,i #aaith ,,congress #b;d ,session ,h4 ,r4 #ijdj ,,in ,,the ,,house ,,of ,,representatives ,may #bf1 #bjbf,mr4 ,sherman introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on the ,judiciary1 and ,financial ,services1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to establish fair prices for prescription drugs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,regulate the ,price of ,all ,drugs ,act4 #b4 ,establishing the ,prescription ,drug ,regulatory ,commission 7a7 ,in general ,there is established the ,prescription ,drug ,price ,regulatory ,commission 7in this section referred to as the ,commission74 7b7 ,duties of ,commission 7#a7 ,in general ,not later than the fair price recommendation date with respect to a fair price applicability year1 the ,commission shall1 with respect to each approved prescription drug1 submit to the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 a recommendation regarding the price that the ,commission determines to be a fair price for such drug in order for the manufacturer of such drug to provide access to such price-- 7,a7 to any fair price eligible individual who is dispensed such drug during such fair price applicability year 7and to pharmacies1 mail order services1 and other dispensers1 with respect to such individuals who are dispensed such drugs72 and 7,b7 to any hospital1 physician1 or other provider of services or supplier that furnishes or administers such drug to such an individual during such year4 7#b7 ,fair price revisions and waivers ,at any time during a fair price applicability year1 the ,commission may submit to the ,secretary a recommendation-- 7,a7 that the ,secretary revise the fair price established for an approved prescription drug for such year under section #c7;b72 or 7,b7 that the ,secretary authorize a temporary waiver of such fair price under section #c7;c74 7#c7 ,required factors for consideration ,in making a recommendation under paragraph 7#a7 with respect to the fair price of an approved prescription drug1 or a recommendation under paragraph 7#b7 with respect to a revision or waiver of such fair price1 the ,commission shall take into account the following factors with respect to such drug3 7,a7 ,the costs to the manufacturer of producing and distributing of such drug4 7,b7 ,the cost-effectiveness of the drug and its therapeutic benefit 7which may be determined on the basis of quality-adjusted life years1 equal value of life years gained1 or such other measure as the ,commission may specify74 7,c7 ,the anticipated demand for the drug during the fair price applicability year4 7,d7 ,the costs and risks to the manufacturer involved in researching and developing such drug1 and the return on investment that would provide adequate incentive to the manufacturer to continue research4 7,e7 ,in the case that such drug is available for purchase in #a or more comparable reference countries1 the average price of such drug in such country4 7,f7 ,such other factors as the ,secretary of ,health and ,human ,services may specify through rulemaking4 7c7 ,members of ,commission 7#a7 ,in general ,the ,commission shall be composed of #ac members as follows3 7,a7 ,seven members appointed by the ,president from individuals who are not officers or employees of any government4 7,b7 ,six ex officio members appointed by the ,secretary of ,health and ,human ,services from each of the following agencies3 7i7 ,the ,veterans ,health ,administration4 7ii7 ,the ,defense ,health ,agency4 7iii7 ,the ,centers for ,medicare ,medicaid ,services4 7iv7 ,the ,food and ,drug ,administration4 7v7 ,the ,centers for ,disease ,control and ,prevention4 7vi7 ,the ,federal ,trade ,commission4 7#b7 ,terms ,each member shall be appointed for a term of #d years1 except that the ,secretary may extend the term of any member for #a additional year if the ,secretary determines such extension appropriate4 7d7 ,operation ,in carrying out the duties under subsection 7b71 the ,commission is not subject to the provisions of chapter #aj of title #e1 ,united ,states ,code4 7e7 ,authorization of appropriations ,there are authorized to be appropriated such sums as may be necessary for each fiscal year to carry out the activities of the ,commission4 #c4 ,publication of fair prices 7a7 ,in general ,not later than the fair price publication date with respect to a fair price applicability year1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall1 with respect to each approved prescription drug1 establish and publish the price that the ,secretary determines to be a fair price for such drug in order for the manufacturer of such drug to provide access to such price-- 7#a7 to any fair price eligible individual who is dispensed such drug during such fair price applicability year 7and to pharmacies1 mail order services1 and other dispensers1 with respect to such individuals who are dispensed such drugs72 and 7#b7 to hospitals1 physicians1 and other providers of services and suppliers that furnish or administer such drug to such an individual during such year4 ,in establishing the fair price for each such drug1 the ,secretary shall take into account the recommendations made by the ,prescription ,drug ,price ,regulatory ,commission 7in this section referred to as the ,commission7 under section #b7;b77#a7 for such drug and such year4 7b7 ,revisions ,the ,secretary may revise the fair price applicable to an approved prescription drug for a fair price applicability year after the fair price publication date with respect to such year has passed if-- 7#a7 the ,secretary has received a recommendation from the ,commission that the