§360aaa–4. Corrective actions; cessation of dissemination
(a) Postdissemination data regarding safety and effectiveness
(1) Corrective actions
With respect to data received by the Secretary after the dissemination of information under section 360aaa of this title by a manufacturer has begun (whether received pursuant to paragraph (2) or otherwise), if the Secretary determines that the data indicate that the new use involved may not be effective or may present a significant risk to public health, the Secretary shall, after consultation with the manufacturer, take such action regarding the dissemination of the information as the Secretary determines to be appropriate for the protection of the public health, which may include ordering that the manufacturer cease the dissemination of the information.
(2) Responsibilities of manufacturers to submit data
After a manufacturer disseminates information under section 360aaa of this title, the manufacturer shall submit to the Secretary a notification of any additional knowledge of the manufacturer on clinical research or other data that relate to the safety or effectiveness of the new use involved. If the manufacturer is in possession of the data, the notification shall include the data. The Secretary shall by regulation establish the scope of the responsibilities of manufacturers under this paragraph, including such limits on the responsibilities as the Secretary determines to be appropriate.
(b) Cessation of dissemination
(1) Failure of manufacturer to comply with requirements
The Secretary may order a manufacturer to cease the dissemination of information pursuant to section 360aaa of this title if the Secretary determines that the information being disseminated does not comply with the requirements established in this part. Such an order may be issued only after the Secretary has provided notice to the manufacturer of the intent of the Secretary to issue the order and (unless paragraph (2)(B) applies) has provided an opportunity for a meeting with respect to such intent. If the failure of the manufacturer constitutes a minor violation of this part, the Secretary shall delay issuing the order and provide to the manufacturer an opportunity to correct the violation.
(2) Supplemental applications
The Secretary may order a manufacturer to cease the dissemination of information pursuant to section 360aaa of this title if-
(A) in the case of a manufacturer that has submitted a supplemental application for a new use pursuant to section 360aaa–3(a)(1) of this title, the Secretary determines that the supplemental application does not contain adequate information for approval of the new use for which the application was submitted;
(B) in the case of a manufacturer that has submitted a certification under section 360aaa–3(b) of this title, the manufacturer has not, within the 6-month period involved, submitted the supplemental application referred to in the certification; or
(C) in the case of a manufacturer that has submitted a certification under section 360aaa–3(c) of this title but has not yet submitted the supplemental application referred to in the certification, the Secretary determines, after an informal hearing, that the manufacturer is not acting with due diligence to complete the studies involved.
(3) Termination of deemed approval of exemption regarding supplemental applications
If under section 360aaa–3(d)(3) of this title the Secretary terminates a deemed approval of an exemption, the Secretary may order the manufacturer involved to cease disseminating the information. A manufacturer shall comply with an order under the preceding sentence not later than 60 days after the receipt of the order.
(c) Corrective actions by manufacturers
(1) In general
In any case in which under this section the Secretary orders a manufacturer to cease disseminating information, the Secretary may order the manufacturer to take action to correct the information that has been disseminated, except as provided in paragraph (2).
(2) Termination of deemed approval of exemption regarding supplemental applications
In the case of an order under subsection (b)(3) of this section to cease disseminating information, the Secretary may not order the manufacturer involved to take action to correct the information that has been disseminated unless the Secretary determines that the new use described in the information would pose a significant risk to the public health.
(June 25, 1938, ch. 675, §555, as added
Termination of Section
For termination of section by section 401(e) of
Section Referred to in Other Sections
This section is referred to in sections 360aaa–2, 360aaa–3 of this title.