Frank Pallone

“ MANUFACTURER.—The term ‘manufacturer’ means the person— “ (A) that holds the application for a drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of the Public Health Service Act; or “ (B) who is responsible for setting the wholesale acquisition cost for the drug. ”

“ False Information.—Any manufacturer that submits a report for a drug as required by this section that knowingly provides false information in such report is subject to a civil monetary penalty in an amount not to exceed $100,000 for each item of false information. “ (g) Public Posting.— “ (1) IN GENERAL.—Subject to paragraph (4) , the Secretary shall post each report submitted under subsection (b) on the public website of the Department of Health and Human Services the day the price increase of a qualifying drug is scheduled to go into effect. ”

“ FORMAT.—In developing the format in which reports will be publicly posted under paragraph (1) , the Secretary shall consult with stakeholders, including beneficiary groups, and shall seek feedback from consumer advocates and readability experts on the format and presentation of the content of such reports to ensure that such reports are— “ (A) user-friendly to the public; and “ (B) written in plain language that consumers can readily understand. ”