The Florida Senate

499.018  Applications for approval of investigational drugs.--

(1)  A person that applies for use of an investigational drug that does not have a Notice of Claimed Investigational Exemption for a New Drug on file with the federal Food and Drug Administration or that is otherwise unlawful in interstate commerce must, in accordance with ss. 499.001-499.081, submit in writing to the department for review by the technical panel the following, if applicable:

(a)  The best available descriptive name of the drug, including to the extent known the chemical name and structure of any substance composing the drug, and a description of how the drug is to be used and administered.

(b)  A full report, by the applicant, to justify the proposed use of the drug.

(c)  A complete list of the components of the drug.

(d)  A complete statement of the quantitative composition of the drug, including reasonable variations that can be expected during its use.

(e)  A description of the source and preparation of any substances used as components, including the name and address of each supplier or processor, other than the applicant, for each substance.

(f)  A statement of the methods, facilities, and controls used for manufacturing, processing, and packing the investigational drug in accordance with good manufacturing practices as provided in rules adopted by the department.

(g)  The specific nature of the investigation to be conducted, together with information to show the scope and detail of the planned clinical observations and the clinical laboratory tests to be made and reported.

(h)  The proposed protocols for each investigator.

(i)  Written assurance that an institutional review committee is responsible for initial and continuing review and approval of the proposed clinical study, if the phases of the clinical study are conducted by a person affiliated with a state institution that agrees to assume responsibility for the study.

(j)  A statement that the applicant will:

1.  Notify the department within 10 days after the initiation of the clinical study or studies, and within 10 days after the termination of the clinical study or studies, giving the reasons for such termination; and

2.  Submit reports at least annually on all studies.

(k)  A statement that the applicant will notify each subcontractor if the investigation is discontinued.

(l)  Complete justification of all charges to be made related to the clinical study or studies.

(m)  A statement that the applicant assures that clinical studies in humans will not be initiated sooner than 45 days after the date the department receives the application, the provisions of chapter 120 notwithstanding, and that such clinical studies will not be conducted if so requested by the department before the expiration of the 45 days.

(n)  Documentation that the drug has been submitted to the Food and Drug Administration of the United States Department of Health and Human Services and that the Food and Drug Administration did not allow the application to become effective 180 days after submission of the application, the provisions of chapter 120 notwithstanding. Documentation must include all material submitted to and received from the Food and Drug Administration.

(o)  A report of the scientific training and experience considered appropriate by the applicant to qualify himself or herself or the subcontractor as a suitable expert to investigate the safety and use of the drug. The report must include the names and addresses of all subcontractors.

(p)  A list of the names and a summary of the training and experience of each investigator and of the individual in charge of the use of the drug, and a statement from the applicant that he or she has obtained from each subcontractor a completed and signed form and a statement that the subcontractor is qualified by scientific training and experience as an appropriate expert.

(q)  An outline of all phases of the planned investigations that will include clinical pharmacology. Data available must show the method of determining human toxicity, metabolism, absorption, elimination, and other pharmacological action; the preferred route of administration; and the potential safe dosage range.

(r)  A statement covering all information available to the applicant derived from preclinical investigations and any clinical studies or experience with the drug, including adequate information about the investigations, studies made on laboratory animals, and the basis on which the applicant has concluded that it is reasonably safe to initiate or continue clinical investigations with the drug.

All information contained in the application for approval of an investigational drug is confidential and exempt from the provisions of s. 119.07(1).

(2)  In addition to the requirements of subsection (1), if the drug has been marketed commercially or investigated outside the United States, complete information regarding any distribution or investigation must be submitted, along with a complete bibliography of any publications about the drug, which information must include all informational material, including the label and labeling, which was supplied to each subcontractor to whom the applicant subcontracted the use of the drug. The information must include an accurate description of the prior investigations and experience and their results pertinent to the safety and possible usefulness of the drug under the conditions of the investigation and must include a description of all hazards, contraindications, side effects, and precautions suggested by prior investigations and experience with the drug under investigation and related drugs.

(3)  A manufacturer who is licensed under ss. 499.01 and 499.013 and who was licensed before July 1, 1984, under former s. 402.36 may continue to be licensed under ss. 499.001-499.081 and may have the product for which it was licensed under former s. 402.36 registered under this subsection if the manufacturer continues to meet the requirements imposed on it before July 1, 1984, through its agreement with the department and meets good manufacturing practices as established by rule. Protocols approved under former s. 402.36 may be continued, but other uses or protocols for use must be approved under paragraph (1)(h) and rules adopted under that paragraph.

(4)  The department may deny an application, or suspend or revoke an approved application, for an investigational drug for any violation of ss. 499.001-499.081 or the rules adopted under those sections or for a violation of the protocol approved by the department.

History.--s. 34, ch. 82-225; s. 112, ch. 83-218; s. 1, ch. 83-265; s. 4, ch. 84-115; ss. 5, 14, ch. 88-159; s. 4, ch. 89-296; ss. 21, 52, ch. 92-69; s. 331, ch. 96-406; s. 1155, ch. 97-103.