Sec. 3. Ending government-granted monopolies for excessively priced drugs
284 words·~1 min read·
/bill/116/s/102/is/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
With respect to any brand name drug, if the Secretary determines under section 2 that the price of the drug is excessive, the Secretary— shall waive or void any government-granted exclusivities with respect to such drug, effective on the date that the excessive price determination under section 2 is made for such drug; and shall grant open, non-exclusive licenses allowing any person to make, use, offer to sell or sell, or import into the United States such drug, and to rely upon the regulatory test data of such drug, in accordance with section 4.
The Secretary shall prioritize the review of, and act within 8 months of the date of the submission of a generic drug application or a biosimilar biological product application if such application references a drug licensed under subsection (a)(2). If the Secretary determines that the manufacturer of an excessively priced drug (as determined under section 2(a)) has increased the price of such drug during the period beginning on the date on which such price determination is made and ending on the date on which an entity begins manufacturing the drug under an open, non-exclusive license under subsection (a)(2), the Secretary may file a civil action in the United States district court for the district in which the manufacturer is located, or in the United States district court for the District of Columbia, to recover damages in an amount equal to not less than the total amount of revenue derived by the manufacturer as a result of any such price increase during such period.
In actions brought under this subsection, the district courts shall have jurisdiction to grant all appropriate relief including, but not limited to, injunctive relief and compensatory damages.