,,ii #aaith ,,congress #ast ,session ,s4 #bbi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #bc1 #bjbe,mr4 ,durbin 7for himself1 ,mr4 ,grassley1 ,mr4 ,king1 ,ms4 ,ernst1 ,ms4 ,smith1 ,mr4 ,welch1 ,mr4 ,blumenthal1 ,ms4 ,baldwin1 and ,mr4 ,tuberville7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xi of the ,social ,security ,act to require that direct-to-consumer advertisements for prescription drugs and biological products include an appropriate disclosure of pricing information4 #a4 ,short title ,this ,act may be cited as the ,drug-price ,transparency for ,consumers ,act of #bjbe or the ,,dtc ,act of #bjbe4 #b4 ,findings2 sense of the ,senate 7a7 ,findings ,congress finds the following3 7#a7 ,direct-to-consumer advertising of prescription pharmaceuticals is legally permitted in only #b developed countries1 the ,united ,states and ,new ,zealand4 7#b7 ,in #bjah1 pharmaceutical ad spending exceeded #f1jdf1jjj1jjj1 a #d4h-percent increase over #bjag1 resulting in the average ,american seeing #i drug advertisements per day4 7#c7 ,the most commonly advertised medication in the ,united ,states in #bjbj had a list price of more than #f1jjj for a one-month supply4 7#d7 ,a #bjba ,government ,accountability ,office report found that two-thirds of all direct-to-consumer drug advertising between #bjaf and #bjah was concentrated among #ci brand-name drugs or biologicals1 about half of which were recently approved by the ,food and ,drug ,administration4 7#e7 ,according to a #bjaa ,congressional ,budget ,office report1 pharmaceutical manufacturers advertise their products directly to consumers in an attempt to boost demand for their products and thereby raise the price that consumers are willing to pay1 increase the quantity of drugs sold1 or achieve some combination of the two4 7#f7 ,studies1 including a #bjab systematic review published in the ,annual ,review of ,public ,health1 a #bjje randomized trial published in the ,journal of the ,american ,medical ,association1 and a #bjjd survey published in ,health ,affairs1 show that patients are more likely to ask their doctor for a specific medication1 and the doctor is more likely to write a prescription for it1 if a patient has seen an advertisement for such medication1 even if such medication is not the most clinically appropriate for the patient or if a lower cost generic medication may be available4 7#g7 ,according to a #bjaa ,congressional ,budget ,office report1 the average number of prescriptions written for newly approved brand-name drugs with direct-to-consumer advertising was #i times greater than the average number of prescriptions written for newly approved brand-name drugs without direct-to-consumer advertising4 7#h7 ,the ,centers for ,medicare ,medicaid ,services is the single largest drug payer in the ,united ,states4 ,between #bjaf and #bjah1 #eh percent of the #efj1jjj1jjj1jjj in ,medicare drug spending was for advertised drugs1 and in #bjah alone1 the #bj most advertised drugs on television cost ,medicare and ,medicaid a combined #cd1jjj1jjj1jjj4 7#i7 ,a #bjba ,government ,accountability ,office report found that direct-to-consumer advertising may have contributed to increases in ,medicare beneficiary use and spending among certain drugs4 7#aj7 ,the ,american ,medical ,association has passed resolutions supporting the requirement for price transparency in any direct-to-consumer advertising1 stating that such advertisements on their own inflate demand for new and more expensive drugs1 even when these drugs may not be appropriate4 7#aa7 ,a #bjai study published in the ,journal of the ,american ,medical ,association found that health care consumers dramatically underestimate their out-of-pocket costs for certain expensive medications1 but once they learn the wholesale acquisition cost 7in this section referred to as the ,,wac7 of the product1 they are far better able to approximate their out-of-pocket costs4 7#ab7 ,approximately half of ,americans have high-deductible health plans1 under which they often pay the list price of a drug until their insurance deductible is met4 ,all of the top ,medicare prescription drug plans use coinsurance rather than fixed-dollar copayments for medications on nonpreferred drug tiers1 exposing beneficiaries to ,,wac prices4 7#ac7 ,section #aai of division ,,cc of the ,consolidated ,appropriations ,act1 #bjba 7,public ,law #aaf-bfj7 requires the ,secretary of ,health and ,human ,services to increase the use of real-time benefit tools to lower beneficiary costs4 ,however1 there still remains a lack of available pricing tools1 so patients may not learn of their medication's cost until after being given a prescription for the medication4 ,a #bjac study published in ,the ,oncologist found that one-quarter of all cancer patients chose not to fill a prescription due to cost4 7#ad7 ,the ,federal ,government already exercises its authority to oversee certain aspects of direct-to-consumer drug advertising1 including required disclosures of information related to side effects1 contraindications1 and effectiveness4 7b7 ,sense of ,congress ,it is the sense of ,congress that-- 7#a7 a lack of transparency in pricing for pharmaceuticals has led to a lack of competition for such pharmaceuticals1 as evidenced by a finding by the ,department of ,health and ,human ,services that ,consumers of pharmaceuticals are currently missing information that consumers of other products can more readily access1 namely the list price of the product1 which acts as a point of comparison when judging the reasonableness of prices offered for potential substitute products 7#hd ,fed4 ,reg4 #bjgce72 7#b7 in an age where price information is ubiquitous1 the prices of pharmaceuticals remain shrouded in secrecy and limited to those who subscribe