KEI has joined unions, NGOs and payors on a letter sent to Senator Grassley and Sen. Feinstein, the chair and ranking member of the Judiciary Committee, thanking them for their support of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974), and urging members of the committee to vote in favor of the bill.
The CREATES Act has garnered bipartisan support for addressing systemic abuses of regulatory rules by manufacturers to deny would-be generic or biosimilar companies access to necessary quantities of products subject to a risk evaluation and mitigation strategy (REMS). These abuses result in costly delays in getting affordable generics and biosimilars to market. The Congressional Budget Office has estimated that the CREATES Act would save $3.8 billion over ten years.
The CREATES Act would grant the right to bring a civil action in any case where a manufacturer fails to provide sufficient quantities of the covered product:
(b) Civil Action For Failure To Provide Sufficient Quantities Of A Covered Product.—
(1) IN GENERAL.—An eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable, market-based terms.
The law establishes that the remedies for violation include attorneys fees and costs, as well as a compulsory license of sufficient quantities of the covered product on commercially reasonable terms:
(4) REMEDIES.—
(A) IN GENERAL.—If an eligible product developer prevails in a civil action brought under paragraph (1), the court shall—
(i) order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable, market-based terms;
(ii) award to the eligible product developer reasonable attorney fees and costs of the civil action; and
(iii) award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide other eligible product developers with sufficient quantities of a covered product on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence—
(I) that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification; or
(II) that the license holder failed to comply with an order issued under clause (i).
The full list of signees includes:
AARP
AFL-CIO
Alliance for Retired Americans
Alliance of Community Health Plans
America’s Health Insurance Plans
America’s Physician Groups
American College of Physicians
American Consumer Institute
American Hospital Association
American Gastroenterological Association
American Society of Health System Pharmacists
Anthem
Ascension
Association for Accessible Medicines
Blue Cross Blue Shield Association
Blue Cross Blue Shield of Arizona
Blue Cross Blue Shield of Michigan
Blue Shield of California
Campaign for Sustainable Rx Pricing
Cancer Prevention and Treatment Fund
Chronic Illness Advocacy & Awareness Group
Coalition to Reduce Federal Spending
Colorado Consumer Health Initiative
Consumers Union
CVS Health
Doctors for America
Express Scripts
Families USA
Federation of American Hospitals
FreedomWorks
Greater New York Hospital Association
Healthcare Supply Chain Association
Kaiser Permanente
Knowledge Ecology International
National Coalition on Health Care
National Committee to Preserve Social Security and Medicare
National Physicians Alliance
Patients for Affordable Drugs
People of Faith for Access to Medicines
Pharmaceutical Care Management Association
Premier healthcare alliance
Prime Therapeutics
Public Citizen
Social Security Works
Universal Health Care Foundation of Connecticut
Vizient
The letter is available here.