[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2423 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 2423

To amend the Federal Food, Drug, and Cosmetic Act with respect to valid 
                          scientific evidence.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 19, 2015

 Mr. Shimkus introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act with respect to valid 
                          scientific evidence.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. VALID SCIENTIFIC EVIDENCE.

    Section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360c(a)(3)(B)) is amended--
            (1) by redesignating clauses (i) and (ii) as subclauses (I) 
        and (II), respectively;
            (2) by striking ``(B) If the Secretary'' and inserting 
        ``(B)(i) If the Secretary''; and
            (3) by adding at the end the following:
                    ``(ii) Valid scientific evidence for purposes of 
                clause (i) may include:
                            ``(I) evidence described in well-documented 
                        case histories, including registry data, that 
                        are collected and monitored under an acceptable 
                        protocol;
                            ``(II) studies published in peer-reviewed 
                        journals; and
                            ``(III) data collected in countries other 
                        than the United States so long as such data 
                        otherwise meets the criteria specified in this 
                        subparagraph.
                    ``(iii) In the case of a study published in a peer-
                reviewed journal that is offered as valid scientific 
                evidence for purposes of clause (i), the Secretary may 
                request data underlying the study if--
                            ``(I) the Secretary, in making such 
                        request, complies with the requirement of 
                        subparagraph (D)(ii) to consider the least 
                        burdensome appropriate means of evaluating 
                        device effectiveness or subsection (i)(1)(D) to 
                        consider the least burdensome means of 
                        determining substantial equivalence, as 
                        applicable;
                            ``(II) the Secretary furnishes a written 
                        rationale for so requesting the underlying data 
                        together with such request; and
                            ``(III) if the requested underlying data 
                        for such a study are unavailable, the Secretary 
                        shall consider such study to be part of the 
                        totality of the evidence with respect to the 
                        device, as the Secretary determines 
                        appropriate.''.
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