FDA has several options that enable enforcement of the new informed consent
requirement. FDA has the authority to regulate the protection of human subjects and the
authority to impose penalties for violations of these regulations. The Food, Drug, and
Cosmetic Act (FD&C Act) prohibits the failure to establish or maintain any record or
make any report required under section 505(i) and the failure or refusal to comply with
any requirement under 520(g). 21 U.S.C. § 331(e) “The FD&C Act and implementing
regulations allow FDA to seek administrative, civil, and criminal penalties for violations
of section 301 of the FD&C Act. 21 U.S.C. § 303(a); §§ 312.44(b)(1)(ix), 312.70(a),
812.30(b)(4), 812.119(a), 56.121(b).” 76 FR 256 at 265.
