,i #aacth ,,congress #ast ,session ,h4 ,r4 #bjij ,,in ,,the ,,house ,,of ,,representatives ,may #bb1 #bjac ,mr4 ,griffith of ,virginia 7for himself1 ,mr4 ,mc,caul1 and ,mr4 ,peters of ,california7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act to permit provisional approval of fast track products4 #a4 ,short title ,this ,act may be cited as the ,patient ,choice ,act of #bjac4 #b4 ,provisional approval for fast track products 7a7 ,in general ,section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is amended by adding at the end the following3 7f7 ,provisional approval 7#a7 ,provisional approval for adequately safe fast track products 7,a7 ,in general ,subject to the requirements of this subsection1 if the ,secretary determines that a drug that is designated as a fast track product under this section is adequately safe 7as such term is defined in paragraph 7#b771 the ,secretary shall grant provisional approval and the drug may be introduced into interstate commerce on or after the date such provisional approval is granted4 7,b7 ,treatment of provisional approval status ,the provisional approval of a drug under subparagraph 7,a7 shall be treated in the same manner as approval of a drug under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 except that such provisional approval shall be subject to the requirements of this section1 including the following3 7i7 ,the requirements under paragraph 7#c71 including requirements related to-- 7,i7 informed consent2 and 7,,ii7 continued pursuit of safety and efficacy data for purposes of gaining approval for such drug under section #eje of this ,act or section #cea of the ,public ,health ,service ,act4 7ii7 ,the rules under paragraphs 7#d7 and 7#e7 relating to the length of the termination of the provisional approval and withdrawal of a drug subject to provisional approval4 7,c7 ,request for provisional approval 7i7 ,in general ,the sponsor of a drug that is designated as a fast track product under this section may request that the ,secretary grant provisional approval for such drug under subparagraph 7,a74 7ii7 ,response to request ,not later than #ij days after receiving such a request1 the ,secretary shall either-- 7,i7 grant provisional approval for the drug under subparagraph 7,a72 or 7,,ii7 provide notice to the sponsor of the drug that such request is denied4 7#b7 ,adequately safe defined 7,a7 ,in general ,for purposes of this subsection1 with respect to a drug1 the term adequately safe means that-- 7i7 for at least one population1 the risk of death or morbidity caused directly by an adverse effect of the drug1 as determined in one or more safety studies or through other data that the ,secretary determines are sufficient1 is unlikely to be greater than the combined direct and secondary risks of death or morbidity1 as established in the literature or historical data1 of-- 7,i7 the disease that such drug is intended to treat2 and 7,,ii7 existing therapies 7including infection7 for such disease2 or 7ii7 the drug has had a valid marketing authorization1 for a period of at least #d years1 by an authority in a country described in section #hjb7;b77#a77;,a71 or designated by the ,secretary under section #hjb7;b77#a77;,b71 and data adequate for the approval of such marketing authorization for such drug in such country have been submitted to the ,secretary4 7,b7 ,limitation ,the ,secretary may not impose any requirements for purposes of the safety studies or data under subparagraph 7,a77i7 that are in addition to1 or different than1 the requirements for studies to establish safety for purposes of ,phase #a or ,phase #b1 as such terms are described in subsections 7a7 and 7b71 respectively1 of section #cab4ba of title #ba1 ,code of ,federal ,regulations4 7#c7 ,requirements ,provisional approval of a fast track product under this subsection shall be subject to the following requirements3 7,a7 ,informed consent 7i7 ,in general ,as a condition of provisional approval under paragraph 7#a71 the sponsor of a drug shall ensure that1 before such drug is dispensed to an individual-- 7,i7 the individual shall be informed that the drug is subject to provisional approval based on limited safety data and that the efficacy of the drug has not been proven2 7,,ii7 the individual shall be informed of the known risks of the drug and any unknown but reasonably predictable risks of the drug1 including1 as appropriate1 potential risks of death1 complications1 or injury resulting from use of the drug1 and risks related to the potential ineffectiveness of the drug1 including progression of the disease that may result in death or morbidity1 or the potential for the drug to accelerate or exacerbate the disease process2 and 7,,iii7 the individual provides written informed consent acknowledging that individual has been provided with and understands the information under subclauses 7,i7 or 7,,ii74 7ii7 ,regulations ,the ,secretary shall issue regulations on the requirements for informed consent under clause 7i74 ,such regulations shall be similar to the requirements for informed consent for human subjects under subpart ,b of part #ej of title #ba1 ,code of ,federal ,regulations1 adjusted as appropriate for purposes of this subsection4 7,b7 ,pursuit of full approval required ,a sponsor of a drug that receives a provisional approval under paragraph 7#a7 shall continue to diligently conduct appropriate studies1 after such provisional approval is granted1 to-- 7i7 establish that the drug has an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit2 and 7ii7 collect the data necessary to demonstrate that the drug is safe and effective 7or1 in the case of a biologic1 safe and potent7 for purpose of obtaining approval for such drug under section #eje7;c7 of this ,act or section #cea of the ,public ,health ,service ,act4 7,c7 ,promotional materials ,during the period that provisional approval under