fair price be so revised2 7#b7 in the judgment of the ,secretary1 revising such fair price is necessary to account for significant changes to-- 7,a7 supply 7or projected supply7 or demand 7or projected demand7 for such drug2 or 7,b7 any of the other factors described in section #b7;b77#c7 with respect to such drug2 and 7#c7 the ,secretary notifies the manufacturer of such drug not less than #cj days before such revised fair price goes into effect4 7c7 ,temporary fair price waiver 7#a7 ,in general ,the ,secretary may authorize a manufacturer of an approved prescription drug to provide access to such drug to a fair price eligible individual described in paragraph 7#a7 of subsection 7a7 7or to a hospital1 physician1 or other provider of services or supplier described in paragraph 7#b7 of such subsection with respect to such individual7 at a price in excess of a fair price if1 in the judgment of the ,secretary1 such authorization is necessary to maintain access to such drug for all fair price eligible individuals4 7#b7 ,duration of waiver ,an authorization under this subsection shall last for a period of #ij days4 ,the ,secretary may extend such authorization for #a or more additional #ij-;day periods if the ,secretary determines such extension is necessary4 7d7 ,penalties for noncompliance by a manufacturer 7#a7 ,in general ,in addition to any other penalties prescribed by law1 any manufacturer of an approved prescription drug that does not provide access during a fair price applicability year to a price that is equal to or less than the fair price for such drug for such year 7or1 in the case that an authorization under subsection 7c7 is in effect with respect to such manufacturer and drug1 a price that is equal to or less than the price authorized under such subsection7-- 7,a7 to a fair price eligible individual who is dispensed such drug during such fair price applicability year 7and to pharmacies1 mail order services1 and other dispensers1 with respect to such individuals who are dispensed such drugs72 or 7,b7 to a hospital1 physician1 or other provider of services or supplier that furnished or administered such drug to such an individual during such year2 shall be subject to a civil penalty1 for each year and for each drug for which the violation occurs1 equal to #aj times the amount equal to the product of the number of units of such drug so furnished1 dispensed1 or administered during such year and the difference between the price for such drug made available for such year by such manufacturer with respect to such individual or hospital1 physician1 provider of services1 or supplier and the fair price for such drug for such year 7or the price authorized under subsection 7c71 as applicable74 7#b7 ,application ,the provisions of section #aabh;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g7 7other than subsections 7a7 and 7b77 shall apply to a civil monetary penalty under this section in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 #d4 ,fair prices for prescription drugs required 7a7 ,prohibition ,section #cja of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by adding at the end the following3 7jjj7 ,selling1 or offering for sale1 a drug 7or biological product7 at a price that exceeds the fair price published under section #c of the ,regulate the ,price of ,all ,drugs ,act4 4 7b7 ,enforcement by ,federal ,trade ,commission 7#a7 ,unfair or deceptive acts or practices ,a violation of section #cja7;jjj7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or a regulation promulgated under such subsection shall be treated as a violation of a regulation under section #ah7;a77#a77;,b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #eg;a7a77#a77;,b77 regarding unfair or deceptive acts or practices4 7#b7 ,powers of ,commission ,the ,federal ,trade ,commission shall enforce subsection 7jjj7 of such section #cja and any regulation promulgated under such subsection 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 section4 ,any person who violates such subsection or a regulation promulgated under such subsection shall be subject to the penalties and entitled to the privileges and immunities provided in the ,federal ,trade ,commission ,act4 7c7 ,actions by ,states 7#a7 ,in general ,in any case in which the attorney general of a ,state1 or an official or agency of a ,state1 has reason to believe that an interest of the residents of such ,state has been or is threatened or adversely affected by an act or practice in violation of subsection 7jjj7 of such section #cja or a regulation promulgated under such subsection1 the ,state1 as parens patriae1 may bring a civil action on behalf of the residents of the ,state in an appropriate district court of the ,united ,states to-- 7,a7 enjoin such act or practice2 7,b7 enforce compliance with such subsection or such regulation2 7,c7 obtain damages1 restitution1 or other compensation on behalf of residents of the ,state2 or 7,d7 obtain such other legal and equitable relief as the court may consider to be appropriate4 7#b7 ,notice ,before filing an action under this subsection1 the attorney general1 official1 or agency of the ,state involved shall provide to the ,federal ,trade ,commission a written notice of such action and a copy of the complaint for such action4 ,if the attorney general1 official1 or agency determines that it is not feasible to provide the notice described in this paragraph before the filing of the action1 the attorney general1 official1 or agency shall provide written notice of the action and a copy of the complaint to the ,federal ,trade ,commission immediately