TEST Act

Summary:  Trial and Experimental Studies Transparency Act of 2012 [sic] or TEST Act - Amends the Public Health Service Act to expand the clinical trials that must be reported to the clinical trial registry data bank to include: (1) any interventional study of a drug, device, or biological product conducted outside of the United States the results of which are submitted to the Secretary of Health and Human Services (HHS) as support for approval of an application; and (2) postmarket surveillance of a class II or class III device that involves data collection from human subjects. Defines &quot;interventional study&quot; to mean a study in human beings in which individuals are assigned by an investigator, based on a protocol, to receive specific interventions to evaluate their effects on biomedical health-related outcomes. Requires submission to the data bank of supporting documents, including protocol documents and consent documents used to enroll subjects into the trial. Requires the responsible party for a clinical trial to submit clinical trial information to the data bank before the first patient is enrolled in the trial. Requires the Director of the National Institutes of Health (NIH) to post the information submitted to the data bank within 30 days after the submission is determined to meet the quality criteria established by the Director. Revises time frames for the reporting of results data to the clinical trial registry. Requires the Director and the Commissioner of Food and Drugs (FDA) to report on the number of clinical trials with information submitted to the registry and steps taken to enforce compliance with such reporting requirements.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Trial and Experimental Studies 
Transparency Act of 2012'' or the ``TEST Act''.

