Prohibition against price gouging during a shortage of a covered vaccine

(a)

Prohibition

No person shall introduce or deliver for introduction into interstate commerce any covered vaccine with a price in violation of this section. (b)

Unlawful price

The price of a covered vaccine is in violation of this section if— (1)at the time the vaccine is offered for sale at such price— (A)there is in effect a declaration of a shortage of the vaccine under subsection (c); or (B)the seller knows or has substantial reason to believe there will be a shortage of the vaccine within a period of 60 days, and not later than the end of such period there is in effect a declaration of a shortage of the vaccine under subsection (c); and (2)the price of the vaccine per dose is at least 150 percent of the baseline price of the vaccine per dose (as determined under subsection (d)). (c)

Declaration of vaccine shortage

For any period for which the Secretary of Health and Human Services determines there will be a shortage of a covered vaccine, the Secretary may declare a shortage of that vaccine for purposes of this Act. (d)

Baseline price determination

(1)

In general

Subject to paragraph (2), the baseline price of a covered vaccine per dose is— (A)the average price of the brand of vaccine per dose offered for sale by the seller on the date that is 60 days before the effective date of the applicable declaration under subsection (c); (B)if the seller did not offer for sale the brand of vaccine on the date described in subparagraph (A), the average price of the brand of vaccine per dose offered by the seller during the 12-month period preceding such date; or (C)if the seller did not offer for sale the brand of vaccine on the date described in paragraph (1)(A) or during the period described in paragraph (1)(B), the price determined by the Secretary under paragraph (3). (2)

Exception

If the Secretary finds that the average price of a covered vaccine is substantially different at the time of a declaration of a shortage of that vaccine under subsection (c) than the average price of the vaccine during the 12-month period preceding such declaration because of factors wholly unrelated to the causes of the shortage, the Secretary may determine an appropriate baseline price of the vaccine. (3)

Timing of determinations by Secretary

At the time of declaring a shortage of a covered vaccine under subsection (c), the Secretary shall determine an appropriate baseline price of the vaccine per dose for purposes of paragraph (1)(C) and, if applicable, for purposes of paragraph (2). (e)

Penalties

(1)

In general

Any person who violates subsection (a) shall be imprisoned for not more than 30 days, fined in the amount described in paragraph (2), or both. Each violation of subsection (a) respecting a separate dose of a covered vaccine constitutes a separate offense. (2)

Amount

The amount of a fine under paragraph (1) shall be, for each dose of covered vaccine sold at a price in violation of this section, 3 times the amount of the difference between such price and the applicable baseline price. (f)

Citizen suits

(1)

In general

Except as provided in paragraph (2), any person may commence a civil action on his own behalf to compel compliance with subsection (a) against any person (including the United States and any other governmental instrumentality or agency to the extent permitted by the Eleventh Amendment to the Constitution) for any alleged violation of subsection (a). The United States district courts shall have jurisdiction, without regard to the amount in controversy or the citizenship of the parties, to compel compliance with such subsection. (2)

Notice required

No action may be commenced under this subsection— (A)prior to 30 days after the plaintiff has given notice of the alleged violation (in such manner as the Secretary may require) to the Secretary and to each alleged violator of subsection (a); or (B)if the Secretary or the Attorney General of the United States has commenced and is diligently prosecuting a criminal or civil action in a court of the United States to require each such alleged violator to comply with subsection (a), but in any such civil action in a court of the United States any person may intervene as a matter of right. (3)

Intervention

In any action under this subsection, the Secretary or the Attorney General of the United States, if not a party, may intervene as a matter of right. (4)

Award of costs

The court, in issuing any final order in any action brought under this subsection, may award costs of litigation (including reasonable attorney and expert witness fees) to any party whenever the court determines such an award is appropriate. (g)

Action for damages

If a person purchases a covered vaccine at a price in violation of this section, the person may bring a civil action against the seller of the vaccine in a district court of the United States to recover— (1)the amount that is 3 times the amount of the difference between such price and the applicable baseline price; and (2)the costs of the action (including reasonable attorney and expert witness fees). (h)

No preemption

Nothing in this Act shall be construed as— (1)affecting the authority of a State to regulate the distribution and sale of vaccines; or (2)restricting the right of any person (or class of persons) under any statute or common law to seek enforcement of a requirement relating to the distribution or sale of a vaccine or to seek any other relief. (i)

Definitions

For purposes of this Act: (1)The term covered vaccine means a vaccine intended to prevent or mitigate the effects of influenza or any biological terrorist agent. (2)The term Secretary means the Secretary of Health and Human Services.