Sec. 101. Drug manufacturer reporting
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Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq.) is amended by adding at the end the following: In this section: The term independent charity patient assistance program means any organization described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from taxation under section 501(a) of such Code and which is not a private foundation (as defined in section 509(a) of such Code) that offers patient assistance. The term manufacturer patient assistance program means an organization, including a private foundation (as so defined), that is sponsored by, or receives funding from, a manufacturer and that offers patient assistance.
Such term does not include an independent charity patient assistance program. The term patient assistance means assistance provided to offset the cost of drugs for individuals. Such term includes free products, coupons, rebates, copay or discount cards, and other means of providing assistance to individuals related to drug costs, as determined by the Secretary. An applicable manufacturer of an approved drug (including a drug approved under subsection
(c)or
(j)of section 505 of the Federal Food, Drug, and Cosmetic Act and a biological product licensed under subsection
(a)or
(k)of section 351 of this Act) shall submit to the Secretary and to Congress an annual report, in such format as the Secretary shall require, outlining with respect to the previous calendar year (except as provided in subsection (c)(3))— with respect to each such drug— the total expenditures of the manufacturer on— domestic and foreign drug research and development, including an itemized description of— basic and preclinical research; clinical research, broken out by clinical trial phase; development of alternative dosage forms and strengths for the drug molecule or combinations, including the molecule; other drug development activities, such as nonclinical laboratory studies and record and report maintenance; pursuing new or expanded indications for such drug through supplemental applications under section 505 of the Federal Food, Drug, and Cosmetic Act; carrying out postmarket requirements related to such drug, including under section 505(o)(3) of such Act; carrying out risk evaluation and mitigation strategies in accordance with section 505–1 of such Act; and marketing research; cost of goods sold, broken out by source and cost of each component and identifying specific costs that reflect internal transfers within the manufacturer's company; acquisition costs in total and per unit sold, including costs for the purchase of patents and licensing; and marketing and advertising for the promotion of the drug, including a breakdown of amounts aimed at consumers, prescribers, managed care organizations, and others; the gross revenue, net revenue, gross profit, and net profit to the manufacturer; the total number of units of the prescription drug that were sold in interstate commerce in the most recently completed calendar year; pricing information, including— wholesale acquisition cost; net average price realized by prescription drug benefit managers for drugs provided to individuals in the United States, after accounting for any rebates or other payments from the manufacturer to the pharmacy benefit manager and from the pharmacy benefit manager to the manufacturer; and the net price of the drug, after accounting for discounts, rebates, or other financial considerations, charged to purchasers in each applicable country of the Organisation for Economic Co-operation and Development; information, including the dollar value to the recipient of manufacturer patient assistance programs offered by the manufacturer or a manufacturer patient assistance program sponsored by or associated with the manufacturer, per patient, including— the specific forms of such patient assistance available, such as coupons, rebates, discount codes, or copayment cards; the total dollar value of each manufacturer patient assistance program and the dollar value of each program to the patient, including the basis used to assign value to the manufacturer patient assistance program; the duration of each type of such patient assistance available; and any requirements, such as income thresholds, for how to qualify for such patient assistance; and information on usage of patient assistance offered by the manufacturer or a manufacturer patient assistance program sponsored by or associated with the manufacturer, including— the number of transactions of each type of patient assistance used; the number of individuals receiving each type of patient assistance; the total value of each type of patient assistance that was used; the average length of time that each individual received each type of patient assistance; the number of individuals who were discontinued from receiving each type of patient assistance; and complete documentation of the terms and conditions for an individual agreeing to participate in the program for each type of patient assistance provided; any Federal benefits received by the manufacturer, including the amounts and periods of impact for each such benefit, including tax credits, patent applications that benefitted from a grant from the National Institutes of Health, patent extensions, exclusivity periods, and other Federal benefits with respect to such drug; and the percentage of research and development expenditures on— activities conducted by the manufacturer; activities funded by Federal entities; and activities conducted by other entities such as academic institutions or other drug manufacturers; executive compensation for the chief executive officer, chief financial officer, and the 3 other most highly compensated executive officers, including bonuses, paid by such manufacturer, and stock options affiliated with the manufacturer that were offered to or accrued by such officers; any additional information the manufacturer chooses to provide related to drug pricing decisions, such as total expenditures on drug research, drug development, and clinical trials on drugs that failed to receive approval by the Food and Drug Administration, a list of drugs and drug prices against which the manufacturer compared the applicable drug, and other relevant information; and any other information as the Secretary may require. Drug manufacturers shall submit the annual reports required under this section submitted to the Secretary in a usable format, as the Secretary may require. The Secretary shall collate the reports received as described in subparagraph
(A)and submit such collated reports to Congress, together with an analysis of the reports by the Secretary that includes— a summary of data from the reports; consideration of factors such as trends on research and development costs, Federal benefits, and manufacturer patient assistance programs; and the relationship between the factors described in clause
(ii)and prescription drug prices. The Secretary shall make the reports submitted by manufacturers as described in subparagraph
(A)and the collated reports together with the analysis of the Secretary described in subparagraph
(B)publicly available, including by posting such reports to the Internet website of the Department of Health and Human Services, in a searchable format. A drug manufacturer shall submit all information required under subsection
(b)with respect to each applicable drug, in a single, annual report. An applicable drug manufacturer shall submit a report pursuant to this section one year after the date of enactment of the Improving Access To Affordable Prescription Drugs Act (except as provided in subparagraph (B)) that includes the information required under subsection (b)(1) with respect to each calendar year since the drug for which the report is required was approved under section 505 of the Federal Food, Drug, and Cosmetic Act, licensed under section 351 of this Act, or received an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act or section 351(a)(3) of this Act, or the calendar year in which the manufacturer acquired the drug. In the case of an applicable drug manufacturer that has fewer than 500 employees, the initial report described in subparagraph
(A)shall be submitted by a date determined by the Secretary, which shall be not earlier than the date described in subparagraph
(A)and not later than the date that is 3 years after the date of enactment of the Improving Access To Affordable Prescription Drugs Act . The Secretary shall report to the Office of the Inspector General any manufacturer's failure to submit a complete report as required under this section. Any manufacturer that fails to submit a complete report required under this section shall be subject to a civil penalty of up to $200,000 for each day on which the violation continues. The Secretary shall collect the civil penalties under this subsection, and without further appropriation, shall use such funds to support the programs under sections 409K and 485E, and, at the discretion of the Secretary, research of the National Institutes of Health and other activities authorized under the Improving Access To Affordable Prescription Drugs Act , including any amendments made by such Act. .
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Sec. 101
Drug manufacturer reporting
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