SEC. 2. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

    (a) In General.--Section 402(j) of the Public Health Service Act 
(42 U.S.C. 282(j)) is amended--
            (1) in paragraph (1)(A)--
                    (A) in clause (ii)--
                            (i) by amending subclause (I) to read as 
                        follows:
                                    ``(I) an interventional study of a 
                                device subject to section 510(k), 515, 
                                or 520(m) of the Federal Food, Drug, 
                                and Cosmetic Act, including any 
                                interventional study of a device 
                                conducted outside of the United States 
                                the results of which are submitted to 
                                the Secretary in support of a PMA (as 
                                such term is defined in section 
                                814.3(e) of title 21, Code of Federal 
                                Regulations); a premarket notification 
                                required under section 510(k) of the 
                                Federal Food, Drug, and Cosmetic Act; 
                                or a HDE (as such term is defined in 
                                section 814.3(m) of title 21, Code of 
                                Federal Regulations).''; and
                            (ii) in subclause (II)--
                                    (I) by striking ``pediatric''; and
                                    (II) by inserting ``that involves 
                                data collection from human subjects'' 
                                before the period at the end;
                    (B) by amending clause (iii) to read as follows:
                            ``(iii) Applicable drug clinical trial.--
                        The term `applicable drug clinical trial' means 
                        an interventional study of a drug subject to 
                        section 505 of the Federal Food, Drug, and 
                        Cosmetic Act or to section 351 of this Act, 
                        including any interventional study of a drug 
                        conducted outside of the United States the 
                        results of which are submitted to the Secretary 
                        in support of--
                                    ``(I) an IND (as such term is 
                                defined in section 312.3 of title 21, 
                                Code of Federal Regulations);
                                    ``(II) an application filed under 
                                subsection (b) or (j) of such section 
                                505 of the Federal Food, Drug, and 
                                Cosmetic Act; or
                                    ``(III) an application for a 
                                license under section 351.'';
                    (C) by redesignating clauses (iv) through (ix) as 
                clauses (v) through (x), respectively;
                    (D) after clause (iii), by inserting the following 
                new clause:
                            ``(iv) Interventional study.--For purposes 
                        of clauses (ii) and (iii), the term 
                        `interventional study' means a study in human 
                        beings in which individuals are assigned by an 
                        investigator, based on a protocol, to receive 
                        specific interventions to evaluate their 
                        effects on biomedical or health-related 
                        outcomes.''; and
                    (E) in clause (vi), as redesignated by subparagraph 
                (C)--
                            (i) in the heading, by inserting ``; 
                        primary completion date'' after ``date''; and
                            (ii) by inserting ``, also referred to as 
                        `primary completion date','' before ``means'';
            (2) in paragraph (2)--
                    (A) in subparagraph (A)(ii)--
                            (i) by redesignating subclauses (II), 
                        (III), and (IV) as subclauses (III), (IV), and 
                        (V), respectively;
                            (ii) by inserting after subclause (I) the 
                        following:
                                    ``(II) supporting documents, 
                                including--
                                            ``(aa) consent documents 
                                        used to enroll subjects into 
                                        the trial, as approved by the 
                                        Institutional Review Board or 
                                        equivalent committee prior to 
                                        the start of the trial; and
                                            ``(bb) protocol documents, 
                                        as approved by the 
                                        Institutional Review Board or 
                                        equivalent committee prior to 
                                        the start of the trial;''; and
                            (iii) in subclause (IV), as so 
                        redesignated, in item (cc), by inserting ``(or, 
                        in the case of a location outside of the United 
                        States, other appropriate location 
                        information)'' after ``zip code'';
                    (B) in subparagraph (C)(ii) by striking ``21 days 
                after'' and inserting ``before''; and
                    (C) by amending subparagraph (D) to read as 
                follows:
                    ``(D) Posting of data.--The Director of NIH shall 
                ensure that clinical trial information for an 
                applicable clinical trial submitted in accordance with 
                this paragraph is posted publically in the registry 
                data bank not later than 30 days after such submission 
                is determined to meet the quality criteria established 
                by the Director of NIH.'';
            (3) in paragraph (3)--
                    (A) in subparagraph (C)--
                            (i) by striking ``Not later than 1 year'' 
                        and all that follows through the colon and 
                        inserting ``Subject to subparagraph (2)(C), the 
                        Secretary shall include in the registry and 
                        results data bank the following elements for an 
                        applicable clinical trial:''; and
                            (ii) by adding at the end the following new 
                        clause:
                            ``(v) Supporting documents.--Final consent 
                        and protocol documents, including all dated 
                        amendments to the initial version of such 
                        documents, as approved by the Institutional 
                        Review Board or equivalent committee.'';
                    (B) in subparagraph (D)--
                            (i) by striking clauses (ii) and (iv);
                            (ii) in clause (iii)--
                                    (I) by striking subclause (III); 
                                and
                                    (II) by redesignating subclause 
                                (IV) as subclause (III); and
                            (iii) by redesignating--
                                    (I) clause (iii) as clause (ii); 
                                and
                                    (II) clauses (v) through (vii) as 
                                clauses (iii) through (v), 
                                respectively;
                    (C) in subparagraph (E)--
                            (i) by striking clauses (i) through (v) and 
                        inserting the following:
                            ``(i) In general.--Except as provided in 
                        clauses (ii) and (iii), the responsible party 
                        for an applicable clinical trial shall submit 
                        to the Director of NIH for inclusion in the 
                        registry and results data bank the clinical 
                        trial information described in subparagraph (C) 
                        not later than 1 year after the primary 
                        completion date of such trial.
                            ``(ii) Delayed submission of results with 
                        certification.--If the responsible party for an 
                        applicable clinical trial submits a 
                        certification that an applicable clinical trial 
                        involves a drug described in clause (iii) or a 
                        device described in clause (iv), the 
                        responsible party shall submit to the Director 
                        of NIH, for inclusion in the registry and 
                        results data bank, the clinical trial 
                        information described in subparagraphs (C) and 
                        (D) not later than the earliest of the 
                        following:
                                    ``(I) The later of--
                                            ``(aa) 30 days after the 
                                        drug or device is approved, 
                                        licensed, or cleared, as 
                                        applicable; or
                                            ``(bb) 1 year after the 
                                        primary completion date of the 
                                        applicable clinical trial.
                                    ``(II) The date that is 2 years 
                                after the primary completion date of 
                                the applicable clinical trial.
                            ``(iii) Drug described.--A drug described 
                        in this clause is a drug that contains an 
                        active ingredient, including any ester or salt, 
                        that has not been an ingredient in a drug 
                        approved in any other application under section 
                        505 of the Federal Food, Drug, and Cosmetic Act 
                        or licensed for any use under section 351 of 
                        this Act.
                            ``(iv) Device described.--A device 
                        described in this clause is a device that has 
                        not been approved or cleared for any use under 
                        section 510(k) or under section 515 or 520(m) 
                        of the Federal Food, Drug, and Cosmetic Act.'';
                            (ii) by redesignating clause (vi) as clause 
                        (v); and
                            (iii) by adding at the end the following:
                            ``(vi) Public postings related to delays 
                        and extensions.--Information submitted by the 
                        responsible party as part of a certification 
                        for delayed submission of results submitted 
                        under clause (ii) or a request for extension 
                        submitted under clause (v) shall be posted 
                        publically in the registry data bank.'';
                    (D) by striking subparagraph (F);
                    (E) by redesignating subparagraphs (G) through (I) 
                as subparagraphs (F) through (H), respectively; and
                    (F) in subparagraph (F), as so redesignated, by 
                inserting before the period at the end the following: 
                ``is determined to meet the quality criteria 
                established by the Director of NIH''; and
            (4) in paragraph (4)(B)--
                    (A) in clause (i)(II), by striking ``(3)(E)(iii)'' 
                and inserting ``(3)(E)(ii)''; and
                    (B) in clause (ii)(II)--
                            (i) by striking ``by both''; and
                            (ii) by striking ``and paragraph 
                        (3)(D)(ii)(II))''.
    (b) Implementation.--The Secretary of Health and Human Services 
shall implement the amendments made by subsection (a) not later than 6 
months after the date of enactment of this Act.

