,i #aafth ,,congress #ast ,session ,h4 ,r4 #ddg ,,in ,,the ,,house ,,of ,,representatives ,january #aj1 #bjai,mr4 ,cummings 7for himself1 ,mr4 ,doggett1 ,mr4 ,welch1 ,mr4 ,cohen1 ,mr4 ,khanna1 ,ms4 ,lee of ,california1 ,ms4 ,norton1 ,ms4 ,pingree1 ,ms4 ,de,lauro1 ,mr4 ,sherman1 ,mr4 ,pocan1 ,ms4 ,jayapal1 ,ms4 ,omar1 ,mr4 ,krishnamoorthi1 ,ms4 ,gabbard1 ,mr4 ,langevin1 ,ms4 ,jackson ,lee1 ,mr4 ,blumenauer1 ,ms4 ,schakowsky1 ,mr4 ,neguse1 ,ms4 ,ocasio-,cortez1 and ,ms4 ,tlaib7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to allow for the importation of affordable and safe drugs by wholesale distributors1 pharmacies1 and individuals4 #a4 ,short title ,this ,act may be cited as the ,affordable and ,safe ,prescription ,drug ,importation ,act4 #b4 ,importing affordable and safe drugs 7a7 ,in general ,section #hjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd7 is amended to read as follows3 #hjd4 ,importation of safe and affordable drugs by wholesale distributors1 pharmacies1 and individuals 7a7 ,in general ,not later than #ahj days after the date of enactment of this section1 the ,secretary shall promulgate regulations permitting the importation of qualifying prescription drugs into the ,united ,states1 in accordance with this section4 7b7 ,definitions ,for purposes of this section3 7#a7 ,certified foreign seller ,the term certified foreign seller means a licensed foreign pharmacy or foreign wholesale distributor that the ,secretary certifies under subsection 7d77#a77;,b71 that pays the fee required under subsection 7d77#a77;,c71 and that is included on the list described in subsection 7c74 7#b7 ,foreign wholesale distributor ,the term foreign wholesale distributor means a person 7other than a manufacturer1 a manufacturer's co-licensed partner1 a third-party logistics provider1 or a repackager7 engaged in wholesale distribution4 7#c7 ,importer ,the term importer means a dispenser 7as defined in section #eha7c77 or wholesale distributor registered under section #ejc7;e7 who imports prescription drugs into the ,united ,states in accordance with this section4 7#d7 ,licensed foreign pharmacy ,the term licensed foreign pharmacy means a pharmacy located in ,canada1 or subject to subsection 7e71 another applicable country1 that-- 7,a7 operates in accordance with applicable pharmacy standards set forth by the provincial pharmacy rules and regulations enacted in ,canada1 or1 subject to subsection 7e71 such applicable rules and regulations of the permitted country in which such seller is located2 and 7,b7 is licensed to operate and dispense prescription drugs to individuals in ,canada1 or1 subject to subsection 7e71 the permitted country in which the pharmacy is located4 7#e7 ,qualifying prescription drug ,the term qualifying prescription drug-- 7,a7 means a prescription drug that-- 7i7 is approved for use in patients1 and marketed1 in ,canada1 or subject to subsection 7e71 approved for use in patients1 and marketed1 in another permitted country2 7ii7 is manufactured in a facility registered under subsection 7b77#a7 or 7i7 of section #eaj that is in compliance with good manufacturing practices regulations of the ,food and ,drug ,administration2 7iii7 has the same active ingredient or ingredients1 route of administration1 and strength as a prescription drug approved under chapter ,v1 or1 for purposes of subparagraph 7,b77iv71 is biosimilar to an approved biological product and has the same route of administration and strength as the approved biological product2 and 7iv7 is labeled in accordance with-- 7,i7 the laws of ,canada1 or another country from which importation is permitted pursuant to subsection 7e72 and 7,,ii7 the requirements promulgated by the ,secretary1 which shall include labeling in ,english2 7,b7 with respect to importers only1 includes-- 7i7 peritoneal dialysis solution2 7ii7 insulin2 7iii7 a drug for which a risk evaluation and mitigation strategy is required under section #eje-a2 7iv7 biological products1 as defined in section #cea of the ,public ,health ,service ,act that are proteins 7except any chemically synthesized polypeptides7 or analogous products2 and 7v7 intravenously infused drugs2 and 7,c7 does not include-- 7i7 a controlled substance 7as defined in section #ajb of the ,controlled ,substances ,act72 7ii7 an anesthetic drug inhaled during surgery2 or 7iii7 a compounded drug4 7#f7 ,valid prescription ,the term valid prescription means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by-- 7,a7 a practitioner who has conducted at least #a in-person medical evaluation of the patient2 or 7,b7 a covering practitioner4 7c7 ,publication of certified foreign sellers ,the ,secretary shall publish on a dedicated internet website a list of certified foreign sellers1 including the internet website address1 physical address1 and telephone number of each such certified foreign seller4 7d7 ,additional criteria 7#a7 ,certified foreign sellers 7,a7 ,in general ,to be a certified foreign