76
STAT.]
PUBLIC LAW 87-781-OCT. 10, 1962
787
there is a lack of substantial evidence (as defined in section 505(d)) that the drug has the effect it purports or is represented to have under such conditions of use." RECORDS AND REPORTS AS TO E X P E R I E N C E ON A N T I B I O T I C S
SEC. 106. (a) Section 507 of such Act (21 U.S.C. 357) is amended 59 Stat. 463. by adding at the end thereof the following new subsection: " (g)(1) Every person engaged in manufacturing, compounding, or processing any drug within the purview of this section with respect to which a certificate or release has been issued pursuant to this section shall establish and maintain such records, and make such reports to the Secretary, of data relating to clinical experience and other data or information, received or otherwise obtained by such person with respect to such drug, as the Secretary may by general regulation, or by , ^ order with respect to such certification or release, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to make, or to facilitate, a determination as to whether such certification or release should be rescinded or whether any regulation issued under this section should be amended or repealed: Provided, however, That regulations and orders issued under this subsection and under clause (3) of subsection (d) shall 1 have due regard for the professional ethics of the medical profession and the interests of patients and shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulations or orders are applicable, of similar information received or otherwise obtained by the Secretary. "(2) Every person required under this section to maintain records. Access to recand every person having charge or custody thereof, shall, upon request °'"^^of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records." (b) Section 507(d) of such Act (21 U.S.C. 357(d)) is amended by 59 Stat. 463. adding at the end thereof the following new sentences: "Such regula- Regulations pertions may, within the discretion of the Secretary, among other condi- taining to exemptions relating to the protection of the public health, provide for con- tion. ditioning the exemption under clause (3) upon— "(1) the submission to the Secretary, before any clinical testing of a new drug is undertaken, of reports, by the manufacturer or the sponsor of the investigation of such drug, of preclinical tests (including tests on animals) of such drug adequate to justify the proposed clinical testing; I "(2) the manufacturer or the sponsor of the investigation of a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each of such investigators that patients to whom the drug is administered will be under his personal supervision, or under the supervision of investigators responsible to him, and that he will not supply such drug = to any other investigator, or to clinics, for administration to human beings; and "(3) the establishment and maintenance of such records, and . the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such drug, of data (including but not limited to analytical reports by investigators) obtained as the result of such investigational use of such drug, as the Secretary finds will enable him to evaluate the safety and effectiveness of such drug in the event of the filing of an application for certification or release pursuant to subsection (a).
�
