,i #aafth ,,congress #ast ,session ,h4 ,r4 #edjb ,,in ,,the ,,house ,,of ,,representatives ,december #aa1 #bjai,mr4 ,gottheimer 7for himself and ,mr4 ,upton7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committee on ,energy and ,commerce1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to direct the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 to conduct a study on high-risk1 high-reward drugs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,protecting ,america's ,life ,saving ,medicines ,act of #bjai4 #b4 ,study on high-risk1 high-reward drugs 7a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall conduct a study to determine which of the drugs that are being tested 7as of such date of enactment7 under subsection 7i7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 are unlikely to be approved under subsection 7c7 of such section1 but would1 if approved1 address an unmet medical need for the treatment of a serious or life-threatening disease or condition or a rare disease or condition4 7b7 ,submission to ,treasury ,not later than #ahj days after the completion of the study under subsection 7a71 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall transmit to the ,secretary of the ,treasury 7or the ,secretary's delegate7 a list of the drugs that the ,secretary of ,health and ,human ,services determines meets the criteria specified in subsection 7a74 #c4 ,credit for clinical testing expenses for certain high-risk1 high-reward drugs 7a7 ,in general ,subpart ,d of part ,,iv of subchapter ,a of chapter #a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #de,t4 ,clinical testing expenses for certain high-risk1 high-reward drugs 7a7 ,in general ,for purposes of section #ch1 the credit determined under this section for the taxable year is an amount equal to #be percent of the qualified clinical testing expenses for the taxable year4 7b7 ,qualified clinical testing expenses ,for purposes of this section-- 7#a7 ,qualified clinical testing expenses 7,a7 ,in general ,except as otherwise provided in this paragraph1 the term qualified clinical testing expenses means the amounts which are paid or incurred by the taxpayer during the taxable year which would be described in subsection 7b7 of section #da if such subsection were applied with the modifications set forth in subparagraph 7,b74 7,b7 ,modifications ,for purposes of subparagraph 7,a71 subsection 7b7 of section #da shall be applied-- 7i7 by substituting clinical testing for qualified research each place it appears in paragraphs 7#b7 and 7#c7 of such subsection1 and 7ii7 by substituting #ajj percent for #fe percent in paragraph 7#c77;,a7 of such subsection4 7,c7 ,exclusion for amounts funded by grants1 etc ,the term qualified clinical testing expenses shall not include any amount to the extent such amount is funded by any grant1 contract1 or otherwise by another person 7or any governmental entity74 7#b7 ,clinical testing ,the term clinical testing means any human clinical testing-- 7,a7 which is carried out with respect to a drug on a list submitted to the ,secretary under subsection 7b7 of the ,protecting ,america's ,life ,saving ,medicines ,act of #bjai1 7,b7 which occurs-- 7i7 after the date such list is so submitted1 and 7ii7 before the date on which an application with respect to such drug is approved under section #eje7;b7 of such ,act or1 if the drug is a biological product1 before the date on which a license for such drug is issued under section #cea of the ,public ,health ,service ,act4 7c7 ,coordination with credit for increasing research expenditures 7#a7 ,in general ,except as provided in paragraph 7#b71 any qualified clinical testing expenses for a taxable year to which an election under this section applies shall not be taken into account for purposes of determining the credit allowable under section #da for such taxable year4 7#b7 ,expenses included in determining base period research expenses ,any qualified clinical testing expenses for any taxable year which are qualified research expenses 7within the meaning of section #da7;b77 shall be taken into account in determining base period research expenses for purposes of applying section #da to subsequent taxable years4 7d7 ,special rules 7#a7 ,certain rules made applicable ,rules similar to the rules of paragraphs 7#a7 and 7#b7 of section #da7;f7 shall apply for purposes of this section4 7#b7 ,election ,this section shall apply to any taxpayer for any taxable year only if such taxpayer elects 7at such time and in such manner as the ,secretary may by regulations prescribe7 to have this section apply for such taxable year4 4 7b7 ,credit made part of general business credit ,subsection 7b7 of section #ch of the ,internal ,revenue ,code of #aihf is amended by striking plus at the end of paragraph 7#ca71 by striking the period at the end of paragraph 7#cb7 and inserting 1 plus1 and by adding at the end the following new paragraph3 7#cc7 the credit determined under section #de,t4 4 7c7 ,clerical amendment ,the table of sections for subpart ,d of part ,,iv of subchapter ,a of chapter #a of such ,code is amended by adding at the end the following new item3 ,sec4 #de,t4 ,clinical testing expenses for certain high-risk1 high-reward drugs44 7d7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after the date of the enactment of this ,act4