,i #aafth ,,congress #ast ,session ,h4 ,r4 #daeh ,,in ,,the ,,house ,,of ,,representatives ,august #b1 #bjai,ms4 ,pingree introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to prohibit price gouging in the sale of drugs4 #a4 ,short title ,this ,act may be cited as the ,combatting ,unreasonable ,rises and ,excessively ,high ,drug ,prices ,act or the ,,cure ,high ,drug ,prices ,act4 #b4 ,definitions ,in this ,act3 7#a7 ,average manufacturer price ,the term average manufacturer price-- 7,a7 has the meaning given the term in section #aibg7k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k772 or 7,b7 with respect to a drug for which there is no average manufacturer price as so defined1 means the wholesale acquisition cost of the drug4 7#b7 ,drug ,the term drug-- 7,a7 has the meaning given the term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 and 7,b7 includes biological products1 as defined in section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 7#c7 ,federal health care program ,the term ,federal health care program has the meaning given the term in section #aabh;,b7f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7f774 7#d7 ,manufacturer ,the term manufacturer means a person-- 7,a7 that holds the application for a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or the license issued under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 or 7,b7 who is responsible for setting the price for the drug4 7#e7 ,price gouging ,the term price gouging means an increase in the average manufacturer price of a qualifying drug that-- 7,a7 is in substantial excess of an amount that could be reasonably justified by an increase in cost of producing the drug or by an increase in cost due to appropriate expansion of access to the drug to promote public health2 and 7,b7 because of insufficient competition in the marketplace1 consumers cannot reasonably avoid4 7#f7 ,qualifying drug ,the term qualifying drug means any drug1 including a combination product whose primary mode of action is determined under section #ejc7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;g77 to be that of a drug1 that-- 7,a7 is subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a772 and 7,b7 is covered by a ,federal health care program4 7#g7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 #c4 ,price gouging prohibited 7a7 ,in general ,a manufacturer shall not engage in price gouging in the sale of a qualifying drug4 7b7 ,presumption ,price gouging shall be presumed if the average manufacturer price has increased-- 7#a7 #aj percent or more within the previous #ab-month period2 7#b7 #bj percent or more in the previous #cf-month period2 or 7#c7 #cj percent or more within the previous #fj-month period4 7c7 ,notice by ,secretary ,the ,secretary shall notify the manufacturer of an increase1 within the previous #b years1 in the average manufacturer price of a qualifying drug the ,secretary has reason to believe constitutes price gouging1 by sending notice to the manufacturer1 requesting a statement of justification for the increase1 which may include-- 7#a7 itemizing the components of the cost of producing the qualifying drug2 7#b7 identifying the circumstances and timing of an increase in materials or manufacturing costs that caused an increase in the average manufacturer price of the qualifying drug within the #e-year period preceding the date of the average manufacturer price increase2 7#c7 identifying the circumstances and timing of any expenditures made by the manufacturer to expand access to the qualifying drug and explaining any improvement in public health associated with those expenditures2 7#d7 providing sales and price information for other qualifying drugs with similar therapeutic effects1 as relevant to assessing the extent of competition in the marketplace1 and the choice available to consumers2 and 7#e7 providing any other information that the manufacturer believes to be relevant to a determination of whether a violation of this ,act has occurred4 7d7 ,statement ,not later than #de days after the date on which a manufacturer receives a statement under subsection 7c71 the manufacturer shall submit to the ,secretary a statement described in subsection 7c74 7e7 ,determination by ,secretary ,if the ,secretary determines1 after review of the statement of justification1 or based on reasonable belief if the manufacturer fails to submit a statement of justification as required1 that the manufacturer has engaged in price gouging with respect to a qualifying drug1 the ,secretary shall notify the manufacturer of the determination4 7f7 ,remedy 7#a7 ,in general ,the ,secretary may order that a manufacturer determined under subsection 7e7 to have engaged in price gouging with respect to a qualifying drug-- 7,a7 restore to any consumer1 including a third-party payor1 any excessive amount paid as a result of a price increase that violates this ,act2 7,b7 make the drug available to participants of any qualified health plan or ,federal health plan for a period of up to #a year at the price at which the drug was made available to consumers immediately before the violation of this ,act2 or 7,c7 if the price gouging is done knowingly1 or occurs after a previous determination by the ,secretary or price gouging by the manufacturer1 pay a civil penalty of up to #c times the excessive amount the manufacturer received as a result of a violation of this ,act4 7#b7 ,appeals ,any person adversely affected by a determination of the ,secretary under this subsection may obtain review of the determination in accordance with section #aabh;,a7e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7e774 7g7 ,enforcement by ,attorney ,general 7#a7 ,in general ,if a manufacturer determined under subsection 7e7 to have engaged in price gouging fails to comply with an order of the ,secretary under subsection 7f71 the ,secretary may refer the matter to the ,attorney ,general for enforcement4 7#b7 ,subpoenas ,the ,attorney ,general may subpoena documents or testimony as may assist in establishing whether the manufacturer engaged in price gouging in violation of this ,act4 7#c7 ,action ,the ,attorney ,general may bring an action in an appropriate district court for relief1 including any relief described in subsection 7f7 and such further relief as the court determines is appropriate4 #d4 ,effective date2 applicability ,this ,act shall-- 7#a7 take effect on ,january #a1 #bjai2 and 7#b7 apply with respect to all increases in the average manufacturer price of a qualifying drug occurring on or after that date4