,i #aagth ,,congress #b;d ,session ,h4 ,r4 #fifc ,,in ,,the ,,house ,,of ,,representatives ,march #g1 #bjbb,mr4 ,pallone introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to strengthen requirements for postapproval studies for drugs approved using accelerated approval1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,accelerated ,approval ,integrity ,act of #bjbb4 #b4 ,postapproval studies required for accelerated approval drugs 7a7 ,in general ,section #ejf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;c77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in the matter preceding subparagraph 7,a71 by striking may be subject to #a or both of and inserting shall be subject to2 7,b7 by amending subparagraph 7,a7 to read as follows3 7,a7 ,postapproval studies 7i7 ,in general ,the sponsor of a product approved under accelerated approval shall-- 7,i7 conduct appropriate1 adequate1 and well-controlled postapproval studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit2 and 7,,ii7 submit reports on such studies in accordance with section #ejf;,b4 7ii7 ,agreement ,the ,secretary and the sponsor shall enter into an agreement regarding the required conduct of such studies prior to the ,secretary approving a product under accelerated approval4 ,such agreement may include requirements regarding enrollment targets1 study protocol1 and milestones1 including the target date of study completion4 7iii7 ,studies begun before approval ,the ,secretary may-- 7,i7 require such studies to be underway prior to approval2 and 7,,ii7 refuse to approve a product under accelerated approval until such studies are underway4 2 and 7,c7 in subparagraph 7,b71 by striking 7,b7 ,that the sponsor and inserting the following3 7,b7 ,promotional materials ,the sponsor of a product approved under accelerated approval shall 2 and 7#b7 by striking paragraph 7#c7 and inserting the following3 7#c7 ,expedited withdrawal of approval 7,a7 ,in general ,the ,secretary may withdraw approval of a product approved under accelerated approval using expedited procedures described in subparagraph 7,b71 if-- 7i7 the sponsor fails to conduct any required postapproval study of the product with due diligence2 7ii7 the sponsor fails to achieve agreed upon enrollment targets1 milestones1 or timely study completion2 7iii7 the sponsor fails to submit reports in accordance with section #ejf;,b2 7iv7 a study required to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit of the product fails to verify and describe such effect or benefit2 7v7 other evidence demonstrates that the product is not shown to be safe or effective under the conditions of use2 or 7vi7 the sponsor disseminates false or misleading promotional materials with respect to the product4 7,b7 ,expedited procedures described ,expedited procedures described in this subparagraph-- 7i7 shall consist of-- 7,i7 providing the sponsor due notice and an opportunity for written appeal to the ,commissioner of ,food and ,drugs2 and 7,,ii7 an opportunity for public comment on the notice proposing to withdraw approval2 and 7ii7 may include1 at the ,secretary's discretion1 convening and consulting an advisory committee4 7,c7 ,automatic expiration ,the approval of a product approved under accelerated approval after the date of enactment of the ,accelerated ,approval ,integrity ,act of #bjbb shall automatically expire #a year after any target date of study completion included in an agreement described in clause 7ii7 of paragraph 7#b77;,a71 and in no case later than #e years after the date on which the product is approved1 unless-- 7i7 a study required to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical benefit of the product has verified that predicted effect2 or 7ii7 the ,secretary has determined that adequate progress has been made on completion of postapproval studies required under paragraph 7#b77;,a74 7#d7 ,labeling 7,a7 ,in general ,subject to subparagraph 7,b71 the label for a product approved under accelerated approval shall include-- 7i7 a statement indicating that the product was approved under accelerated approval2 7ii7 a statement indicating that continued approval of the product is subject to postmarketing studies to verify clinical benefit2 7iii7 identification of the clinical endpoint that is under study and any known limitations of that surrogate or intermediate endpoint in determining clinical benefit2 7iv7 a succinct description of the product and any uncertainty about anticipated clinical benefit and a discussion of available evidence with respect to such clinical benefit2 and 7v7 any other information required by the ,secretary in the order approving the product4 7,b7 ,applicability ,the labeling requirements of subparagraph 7,a7 shall apply only to products approved under accelerated approval for which the predicted effect on irreversible morbidity or mortality or other clinical benefit has not been verified4 4 7b7 ,reports of postmarketing studies ,section #ejf;,b7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;b7a77 is amended-- 7#a7 by redesignating paragraph 7#b7 as paragraph 7#c72 and 7#b7 by inserting after paragraph 7#a7 the following3 7#b7 ,accelerated approval ,notwithstanding paragraph 7#a71 a sponsor of a drug approved under accelerated approval shall submit to the ,secretary a report of the progress of any study required under section #ejf7;c71 including progress toward any agreed upon enrollment targets1 milestones1 and other information as required by the ,secretary1 not later than #ij days after the approval of such drug and not less frequently than every #ij days thereafter1 until the study is completed or terminated4 4 7c7 ,enforcement ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cca7 is amended by inserting after paragraph 7eee7 the following3 7fff7 ,the failure of a sponsor of a product approved under accelerated approval pursuant to section #ejf7;c7-- 7#a7 to conduct with due diligence any postapproval study required under section #ejf7;c7 with respect to such product2 or 7#b7 to submit timely reports with respect to such product in accordance with section #ejf;,b7a77#b74 4