seller1 such seller shall-- 7i7 be certified by the ,secretary in accordance with subparagraph 7,b72 7ii7 pay the registration fee established under subparagraph 7,c72 and 7iii7 sell only qualifying prescription drugs to importers or individuals who import prescription drugs into the ,united ,states in accordance with this section4 7,b7 ,certification ,to be a certified foreign seller1 the ,secretary shall certify that such seller-- 7i7 is a foreign wholesale distributor or licensed foreign pharmacy operating an establishment1 which may include an online foreign pharmacy1 that is located in ,canada1 or1 subject to subsection 7e71 another permitted country2 7ii7 is engaged in the distribution or dispensing of a prescription drug that is imported or offered for importation into the ,united ,states2 7iii7 has been in existence for a period of at least #e years preceding the date of such certification and has a purpose other than to participate in the program established under this section2 7iv7 in the case of a certified foreign seller that is a licensed foreign pharmacy1 agrees to dispense a qualifying prescription drug to an individual in the ,united ,states only after receiving a valid prescription1 as described in paragraph 7#b77;,c72 7v7 has processes established by the seller1 or participates in another established process1 to certify that the physical premises and data reporting procedures and licenses are in compliance with all applicable laws and regulations of ,canada1 or1 subject to subsection 7e71 the permitted country in which the seller is located1 and has implemented policies designed to monitor ongoing compliance with such laws and regulations2 7vi7 conducts or commits to participate in ongoing and comprehensive quality assurance programs and implements such quality assurance measures1 including blind testing1 to ensure the veracity and reliability of the findings of the quality assurance program2 7vii7 agrees that1 pursuant to subsection 7g71 laboratories approved by the ,secretary may be authorized to conduct product testing to determine the chemical authenticity of sample pharmaceutical products2 7viii7 agrees to notify the ,secretary1 importers1 and individuals of product recalls in ,canada1 or pursuant to subsection 7e71 the permitted country in which the seller is located1 and agrees to cease1 or refrain from1 exporting such product2 7ix7 has established1 or will establish or participate in1 a process for resolving grievances1 as defined by the ,secretary1 and will be held accountable for violations of established guidelines and rules2 7x7 except as otherwise permitted under this section1 does not sell products that the seller could not otherwise legally sell in ,canada1 or1 subject to subsection 7e71 the permitted country in which such seller is located to customers in the ,united ,states2 and 7xi7 meets any other criteria established by the ,secretary4 7,c7 ,certification fee ,not later than #cj days before the start of each fiscal year1 the ,secretary shall establish a fee to be collected from foreign sellers for such fiscal year that are certified under subparagraph 7,b71 in an amount that is sufficient1 and not more than necessary1 to pay the costs of administering the program under this section1 and enforcing this section pursuant to section #cjc7;h71 for that fiscal year4 7,d7 ,recertification ,a certification under subparagraph 7,b7 shall be in effect for a period of #b years1 or until there is a material change in the circumstances under which the foreign seller meets the requirements under such subparagraph1 whichever occurs earlier4 ,a foreign seller may reapply for certification under such subparagraph 7,b71 in accordance with a process established by the ,secretary4 7#b7 ,individuals ,an individual may import a qualifying prescription drug described in subsection 7b7 from ,canada or another country pursuant to subsection 7e7 if such drug-- 7,a7 is dispensed1 including through an online pharmacy1 by a certified foreign seller that is a licensed foreign pharmacy2 7,b7 is purchased for personal use by the individual1 not for resale1 in quantities that do not exceed a #ij-;day supply2 and 7,c7 is filled only after providing to the licensed foreign pharmacy a valid prescription issued by a health care practitioner licensed to practice in a ,state in the ,united ,states4 7e7 ,importation from other countries ,beginning on the date that is #b years after the date on which final regulations are promulgated to carry out this section1 if1 based on a review of the evidence obtained after such effective date1 including the reports submitted under section #b7;d7 of the ,affordable and ,safe ,prescription ,drug ,importation ,act1 that importation of qualifying prescription drugs from ,canada under this section resulted in cost savings for consumers in the ,united ,states and increased access to safe medication1 the ,secretary shall have the authority to permit importation of