upon the filing of the action4 7#c7 ,authority of ,federal ,trade ,commission 7,a7 ,in general ,on receiving notice under paragraph 7#b7 of an action under this subsection1 the ,federal ,trade ,commission shall have the right-- 7i7 to intervene in the action2 7ii7 upon so intervening1 to be heard on all matters arising therein2 and 7iii7 to file petitions for appeal4 7,b7 ,limitation on ,state action while ,federal action is pending ,if the ,federal ,trade ,commission or the ,attorney ,general of the ,united ,states has instituted a civil action for violation of subsection 7jjj7 of such section #cja or a regulation promulgated under such subsection 7referred to in this subparagraph as the ,federal action71 no ,state attorney general1 official1 or agency may bring an action under this subsection during the pendency of the ,federal action against any defendant named in the complaint in the ,federal action for any violation of such subsection or regulation alleged in such complaint4 7#d7 ,rule of construction ,for purposes of bringing a civil action under this subsection1 nothing in this ,act shall be construed to prevent an attorney general1 official1 or agency of a ,state from exercising the powers conferred on the attorney general1 official1 or agency by the laws of such ,state to conduct investigations1 administer oaths and affirmations1 or compel the attendance of witnesses or the production of documentary and other evidence4 7d7 ,private right of action 7#a7 ,in general ,a person injured by an act or practice in violation of subsection 7jjj7 of such section #cja or a regulation promulgated under such subsection may bring in an appropriate district court of the ,united ,states-- 7,a7 an action to enjoin the violation2 7,b7 an action to recover three times the amount of damages for actual monetary loss from the violation1 or to receive up to #ej1jjj in damages for each such violation1 whichever is greater2 or 7,c7 both such actions4 7#b7 ,willful or knowing violations ,if the court finds that the defendant acted willfully or knowingly in committing a violation described in paragraph 7#a71 the court may1 in its discretion1 increase the amount of the award to an amount equal to not more than #c times the amount available under paragraph 7#a77;,b74 7#c7 ,costs and attorney's fees ,the court shall award to a prevailing plaintiff in an action under this subsection the costs of such action and reasonable attorney's fees1 as determined by the court4 7#d7 ,limitation ,an action may be commenced under this subsection not later than #e years after the date on which the person first discovered or had a reasonable opportunity to discover the violation4 7#e7 ,nonexclusive remedy ,the remedy provided by this subsection shall be in addition to any other remedies available to the person4 #e4 ,march-in rights for patent ,if the owner of a patent sells a drug in the ,united ,states above the fair price published pursuant to section #c or does not sell an adequate quantity to meet patient demand of a drug in the ,united ,states at the fair price published pursuant to section #c1 the ,secretary of ,health and ,human ,services may assert the right to claim from the owner of any patent for such drug a nonexclusive1 partially exclusive1 or exclusive license in any field of use1 upon terms that are reasonable under the circumstances4 #f4 ,use of the ,defense ,production ,act ,the ,president may use the authorities under title ,i1 title ,,iii1 and title ,,vii of the ,defense ,production ,act of #aiej to increase the domestic supply of a drug if the ,commission has determined that-- 7#a7 there are inadequate facilities or means of production in the ,united ,states to produce an amount of such drug that would satisfy patient demand for such drug2 and 7#b7 foreign supplies of such drug cannot be reliably and sustainability imported into the ,united ,states in such quantities as are necessary for such drug to be purchased at the fair price established for such drug under section #c4 #g4 ,definitions ,in this ,act1 the following definitions apply3 7#a7 ,approved prescription drug ,the term approved prescription drug means-- 7,a7 a drug which may be dispensed only upon prescription and that is described in subparagraph 7,a77i71 7,a77ii71 or 7,a77iii7 of section #aibg7k77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#b772 7,b7 a biological product described in clauses 7i7 through 7iii7 of subparagraph 7,b7 of such section2 7,c7 insulin described in subparagraph 7,c7 of such section and medical supplies associated with the injection of insulin 7as defined in regulations of the ,secretary72 or 7,d7 a vaccine licensed under section #cea of the ,public ,health ,service ,act4 7#b7 ,comparable reference country ,the term comparable reference country means any of the following countries3 7,a7 ,canada4 7,b7 ,france4 7,c7 ,germany4 7,d7 ,italy4 7,e7 ,japan4 7,f7 ,the ,united ,kingdom4 7#c7 ,fair price applicability year ,the term fair price applicability year means a year 7beginning with #bjbg74 7#d7 ,fair price eligible individual ,the term fair price eligible individual means1 with respect to an approved prescription drug1 an individual who is located in the ,united ,states at the time such drug is furnished or administered to such individual4 7#e7 ,fair price publication date ,the term fair price publication date means1 with respect to a fair price applicability year1 ,july #a of the preceding year4 7#f7 ,fair price recommendation date ,the term fair price recommendation date means1 with respect to a fair price applicability year1 ,may #a of the preceding year4