,,ii #aaeth ,,congress #ast ,session ,s4 #baeg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,november #af1 #bjag ,mr4 ,durbin 7for himself1 ,mr4 ,king1 ,mr4 ,brown1 ,mr4 ,franken1 ,ms4 ,hassan1 and ,ms4 ,harris7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to require drug manufacturers to disclose the prices of prescription drugs in any direct-to-consumer advertising and marketing to practitioners of a drug4 #a4 ,short title ,this ,act may be cited as the ,drug-,price ,transparency in ,communications ,act4 #b4 ,findings ,congress finds as follows3 7#a7 ,direct-to-consumer advertising of prescription pharmaceuticals is legal in only #b developed countries1 the ,united ,states and ,new ,zealand4 7#b7 ,direct-to-consumer advertising of prescription pharmaceuticals is designed to cause patients to pressure physicians to prescribe certain medications4 7#c7 ,in #bjae1 pharmaceutical companies spent more than #ajj1jjj1jjj on advertising with respect to each of #af brand-name drugs1 primarily new and expensive drugs4 7#d7 ,prescription rates of medications advertised directly to consumers have increased by #cd4b percent compared to a #e4a percent increase in other pharmaceuticals4 7#e7 ,prescription pharmaceuticals cost more in the ,united ,states than they do in any other country4 7#f7 ,the ,american ,medical ,association has passed resolutions calling for the ban of direct-to-consumer advertising of prescription pharmaceuticals1 and to require price transparency in any direct-to-consumer advertising4 7#g7 ,the amount of spending by pharmaceutical companies in marketing to health care providers is more than #d times the spending for direct-to-consumer advertising4 7#h7 ,health care providers are more likely to prescribe a certain drug if they have received payments or marketing materials from the manufacturer of that drug4 #c4 ,price disclosure requirement for direct-to-consumer drug advertisements 7a7 ,in general ,section #cjc7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;g77#a77 is amended-- 7#a7 by striking 7,a7 and inserting 7i72 7#b7 by striking 7,b7 and inserting 7ii72 7#c7 by striking 7#a7 ,with respect and inserting 7#a77;,a7 ,with respect2 7#d7 by striking this paragraph each place it appears and inserting this subparagraph2 7#e7 by striking ,no other civil monetary penalties in this ,act 7including the civil penalty in section #cjc7;f77#d77 and inserting ,no civil monetary penalties 7including the civil penalty in section #cjc7;f77#d771 other than the penalties under this subparagraph and subparagraph 7,b72 and 7#f7 by adding at the end the following3 7,b7 ,with respect to a person who is a holder of an approved application under section #eje for a drug subject to section #ejc7;b7 or under section #cea of the ,public ,health ,service ,act1 any such person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that does not include the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act7 for a #cj-;day supply of the drug shall be liable to the ,united ,states for a civil penalty in an amount not to exceed #a1jjj1jjj for the first such violation in any #c-year period1 and not to exceed #e1jjj1jjj for each subsequent violation in any #c-year period4 ,for purposes of this subparagraph1 all violations under this paragraph occurring in a single day shall be considered one violation4 ,with respect to advertisements that appear in magazines or other publications that are published less frequently than daily1 each issue date 7whether weekly or monthly7 shall be treated as a single day for the purpose of calculating the number of violations under this subparagraph4 4 7b7 ,transfer of funds ,for each fiscal year1 there are authorized to be appropriated1 and are appropriated1 out of any funds not otherwise obligated1 to the ,director of the ,national ,institutes of ,health for purposes of carrying out medical research1 an amount equal to the amount collected in penalties during the previous fiscal year for violations of section #cjc7;g77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7c7 ,regulations ,the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall promulgate regulations to carry out subparagraph 7,b7 of section #cjc7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7;g77#a771 as added by subsection 7a74 ,such regulations shall include provisions setting forth-- 7#a7 a reasonable amount of time a manufacturer has to update any direct-to-consumer advertising of a drug in accordance with such subparagraph 7,b7 after a change to the wholesale acquisition cost of the drug2 and 7#b7 the specific manner in which the wholesale acquisition cost of a drug is required to be conspicuously disclosed in such direct-to-consumer advertisements in order to communicate such single price metric to the public1 which shall include visual and audio 7as applicable7 components of the advertisement1 and which may include a brief qualitative explanation of reduced cost availability for certain consumers1 such as through insurance cost-sharing arrangements or patient assistance programs4 #d4 ,drug manufacturer duty to disclose drug prices to practitioners 7a7 ,duty ,to disclose ,whenever a drug manufacturer1 including any representative of the manufacturer1 communicates with a health care practitioner about a drug manufactured by the drug manufacturer1 including through promotional1 educational1 or marketing communications1 meetings or paid events1 and the provision of goods1 gifts1 and samples1 the drug manufacturer shall disclose to the practitioner the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b777 for a #cj-;day supply of the drug1 which may include a brief qualitative explanation of reduced cost availability for certain consumers that is consistent with the regulations described in section #c7;c77#b74 7b7 ,enforcement by ,federal ,trade ,commission 7#a7 ,unfair or deceptive acts or practices ,a violation of subsection 7a7 by a person with respect to whom the ,commission is empowered under section #e7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#b77 shall be treated as a violation of a rule defining an unfair or deceptive act or practice prescribed under section #ah7;a77#a77;,b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #eg;a7a77#a77;,b774 7#b7 ,powers of ,federal ,trade ,commission 7,a7 ,in general ,the ,federal ,trade ,commission shall enforce this section in the same manner1 by the same means1 and with the same jurisdiction1 powers1 and duties as though all applicable terms and provisions of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 were incorporated into and made a part of this ,act4 7,b7 ,privileges and immunities ,any person who violates this section shall be subject to the penalties and entitled to the privileges and immunities provided in the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq474 7c7 ,rulemaking ,the ,federal ,trade ,commission shall promulgate in accordance with section #eec of title #e1 ,united ,states ,code1 such rules as may be necessary to carry out this section4 7d7 ,savings provision ,nothing in this section shall be construed to limit1 impair1 or supersede the operation of the ,federal ,trade ,commission ,act or any other provision of ,federal law4