Opinion ID: 64717
Heading Depth: 3
Heading Rank: 1

Heading: The Scope of Section 355(i)

Text: Section 355(i) states: (i) Exemptions of drugs for research; discretionary and mandatory conditions; direct reports to Secretary. (1) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. Such regulations may, within the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon  . . . . (C) 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 pursuant to subsection (b); and . . . . (4) Regulations under paragraph (1) shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible or it is contrary to the best interests of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Secretary reports on the investigational use of drugs. 21 U.S.C. 355(i) (emphasis added). Based on the text of the statute, it is clear that § 355(i) addresses three separate issues regarding clinical drug testing. First, § 355(i) explicitly requires the Secretary of the FDA to promulgate regulations providing exemptions of drugs for research from earlier subsections contained in 21 U.S.C. § 355, which regulate New Drugs. Second, § 355(i) allows the Secretary, in his/her discretion, to issue regulations regarding those exemptions in an effort to protect[ ] the public health. Section 355(i) provides a non-exhaustive list of conditions upon which the Secretary may provide exemptions. Third, § 355(i) provides requirements for sponsors and manufacturers to make direct reports to the Secretary and explicitly states that clinical investigators are not required to submit reports directly to the Secretary. On its face, § 355(i) does not provide criminal liability for sponsors and manufacturers of investigational drug studies or clinical investigators. Violations of § 355(i) are prohibited in 21 U.S.C. § 331(e), and criminal penalties for violating § 331(e) are found in 21 U.S.C. § 333(a). In addition, § 355(i) does not contain an explicit requirement governing the conduct of clinical investigators. The record-keeping and reporting requirements applicable to clinical investigators are contained in the regulations promulgated by the FDA in accordance with the authority given the FDA by Congress. Thus, we must turn to §§ 331(e) and 333 and the FDA's regulations concerning clinical investigators to determine whether clinical investigators are subject to criminal liability for failing to adhere to certain record-keeping and reporting requirements.