,,ii #aaith ,,congress #b;d ,session ,s4 #dcee ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #ba1 #bjbf,mr4 ,wyden 7for himself1 ,mr4 ,welch1 ,ms4 ,warren1 ,mr4 ,gallego1 ,mr4 ,merkley1 ,mr4 ,lujn1 ,ms4 ,baldwin1 ,mr4 ,whitehouse1 ,mr4 ,kelly1 ,mr4 ,sanders1 ,mr4 ,warner1 ,ms4 ,smith1 ,ms4 ,hassan1 ,ms4 ,cortez ,masto1 ,mr4 ,bennet1 ,mr4 ,warnock1 ,ms4 ,hirono1 and ,ms4 ,cantwell7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to require the ,department of ,health and ,human ,services to release documents1 communications1 and other information relating to most favored nation pricing agreements and other private or confidential drug pricing deals struck with manufacturers1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,drug ,deal ,disclosure ,act4 #b4 ,release of information relating to most-favored-nation pricing agreements 7a7 ,public release of information 7#a7 ,in general ,not later than #cj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this ,act as the ,secretary71 subject to subsections 7b7 and 7c71 shall make publicly available in a centralized1 searchable1 and downloadable format all records1 documents1 communications1 meeting notes1 memoranda1 directives1 logs1 metadata1 contracts1 and agreements as provided by the ,department of ,health and ,human ,services1 or any other ,federal department1 agency1 or office that possesses such information to which the ,secretary does not have direct access1 that relate to any agreement1 including any agreement described in paragraph 7#b7 or 7#c71 between an ,executive ,office of the ,president1 the ,department of ,health and ,human ,services1 the ,department of ,commerce1 or another ,federal department1 agency1 or office and any drug manufacturer entered into on or after ,january #bj1 #bjbe1 that includes any of the following provisions3 7,a7 ,that the manufacturer or any of its subsidiaries shall offer reduced prices on any of its drugs to levels that make reference to the prices paid for drugs in nations other than the ,united ,states1 including under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 and the ,medicaid program under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq474 7,b7 ,that the manufacturer or any of its subsidiaries shall offer or expand its offerings of direct-to-consumer drug sales or discounts on its drugs through the website of such manufacturer or subsidiary1 partnerships with other entities1 or any government-sponsored platform1 including ,trump,rx4 7,c7 ,that goods imported or produced by the manufacturer or any of its subsidiaries shall be excluded or exempt from any duties or other import restrictions4 7,d7 ,that the manufacturer or any of its subsidiaries shall further invest money or resources into the ,united ,states or repatriate revenue made in nations other than the ,united ,states4 7,e7 ,that the manufacturer or any of its subsidiaries shall receive special treatment1 such as an exemption from1 or specialized predetermined conditions of participation for1 any demonstration project proposed or implemented by the ,center for ,medicare and ,medicaid ,innovation1 including the ,global ,benchmark for ,efficient ,drug ,pricing ,,globe ,model1 and the ,guarding ,u4,s4 ,medicare ,against ,rising ,drug ,costs ,,guard ,model4 7,f7 ,that the manufacturer or any of its subsidiaries shall contribute to1 or be guaranteed purchasing agreement for1 the ,strategic ,national ,stockpile established under section #cai;,f-#b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;b74 7,g7 ,that the manufacturer or any of its subsidiaries shall receive a ,commissioner's ,national ,priority ,review ,voucher through the pilot program of the ,food and ,drug ,administration4 7#b7 ,agreements ,the agreements described in this paragraph1 and for which public disclosure is required under paragraph 7#a71 include the agreements publicly announced by an ,executive ,office of the ,president or the applicable drug manufacturer1 as follows3 7,a7 ,abb,vie ,inc4 on ,january #ab1 #bjbf4 7,b7 ,amgen ,inc4 on ,december #ai1 #bjbe4 7,c7 ,astra,zeneca plc4 on ,october #aj1 #bjbe4 7,d7 ,boehringer ,ingelheim ,pharmaceuticals1 ,inc4 on ,december #ai1 #bjbe4 7,e7 ,bristol ,myers ,squibb on ,december #ai1 #bjbe4 7,f7 ,eli ,lilly ,company on ,november #f1 #bjbe4 7,g7 ,,emd ,serono ,inc4 on ,october #af1 #bjbe4 7,h7 ,genentech1 ,inc4 on ,december #ai1 #bjbe4 7,i7 ,gilead ,sciences1 ,inc4 on ,december #ai1 #bjbe4 7,j7 ,,gsk plc4 on ,december #ai1 #bjbe4 7,k7 ,johnson ,johnson1 ,inc4 on ,january #h1 #bjbf4 7,l7 ,merck ,co41 ,inc4 on ,december #ai1 #bjbe4 7,m7 ,novartis ,,ag on ,december #ai1 #bjbe4 7,n7 ,novo ,nordisk ,inc4 on ,november #f1 #bjbe4 7,o7 ,pfizer ,inc4 on ,september #cj1 #bjbe4 7,p7 ,sanofi ,s4,a4 on ,december #ai1 #bjbe4 7#c7 ,subsequent agreements ,if1 after the date of enactment of this ,act1 an ,executive ,office of the ,president or any other ,federal department1 agency1 or office enters into an agreement with a drug manufacturer or any of its subsidiaries that meets the criteria described in paragraph 7#a71 or modifies or amends an agreement listed in paragraph 7#b71 not later than #cj days after the date of ratification of such new agreement1 the ,secretary shall disclose information about such agreement as described in paragraph 7#a74 7b7 ,prohibited grounds for withholding ,no record shall be withheld1 delayed1 or redacted on the basis of reputational harm or political sensitivity1 including to any government official1 public figure1 or manufacturer4 7c7 ,permitted withholdings ,the ,secretary may withhold or redact the segregable portions of agreements required to be disclosed under subsection 7a77#a7 that include proprietary pricing information1 pricing information that manufacturers are legally prohibited from disclosing based on the law of a nation other than the ,united ,states or as part of a settlement agreement or court directive1 or information that is protected from disclosure under other applicable law1 provided that the ,secretary-- 7#a7 discloses whether the ,secretary has been provided access to confidential pricing information by each individual manufacturer2 and 7#b7 includes with any such redaction or withholding a written justification1 and ensures that such written justification is published in the ,federal ,register and submitted to ,congress4 #c4 ,report to ,congress ,not later than #ae days after the completion of the release of agreements listed under section #b7;a77#b71 the ,secretary shall submit to the ,committee on ,finance and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce1 the ,committee on ,education and ,workforce1 and the ,committee on ,ways and ,means of the ,house of ,representatives a report listing-- 7#a7 all documents and information released and withheld2 and 7#b7 a summary of redactions and withholdings made1 including legal basis for such redactions and withholdings4 #d4 ,congressional ,budget ,office and ,government ,accountability ,office analysis ,not later than #ij days after the completion of the release of agreements listed under section #b7;a77#b71 the ,director of the ,congressional ,budget ,office and the ,comptroller ,general of the ,united ,states1 jointly1 shall publish a report on the economic and budgetary effects of all agreements disclosed under section #b1 including-- 7#a7 the expected economic and budgetary consequences of each such agreement2 7#b7 an analysis of direct cost savings that individuals in the ,united ,states have received and can expect to receive1 by insurance status1 including uninsured individuals1 as a consequence of the agreements2 7#c7 a budget analysis of the impacts of the agreements on the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq471 the ,medicaid program under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq471 and qualified health plans offered through the ,american ,health ,benefit ,exchanges established under section #acaa or #acba of the ,patient ,protection and ,affordable ,care ,act 7#db ,u4,s4,c4 #ahjca2 #ahjda72 and 7#d7 any impact1 or expected impact1 on-- 7,a7 drug price competition 7such as through shifts from the use of generic drugs to brand name drugs72 7,b7 section #aabh;,b of the ,social ,security ,act 7commonly referred to as the ,federal ,anti-,kickback ,statute 7#db ,u4,s4,c4 #acbj;a-#g;b772 and 7,c7 health plan formulary design 7such as cost shifting1 adverse events for health plans1 and spending acceleration74