S. 366Senate116th Congress (2019-2021)In Committee

FLAT Prices Act

Introduced February 6, 2019

AI-Generated Summary

Updated April 14, 2026 at 1:25 AM UTC

The FLAT Prices Act shortens the monopoly period (market exclusivity) granted to prescription drugs when manufacturers sharply raise prices. It targets drugs whose wholesale acquisition cost jumps beyond set percentages over one‑, two‑, or three‑year periods, reducing their exclusivity time as a penalty. The bill also requires prompt reporting of such price hikes and allows the Health and Human Services Secretary to grant waivers when the increase is necessary for production and does not unduly limit access.

Key Provisions

  • If a drug maker raises a prescription drug’s wholesale acquisition cost by more than 10% in one year, 18% in two years, or 25% in three years, the drug’s remaining market‑exclusivity period is cut by 180 days.
  • For each additional 5% increase above those thresholds, the exclusivity is reduced by another 30 days.
  • Manufacturers must notify the HHS Secretary within 30 days of hitting a price‑increase threshold; failing to do so adds a 30‑day reduction for each day the report is late.
  • The Secretary can waive or lessen the exclusivity reduction if the company shows the price hike is needed for production and does not harm patient access or public health.

Legislative Activity

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1 earlier action
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S921-922)

February 6, 2019

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SenateIntro Referral

Introduced in Senate

February 6, 2019

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S921-922)

February 6, 2019

Floor Debate

3 members

What members said about S. 366 on the floor

1 Republican2 Democrats
Benjamin L. Cardin
Sen. Benjamin L. CardinD-MD · Feb 6, 2019

Mr. President, I rise today with my colleague Senator Wicker to bring your attention to our proposed Dental Loan Repayment Assistance Act. This legislation will provide incentives for dental and…

Susan M. Collins
Sen. Susan M. CollinsR-ME · Feb 6, 2019

Mr. President, I rise today to discuss the Reviving America's Scenic Byways Act, a bill I have introduced with my colleague from Maryland, Senator Cardin. Our bill seeks to revive the long- dormant…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Feb 6, 2019

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Feb 6, 2019

Mr. President, I ask unanimous consent that the text of the bill be printed in the Record.

Bill Text

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Introduced in SenateIssued February 6, 2019

II

116th CONGRESS

1st Session

S. 366

IN THE SENATE OF THE UNITED STATES

February 6, 2019

Mr. Durbin (for himself, Ms. Harris, Ms. Smith, Ms. Klobuchar, and Mr. Blumenthal) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

A BILL

To shorten monopoly periods for prescription drugs that are the subjects of sudden price hikes.

1.

Short title

This Act may be cited as the Forcing Limits on Abusive and Tumultuous Prices or the FLAT Prices Act.

2.

Reduced market exclusivity

(a)

Penalty

If the manufacturer of a prescription drug approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) increases the price of such drug as described in subsection (b), any remaining period of market exclusivity with respect to such drug shall be reduced as follows:

(1)

With respect to any price increase described in subsection (b), such market exclusivity shall be reduced by 180 days.

(2)

For every 5 percent price increase over the 10 percent, 18 percent, or 25 percent, respectively, threshold price increases described in subsection (b), such market exclusivity shall be reduced for an additional 30 days.

(b)

Price increase

A price increase described in this subsection is an increase in the wholesale acquisition cost (as defined in section 1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w–3a(c)(6)(B))) of a prescription drug of more than 10 percent over a 1-year period, more than 18 percent over a 2-year period, or more than 25 percent over a 3-year period.

(c)

Report on price increase

(1)

In general

A drug manufacturer that increases the price of a prescription drug as described in subsection (b) shall report such increase to the Secretary of Health and Human Services (referred to in this section as the Secretary) within 30 days of meeting the criteria for a price increase under such subsection.

(2)

Failure to submit report

In the case of a drug manufacturer that does not submit a report required under paragraph (1) within the 30-day period described in such paragraph, in addition to the penalty under subsection (a), the period of market exclusivity with respect to such drug shall be reduced by 30 days for each day after the due date of the report until the report is submitted.

(d)

Waiver

The Secretary may waive, or decrease, the reduction in the period of market exclusivity that would otherwise apply under subsection (a) with respect to a prescription drug if—

(1)

the manufacturer of such drug submits—

(A)

a report under subsection (c)(1); and

(B)

an application for such a waiver, at such time, in such manner, and containing such information as the Secretary may require; and

(2)

based upon the information in such application, the Secretary determines that—

(A)

the price increase is necessary to enable production of the drug, does not unduly restrict patient access to the drug , and does not negatively impact public health; and

(B)

such waiver or decrease constitutes a deviation from the reduction in market exclusivity that would otherwise apply under subsection (a) only to the extent necessary to achieve drug production objectives.

(e)

Period of market exclusivity

For purposes of this section, the term period of market exclusivity means any period of market exclusivity granted with respect to a prescription drug under clause (ii), (iii), or (iv) of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E)), section 505(j)(5)(B)(iv) of such Act, clause (ii), (iii), or (iv) of section 505(j)(5)(F) of such Act, or paragraphs (6) or (7) of section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)).