S.Amdt. 997

1. 1

   Change 1: Rewrites section 402(j)(3)(A)(i)

   ReplacesSection 402(j)(3)(A)(i) of the Public Health Service Act

   Removes section 402(j)(3)(A)(i).

   Inserted: (i) In general.--

   Inserted: (I) Requirement.--Not later than 90 days after the date of enactment of the Food and Drug Administration Revitalization Act, for all clinical trials (except as provided in subclause (II)), whether federally or privately funded, conducted to test the safety or efficacy (including comparative efficacy), of any drug or device (including those drugs or devices approved or cleared by the Secretary), the Secretary shall ensure that the registry data bank includes links to results information for such clinical trial--

   Inserted: (aa) not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device involved; or

   Inserted: (bb) not later than 30 days after such information becomes publicly available, as applicable.

   Inserted: (II) Exception.--The requirement of subclause (I) shall not apply to phase I clinical investigations conducted to test solely the safety of an unapproved drug or unlicensed biological product, or pilot or feasibility studies conducted to confirm the design and operating specifications of an unapproved or not yet cleared medical device.

   Inserted: (III) Voluntary submission.--A responsible party for a clinical trial that is not an applicable drug clinical trial or an applicable device clinical trial may submit to the Secretary results information for a clinical trial described in subclause (II).

   Original wording

   Strike clause (i) of section 402(j)(3)(A) of the Public Health Service Act, as added by this bill, and insert the following:

2. 2

   Change 2: Inserts new text at the end of section 402(j)(4) of the Public Health Service Act

   Inserts

   Inserted: (F) Trials conducted outside of the united states.--

   Inserted: (i) In general.--With respect to clinical trials described in clause (ii), the responsible party shall submit to the Secretary the information required under this subsection. The Secretary shall ensure that such information and the results of such clinical trials are made available to the public in a timely manner and as soon as practicable after receiving such information. Failure to comply with this paragraph shall be deemed to be a failure to submit information as required under this subsection, and the appropriate remedies and sanctions under this section shall apply.

   Inserted: (ii) Clinical trial described.--A clinical trial is described in this clause if--

   Inserted: (I) such trial is conducted outside of the United States; and

   Inserted: (II) the data from such trial is--

   Inserted: (aa) submitted to the Secretary as part of an application, including a supplemental application, for a drug or device under section 505, 510, 515, or 520 of the Federal Food, Drug, and Cosmetic Act or for the biological product under section 351 of this Act; or

   Inserted: (bb) used in advertising or labeling to make a claim about the drug or device involved.

   Original wording

   At the end section 402(j)(4) of the Public Health Service Act, as added by this bill, insert the following:

Read automatically from the Congressional Record. Check the original before relying on it.

As printed