,,ii #aaeth ,,congress #ast ,session ,s4 #big ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #b1 #bjag,ms4 ,collins 7for herself and ,mrs4 ,mc,caskill7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to increase competition in the pharmaceutical industry4 #a4 ,short title ,this ,act may be cited as the ,increasing ,competition in ,pharmaceuticals ,act 4 #b4 ,findings ,congress finds the following3 7#a7 ,as part of the ,food and ,drug ,administration's mission to protect the public health1 the ,food and ,drug ,administration approves generic drugs that help establish competitive markets for treatments that improve the lives of millions of patients in the ,united ,states4 7#b7 ,rising health care costs1 including prescription drug costs1 continue to be a major concern for patients in the ,united ,states4 7#c7 ,eighty-eight percent of prescription drugs dispensed in the ,united ,states1 or nearly #i out of every #aj prescriptions dispensed1 are generic drugs4 7#d7 ,studies suggest that generic drugs account for only #bh percent of total prescription drug spending and were responsible for #a1fhj1jjj1jjj1jjj in estimated savings over the period of #bjje to #bjad4 7#e7 ,increasing generic competition can be an effective way to help keep prescription drug costs low for patients1 the health care system1 and ,federal and ,state government4 7#f7 ,despite enactment of the ,generic ,drug ,user ,fee ,amendments of #bjab 7#ba ,u4,s4,c4 #cgi;j-#da et seq471 which was established to provide the ,food and ,drug ,administration with industry funding to ensure a more consistent timeline for generic drug approvals1 a significant backlog of abbreviated new drug applications for generic drugs remains4 7#g7 ,the sudden1 aggressive price hikes for a variety of recently acquired off-patent drugs that have been used widely for decades1 for which there is no generic drug competitor1 also affects access to affordable prescriptions for patients and the overall cost of health care in the ,united ,states4 7#h7 ,improving the review of abbreviated new drug applications and the approval of generic drugs would help to improve competition and lower prices for patients4 7#i7 ,establishing a clear timeframe for the ,food and ,drug ,administration to expedite the review of certain applications for generic drugs would also help keep drug prices down and improve timely access for patients4 ,i ,removing regulatory barriers to competition #aja4 ,improving generic access ,section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is amended by adding at the end the following3 7#aa7 7,a7 ,the ,secretary shall prioritize the review1 and act not later than #aej calendar days after the date of the submission of an application1 on an application that has been submitted for review under this subsection1 or on a supplement to such an application1 that is for a drug that-- 7i7 has been introduced into interstate commerce by not more than one manufacturer or sponsor1 as applicable1 in the last #c months and with respect to which tentative approval under paragraph 7#e7 has been granted for not more than #b applications2 or 7ii7 has been included on the list under section #ejf;,e4 7,b7 ,the fees pursuant to section #gdd;,b7a77#c7 shall be waived with respect to an application described in subparagraph 7,a71 unless such application contains a certification under paragraph 7#b77;,a77vii77,,iv74 7,c7 ,the ,secretary may expedite an inspection or reinspection under section #gjd of an establishment that proposes to manufacture a drug described in subparagraph 7,a74 4 #ajb4 ,reporting on pending generic drug applications ,not later than #ij calendar days after the date of enactment of this ,act1 and every #ij calendar days thereafter until ,october #a1 #bjbb1 the ,secretary of ,health and ,human ,services shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 the ,special ,committee on ,aging of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that provides-- 7#a7 the number of applications that were filed under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 prior to ,october #a1 #bjae1 that are pending at the time the report is submitted2 7#b7 the average and median total time such applications have been pending2 7#c7 the number of such applications that contain certifications under section #eje7;j77#b77;,a77vii77,,iv7 of such ,act2 and 7#d7 the number of such applications that are subject to priority review4 ,,ii ,incentivizing competition #bja4 ,generic priority review voucher ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #ejf;,g the following3 #ejf;,h4 ,generic priority review voucher 7a7 ,definitions ,in this section3 7#a7 ,the term priority review with respect to an application under section #eje7;j7 means review and action by the ,secretary on such application by the ,secretary not later than #aej calendar days after such application has been submitted for review4 7#b7 ,the term priority review voucher means a voucher for priority review for an application under section #eje7;j74 ,such voucher shall be awarded upon the approval of the application described in #eje7;j77#aa77;,a71 unless such application contains a certification under subclauses 7,,iii7 and 7,,iv7 of section #eje7;j77#b77;,a77vii74 7b7 ,generic ,priority ,review ,vouchers1 in general ,the ,secretary shall award a priority review voucher to the sponsor of an application described in #eje7;j77#aa77;,a7 upon approval by the ,secretary of such application4 7c7 ,transferability 7#a7 ,in general ,the recipient of a priority review voucher under subsection 7a7 may transfer 7including by sale7 the entitlement to such voucher4 ,there is no limit on the number of times a priority review voucher may be transferred before such voucher is used4 7#b7 ,notification to the ,secretary ,each person to whom a voucher is transferred shall notify the ,secretary of such change in ownership of such voucher not later than #cj calendar days after such transfer4 7d7 ,notification ,the sponsor shall notify the ,secretary not later than #cj calendar days prior to the submission of a human drug application that is intended to be the subject of a priority review voucher1 except in the case of such an application that was pending as of ,october #a1 #bjae1 in which case the sponsor of such pending application shall notify the ,secretary not later than #cj days after the date on which such voucher is awarded4 7e7 ,fees ,the sponsor of an application that is the subject of a priority review voucher shall be subject to the fees required under section #gdd;,a4 7f7 ,clarification ,nothing in this section affects any period of exclusivity under this ,act or the protection of any patent4 7g7 ,revocation ,the ,secretary may revoke any priority review voucher awarded under subsection 7b7 if the drug for which such voucher was awarded is not marketed in the ,united ,states within the #cfe-;day period beginning on the date of the approval of such drug4 7h7 ,sunset ,the authority of the ,secretary to carry out the generic priority review voucher program under this section shall terminate on ,october #a1 #bjbb4 4 #bjb4 ,tropical disease product application ,section #ebd7;a77#d77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfjn7a77#d77;,a77 is amended-- 7#a7 in clause 7i71 by striking and2 7#b7 in clause 7ii71 by adding and after the semicolon2 and 7#c7 by adding at the end the following3 7iii7 that contains reports of new clinical investigations 7other than bioavailability studies7 essential to the approval of the application and conducted or sponsored by the applicant2 4 ,,iii ,study on ,,rems #cja4 ,study on ,,rems 7a7 ,in general ,the ,comptroller ,general shall conduct a review of the implementation and effectiveness of section #eje-a of the ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 7referred to in this section as the ,,rems program71 which section-- 7#a7 authorizes the ,secretary of ,health and ,human ,services to require a risk evaluation and mitigation strategy 7referred to in this section as ,,rems72 and 7#b7 codifies and expands regulations issued by the ,food and ,drug ,administration under which the ,food and ,drug ,administration may impose restrictions on distribution necessary to ensure a drug is safely used4 7b7 ,contents of study ,in conducting the review under subsection 7a71 the ,comptroller ,general shall examine each relevant element described in subsection 7c7 with respect to each of the following categories3 7#a7 ,new drug applications under subsection 7b7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b774 7#b7 ,abbreviated new drug applications under subsection 7j7 of such section4 7#c7 ,applications for the license of a biological product under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7#d7 ,single1 shared system ,,rems1 as described in section #eje-a7;i7 of the ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;i774 7#e7 ,controlled substances as defined in section #ajb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hjb74 7#f7 ,r,i,s,k,m,a,ps or other risk management processes employed by the ,food and ,drug ,administration4 7c7 ,elements under review ,in conducting the review under subsection 7a71 the ,comptroller ,general shall examine each of the following elements with respect to each relevant category described in subsection 7b74 7#a7 ,for each type of application1 and by year1 the number of ,,rems required1 submitted1 voluntarily submitted1 modified1 added1 approved1 or removed1 and whether those ,,rems included elements to assure safe use1 such as restricted distribution4 7#b7 ,for each type of application1 the number of ,,rems in effect at the time of the review and the number of years that each such ,,rems has been in effect at such time4 7#c7 ,if and how the ,,rems program has improved drug safety1 as compared to the time before the ,,rems program became effective1 and how the ,food and ,drug ,administration tracks such improvements4 7#d7 ,the burdens associated with ,,rems1 including burdens on patients1 health care providers1 generic drug manufacturers1 and brand drug manufacturers4 7#e7 ,in the case of a ,,rems program for a drug containing a controlled substance1 the coordination between the ,food and ,drug ,administration and the ,drug ,enforcement ,administration4 7#f7 ,the impact of additional risk mitigation strategies1 including non-,,rems restricted distribution systems1 imposed by companies outside of what is required under the ,,rems program4 7#g7 ,the standards and policies applied by the ,food and ,drug ,administration to require1 modify1 add1 or remove1 a ,,rems1 and how those standards and policies have changed since the ,,rems program became effective4 7d7 ,report ,not later than ,may #a1 #bjah1 the ,comptroller ,general shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 the ,special ,committee on ,aging of the ,senate1 and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 containing the results of the review described in this section4