SEC. 3. REPORTING REQUIREMENT.

    Not later than 2 years after the date of the enactment of this Act, 
and annually thereafter, the Director of the National Institutes of 
Health and the Commissioner of the Food and Drug Administration shall 
each submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report that includes the following:
            (1) Based on information that is readily available in the 
        data bank described in section 402(j) of the Public Health 
        Service Act (42 U.S.C. 282(j))--
                    (A) the number of trials that the Director or 
                Commissioner, as applicable, has identified as trials 
                that are likely to be subject to the reporting 
                requirements of such section;
                    (B) of the trials identified under subparagraph 
                (A), the estimated numbers and percentages of such 
                trials--
                            (i) that have complete registration 
                        information; and
                            (ii) that have met the result reporting 
                        requirements of section 402(j) of the Public 
                        Health Service Act; and
                    (C) whether results of the trials have been 
                submitted by the responsible party by the due dates 
                outlined in section 402(j) of the Public Health Service 
                Act and, if not, whether certifications for delayed 
                submission of such results, or requests for extensions, 
                have been submitted by the responsible party.
        For purposes of this paragraph, the Secretary may use an 
        algorithm or other technique for efficiently reviewing large 
        amounts of data.
            (2) A description of any actions taken to consult with 
        other Federal agencies under 402(j)(5)(A)(iv) of the Public 
        Health Service Act.
            (3) In the case of a report submitted by the Commissioner 
        of the Food and Drug Administration, a description of any 
        enforcement actions taken for violations of section 301(jj) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(jj)), 
        including--
                    (A) warning letters or fines imposed related to 
                reporting requirements; and
                    (B) any inquiries made to responsible parties to 
                inform those parties of any potential enforcement 
                action.
            (4) In the case of a report submitted by the Director of 
        the National Institutes of Health, a description of any actions 
        taken to withhold grant funds from responsible parties that are 
        not compliant with the requirements of this section as 
        indicated in 402(j)(5)(A) of the Public Health Service Act.

SEC. 4. RULEMAKING RELATED TO FOREIGN CLINICAL STUDIES.

    (a) Drugs.--Not later than 1 year after the date of enactment of 
this Act, the Secretary of Health and Human Services shall issue final 
regulations to amend section 312.120 of title 21, Code of Federal 
Regulations (relating to foreign clinical studies not conducted under 
an IND) to require that clinical trial information for such a foreign 
clinical study be submitted for inclusion in the registry and results 
data bank in accordance with section 402(j) of the Public Health 
Service Act (42 U.S.C. 282(j)), as amended by this Act, as a condition 
for the acceptance of such study as support for an IND (as such term is 
defined in section 312.3 of title 21, Code of Federal Regulations) or 
application for marketing approval (an application under section 505 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 
of the Public Health Service Act (42 U.S.C. 262)).
    (b) Devices.--Not later than 1 year after the date of enactment of 
this Act, the Secretary of Health and Human Services shall issue final 
regulations (including regulations amending section 814.15 of title 21, 
Code of Federal Regulations (relating to research conducted outside the 
United States)) to require that clinical trial information for studies 
conducted outside the United States be submitted for inclusion in the 
registry and results data bank in accordance with section 402(j) of the 
Public Health Service Act (42 U.S.C. 282(j)), as amended by this Act, 
as a condition for the acceptance of such studies to support a PMA (as 
such term is defined in section 814.3(e) of title 21, Code of Federal 
Regulations), a premarket notification required under section 510(k) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)), or HDE (as 
such term is defined in section 814.3(m) of title 21, Code of Federal 
Regulations).