to expensive drug price reporting services1 which typically include pharmaceutical manufacturers or other health care industry entities and not the general public2 7#c7 greater insight and transparency into drug prices will help consumers know if they can afford to complete a course of therapy before deciding to initiate that course of therapy2 7#d7 price shopping is the mark of rational economic behavior1 and markets operate more efficiently when consumers have relevant information about a product1 including its price1 before making an informed decision about whether to buy that product2 7#e7 providing consumers with basic price information may result in the selection of lesser cost alternatives1 all else being equal relative to the patient's care1 and is integral to providing adequate competition in the market2 7#f7 the ,,wac is a factual1 objective1 and uncontroversial definition for the list price of a medication1 in that it is defined in statute1 reflects an understood place in the supply chain1 and is at the sole discretion of the manufacturer to set2 7#g7 there is a governmental interest in ensuring that consumers who seek to purchase pharmaceuticals for purposes of promoting their health and safety understand the objective list price of any pharmaceutical that they are encouraged through advertisements to purchase1 which allows consumers to make informed purchasing decisions2 and 7#h7 there is a governmental interest in mitigating wasteful expenditures and promoting the efficient administration of the ,medicare program by slowing the growth of ,federal spending on prescription drugs4 #c4 ,requirement that direct-to-consumer advertisements for prescription drugs and biological products include an appropriate disclosure of pricing information ,part ,a of title ,,xi of the ,social ,security ,act is amended by adding at the end the following new section3 #aaej;,d4 ,requirement that direct-to-consumer advertisements for prescription drugs and biologicals include an appropriate disclosure of pricing information 7a7 ,requirement 7#a7 ,in general ,subject to paragraph 7#b71 not later than ,july #a1 #bjbf1 the ,secretary shall require that each direct-to-consumer advertisement for a prescription drug or biological product for which payment is available under title ,,xviii or ,,xix and that is required to include the information relating to side effects1 contraindications1 and effectiveness described in section #bjb4a7;e77#a7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation7 also include an appropriate disclosure of pricing information1 as described in subsection 7b71 with respect to such prescription drug or biological product4 7#b7 ,exemption ,the requirement under paragraph 7#a7 shall not apply to a prescription drug or biological product for which the wholesale acquisition cost for a #cj-;day supply of 7or1 if applicable1 a typical course of treatment as set forth in the approved label for the primary indication addressed in the advertisement for7 such prescription drug or biological product is less than #ce4 7b7 ,appropriate disclosure of pricing information ,for the purposes of subsection 7a71 an appropriate disclosure of pricing information1 with respect to a prescription drug or biological product-- 7#a7 shall clearly and conspicuously disclose the wholesale acquisition cost for a #cj-;day supply of 7or1 if applicable1 a typical course of treatment for7 such prescription drug or biological product2 and 7#b7 may explain that a consumer may pay a different amount for such prescription drug or biological product than such wholesale acquisition cost depending on the health insurance coverage of the consumer4 7c7 ,rulemaking ,not later than #a year after the date of enactment of this section1 the ,secretary shall promulgate final regulations to carry out this section1 including establishing requirements for-- 7#a7 the visual and audio components1 with respect to each medium of direct-to-consumer advertisement1 to communicate the wholesale acquisition cost of the advertised prescription drug or biological product2 and 7#b7 the amount of time for a manufacturer to update any direct-to-consumer advertisement to reflect any change to the wholesale acquisition cost of the advertised prescription drug or biological product4 7d7 ,sanctions ,any manufacturer of a prescription drug or biological product1 or an agent of such manufacturer1 that violates the requirement of this section may be subject to a civil money penalty of not more than #ajj1jjj for each such violation4 ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to civil money penalties under the preceding sentence in the same manner as they apply to a penalty or proceeding under section #aabh;,a7a74 7e7 ,public reporting ,in order to enforce the requirement under this section1 the ,secretary may use information reported about manufacturers that fail to comply with such requirement4 7f7 ,definitions ,in this section3 7#a7 ,biological product ,the term biological product means any biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act7 that is licensed by the ,food and ,drug ,administration pursuant to section #cea and is subject to the requirements of section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7#b7 ,prescription drug ,the term prescription drug means any drug 7as defined in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 that has been approved by the ,food and ,drug ,administration pursuant to section #eje of such ,act and is subject to the requirements of section #ejc7;b77#a7 of such ,act4 7#c7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b74 7g7 ,authorization of appropriations ,there are authorized to be appropriated such sums as may be necessary for the purposes of carrying out this section4 4