paragraph 7#a7 applies to a drug1 the sponsor of the drug shall submit copies of all promotional materials related to the drug at least #cj days prior to dissemination of the materials4 7,d7 ,risk evaluation and mitigation strategy 7i7 ,in general ,section #eje-a shall apply to a drug subject to provisional approval under this subsection in the same manner that such section applies to a drug approved under section #eje of this ,act or section #cea of the ,public ,health ,service ,act4 7ii7 ,rule of construction ,nothing in this subparagraph shall be construed to limit the ,secretary's authority under section #eje-a to determine if a risk evaluation and mitigation strategy is necessary4 7,e7 ,indication of use ,the provisional approval under paragraph 7#a7 shall only apply to the indication of use for the drug-- 7i7 which is related to the treatment of the condition with respect to which such drug was designated as a fast track product2 and 7ii7 for which the drug is demonstrated to be adequately safe4 7#d7 ,termination of provisional approval 7,a7 ,in general ,in the case of a drug that is not designated under section #ebf1 the provisional approval of the drug under paragraph 7#a7 shall terminate on the earlier of the following3 7i7 ,the date that the drug is approved under section #eje7;c7 of this ,act or section #cea of the ,public ,health ,service ,act4 7ii7 ,at the end of the #e-year period beginning on the date on which provisional approval was granted for such drug1 except-- 7,i7 if the ,secretary determines that the sponsor of the drug is diligently engaging in actions 7including conducting clinical trials7 for the purpose of seeking approval under section #eje7;c7 of this ,act or section #cea of the ,public ,health ,service ,act 7excluding provisional approval under paragraph 7#a77 and the ,secretary determines that the sponsor requires additional time to complete such actions and attain such approval1 the ,secretary may extend such period for an appropriate length of time to allow the sponsor to complete such actions and attain such approval2 or 7,,ii7 if the ,secretary determines that the termination of the provisional approval is adverse to protecting or promoting the public health1 the ,secretary may extend such period for an appropriate length of time to protect or promote the public health4 7,b7 ,special rule for orphan drugs ,in the case of a drug designated under section #ebf1 the provisional approval of the drug under paragraph 7#a7 shall terminate on the date that the drug is approved under section #eje7;c7 of this ,act or section #cea of the ,public ,health ,service ,act4 7,c7 ,rule of construction ,for purposes of this paragraph1 the phrase approved under section #eje7;c7 of this ,act or section #cea of the ,public ,health ,service ,act shall not be construed to include a provisional approval under paragraph 7#a74 7#e7 ,withdrawal 7,a7 ,in general ,subsection 7b77#c7 shall apply to a drug subject to a provisional approval under this subsection in the same manner as such subsection applies to any fast track product4 7,b7 ,additional withdrawal authority ,in addition to subparagraph 7,a71 the ,secretary may withdraw approval of a fast track product using the expedited procedures applied under subsection 7b77#c7 if the requirements of paragraph 7#c77;,a7 have not been met with respect to the drug4 7#f7 ,impact on marketing exclusivity ,the rules related to marketing exclusivity under sections #eje7;c77#c77;,e71 #eje7;j77#e77;,f71 #eje;,a1 and #ebg shall apply to a drug subject to provisional approval under this subsection in the same manner that such rules apply to drugs approved under section #eje of this ,act or section #cea of the ,public ,health ,service ,act1 except that the period of provisional approval under this subsection for a drug shall be an addition to the applicable period of marketing exclusivity for such drug4 4 7b7 ,misbranding for marketing of terminated drug ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by adding at the end the following3 7bb7 ,if it is a drug that is introduced or delivered for introduction into interstate commerce after the date of the termination of the provisional approval for such drug under section #ejf7;f71 unless1 on or before the date such drug is so introduced or delivered1 such drug is approved under section #eje7;c7 of this ,act or section #cea of the ,public ,health ,service ,act4 4 7c7 ,conforming amendments ,the chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea7 is further amended-- 7#a7 in section #ejb7;a71 by inserting 7or an indication subject to a provisional approval under section #ejf7;f77 after an indication approved under section #eje or under section #cea7;a7 of the ,public ,health ,service ,act2 7#b7 in section #ejf;,a-- 7,a7 in subsection 7a71 by inserting 7or a provisional approval under section #ejf7;f77 after a license under section #cea of the ,public ,health ,service ,act2 and 7,b7 by adding at the end the following3 7e7 ,special rule for drugs subject to provisional approval ,in the case of a drug subject to a provisional approval under section #ejf7;f71 any reference to safety and efficacy under this section shall be treated as a reference to adequate safety1 as such term is defined for purposes of such section #ejf7;f74 2 7#c7 in section #ejf;,b7a71 by adding at the end the following3 7#c7 ,special rule for provisional approval ,a sponsor of a drug that is subject to a provisional approval under section #ejf7;f7 shall submit the reports required under this section on the studies conducted on such drug that are described in section #ejf7;f77#c77;,b74 ,for purposes of this section1 such reports shall be treated as reports on postmarketing studies described in paragraph 7#a74 2 and 7#d7 in section #eea7;b77#a77;,a7 by inserting 7or a provisional approval under section #ejf7;f77 after ,public ,health ,service ,act4