qualifying prescription drugs by importers and individuals from1 in addition to ,canada1 any country that-- 7#a7 is a member of the ,organisation for ,economic ,co-operation and ,development2 and 7#b7 has statutory or regulatory standards for the approval and sale of prescription drugs that are comparable to the standards in the ,united ,states and that-- 7,a7 authorizes the approval of drugs only if a drug has been determined to be safe and effective by experts employed by or acting on behalf of a governmental entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs2 7,b7 requires that any determination of safety and effectiveness described in subparagraph 7,a7 be made on the basis of adequate and well-controlled investigations1 including clinical investigations1 as appropriate1 conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs2 7,c7 requires the methods used in1 and the facilities and controls used for1 the manufacture1 processing1 and packing of drugs in the country to be adequate to preserve the identity1 quality1 purity1 and strength of the drugs2 and 7,d7 requires the reporting of adverse reactions to drugs and establish procedures to recall1 and withdraw approval of1 drugs found not to be safe or effective4 7f7 ,labeling ,any qualifying prescription drug imported that meets the labeling requirements described in subsection 7b77#e77;,a77iv7 is deemed not misbranded for purposes of section #ejb4 7g7 ,drug testing laboratories ,the ,secretary may approve one or more laboratories to conduct random testing of prescription drugs sold by certified foreign sellers to assess the chemical authenticity of such drugs4 7h7 ,unfair and discriminatory ,acts and practices ,it is unlawful for a manufacturer1 directly or indirectly 7including by being a party to a licensing agreement or other agreement7-- 7#a7 to discriminate by charging a higher price for a prescription drug sold to a certified foreign seller that sells such drug to an importer in accordance with this section than the price that is charged1 inclusive of rebates or other incentives to the country from which the drug is exported1 to another person that is in the same country and that does not import such a drug into the ,united ,states in accordance with this section2 7#b7 except with respect to a prescription drug on the drug shortage list under section #ejf;,e1 discriminate by denying1 restricting1 or delaying supplies of a prescription drug to a certified foreign seller1 on account of such seller's status as a certified foreign seller1 that sells such drug to an importer in accordance with this section1 or by publicly1 privately1 or otherwise refusing to do business with such a certified foreign seller on account of such seller's status as a certified foreign seller2 7#c7 cause there to be a difference 7including a difference in active ingredient1 route of administration1 bioequivalence1 strength1 formulation1 manufacturing establishment1 manufacturing process1 or person that manufactures the drug7 between a prescription drug for distribution in the ,united ,states and the drug for distribution in ,canada or another permitted country1 subject to subsection 7e71 for the purpose of avoiding sales by certified foreign sellers2 or 7#d7 except with respect to a prescription drug on the drug shortage list under section #ejf;,e1 engage in any other action to restrict1 prohibit1 or delay the importation of a prescription drug under this section4 7i7 ,information and records 7#a7 ,biannual reports ,each importer shall submit biannual reports to the ,secretary which shall contain1 for each qualifying prescription drug imported into the ,united ,states-- 7,a7 the unique facility identifier of the manufacturer of the drug1 described in section #eaj2 7,b7 the transaction information described in section #eha7bf7 7other than the information described in subparagraph 7,c772 and 7,c7 the price paid by the importer for the drug4 7#b7 ,maintenance of records by ,secretary ,the ,secretary shall maintain information and documentation submitted under paragraph 7#a7 for such period of time as the ,secretary determines to be appropriate4 7j7 ,suspension of importation 7#a7 ,patterns of noncompliance ,the ,secretary shall require that importation of a specific qualifying prescription drug or importation by a specific certified foreign seller or importer pursuant to this section be immediately suspended if the ,secretary determines that there is a pattern of importation of such specific drug or by such specific seller or importer that involves counterfeit drugs1 drugs that have been recalled or withdrawn1 or drugs in violation of any requirement of this section1 until an investigation is completed and the ,secretary determines that importation of such drug or by such seller or importer does not endanger the public health4 7#b7 ,temporary suspension ,the ,secretary may require that importation of a specific qualifying prescription drug or importation by a