Sec. 6. Drug manufacturer reporting
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Each manufacturer shall submit to the Secretary, in such format as the Secretary may require, an annual report that includes the following information for each brand name drug of the manufacturer, with respect to the previous calendar year: The average manufacturer price of the drug in the United States and in the reference countries, for the entire year, and broken down for each quarter of the year. The wholesale acquisition cost of the drug in the United States and in the reference countries, for the entire year, and broken down for each quarter of the year.
Cumulative global revenues generated by the drug. Annual net sales revenue generated by the drug in the United States and in the reference countries, for the entire year, and broken down for each quarter of the year. Total expenditures on domestic and foreign drug research and development related to the drug, itemized by— basic and preclinical research; clinical research, reported separately for each clinical trial; 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; and carrying out postmarket requirements related to such drug, including under section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.
Total expenditures on domestic and foreign marketing and advertising related to the drug. Investments in human clinical trials related to the drug, by each trial and each year, including grants, research contracts, tax credits or deductions, and reimbursements from public or private health plans or insurance, and any other public sector subsidies or incentives, such as the fair market value or priority review vouchers or other considerations. The estimated size of the affected patient population.
Additional information the manufacturer chooses to provide related to drug pricing decisions, such as information related to the methodology used to set the price of the drug. Additional information as the Secretary determines necessary to carry out this Act, including information for previous years. Applicable manufacturers shall submit the reports described in subsection
(a)not later than January 15 of the year following the date of enactment of this Act, and of each year thereafter. Any manufacturer that fails to submit information for a drug as required by this section on a timely basis or that knowingly provides false information shall be liable for a civil monetary penalty, as determined by the Secretary under paragraph (2), in addition to any other penalty under other applicable provisions of law. The amount of a civil penalty under paragraph
(1)shall be equal to the product of— an amount, as determined appropriate by the Secretary, which is— not less than 0.5 percent of the gross revenues from sales for the previous calendar year of the drug for which the information was not submitted; and not greater than 1 percent of the gross revenues from sales for the previous calendar year of such drug; and the number of days in the period between— the report due date under subsection (b); and the date on which the Secretary receives the information required to be reported by the manufacturer under this section. The Secretary shall collect the civil penalties under this subsection and shall use such funds to support competitive research grant programs of the National Institutes of Health.