufacturer's (specials) licence issued by the MCA. A "special" may not be advertised and may not be supplied if an equivalent licensed product is available which could meet the patient's needs. Essential records must be kept and serious adverse drug reactions reported to the MCA. Contact for further information Inspection and Enforcement Division Telephone: 020-7273 0573 Medicines Control Agency main web site For specific information about "specials" Click on "Our work" on the left, then click "Licensing of Medicines" on the right. Scroll down and click on "Exemptions from licensing" AUSTRALIA
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