specific certified foreign seller or importer pursuant to this section be temporarily suspended if1 with respect to such drug1 seller1 or importer1 there is a violation of any requirement of this section or if the ,secretary determines that importation of such drug or by such seller or importer might endanger the public health4 ,such temporary suspension shall apply until the ,secretary completes an investigation and determines that importation of such drug or by such seller or importer does not endanger the public health4 7k7 ,supply chain security 7#a7 ,purchase from registered facilities and certified foreign sellers 7,a7 ,in general ,except as provided in subparagraph 7,b71 certified foreign sellers who sell qualifying prescription drugs for importation into the ,united ,states pursuant to this section may purchase such drugs only from manufacturers or entities registered under section #eaj or other certified foreign sellers4 7,b7 ,exception ,certified foreign sellers who sell qualifying prescription drugs for importation into the ,united ,states pursuant to this section may purchase such drugs from foreign sellers in ,canada or another permitted country1 even if such foreign seller is not a manufacturer registered under section #eaj or a certified foreign seller1 if the ,secretary enters into a memorandum of understanding or cooperative agreement with ,canada1 or such other permitted country1 to ensure compliance1 to the extent appropriate and feasible1 with subchapter ,h of chapter ,v4 ,the ,secretary shall seek to enter into such a memorandum of understanding or cooperative agreement with ,canada and each country from which importation is permitted under subsection 7e74 7#b7 ,importation tracing ,certified foreign sellers shall provide importers with the unique facility identifier associated with the manufacturer registered under section #eaj of the qualifying prescription drug and the information under paragraph 7#be71 paragraph 7#bf7 7other than subparagraph 7,c771 and subparagraphs 7,d71 7,f71 and 7,g7 of paragraph 7#bg7 of section #eha4 ,certified foreign sellers shall provide such information to individuals purchasing such drugs1 upon request4 7l7 ,r,e,ms ,in the case of an importer that imports a qualifying prescription drug1 where the drug with the same active ingredient or ingredients 7or that is biosimilar to an approved biological product71 route of administration1 and strength that is approved under chapter ,v or section #cea of the ,public ,health ,service ,act is subject to elements to assure safe use under section #eje-a1 such importer shall be subject to such elements to assure safe use1 as applicable and appropriate4 7m7 ,construction ,nothing in this section limits the authority of the ,secretary relating to the importation of prescription drugs1 other than with respect to section #hja7;d77#a7 as provided in this section4 4 7b7 ,penalties with respect to online pharmacies ,section #cjc of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ccc7 is amended by adding at the end the following3 7h7 ,in the case of person operating an internet website1 whether in the ,united ,states or in another country1 that violates section #cja7;aa7 by-- 7#a7 selling1 by means of the internet1 with the intent to defraud or mislead or with reckless disregard for safety of the public1 an adulterated or counterfeit drug to an individual in the ,united ,states2 or 7#b7 dispenses1 by means of the internet1 a drug to an individual in the ,united ,states who the person knows or has reasonable cause to believe1 does not possess a valid prescription for that drug1 such person shall be imprisoned for not more than #aj years or fined not more than #bej1jjj4 4 7c7 ,no preemption ,nothing in this ,act1 including the amendments made by this ,act1 shall be construed to preempt1 alter1 displace1 abridge1 or supplant any remedy available under any ,state or ,federal law1 including common law1 that provides a remedy for civil relief4 7d7 ,reports 7#a7 ,,hhs ,not later than #a year after the date on which final regulations are promulgated to carry out section #hjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd71 as amended by this ,act1 and every #b years thereafter1 the ,secretary of ,health and ,human ,services1 after consultation with appropriate ,federal agencies1 shall submit to ,congress and make public a report on the importation of drugs into the ,united ,states4 7#b7 ,,gao report ,not later than #ah months after the date on which final regulations are promulgated to carry out section #hjd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #chd71 as amended by this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing an analysis of the implementation of the amendments made by this ,act1 including a review of drug safety and cost-savings and expenses1 including cost-savings to consumers in the ,united ,states and trans-shipment and importation tracing processes1 resulting from such implementation4