Knowledge Ecology International and 43 other health-care interested groups are calling on Congress to pass the CREATES Act.
The CREATES Act, or the “Creating and Restoring Equal Access To Equivalent Samples Act of 2017”, is a bipartisan proposal to speed the entry of generic and biosimilar medicines, increasing competition and helping to lower prices.
In order to register a generic or biosimilar drug, the generic manufacturer must be able to obtain a sample of the originator product for testing, as it is required to show that it is bioequivalent to the branded drug in the case of a prospective generic drug, and interchangeable in the case of a prospective biosimilar. In some instances, the companies which hold the license to the originator products prevent generic manufacturers from accessing these samples, engaging in a practice commonly referred to as “REMS abuses”.
For many drugs, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS) from its manufacturer, in order to prove that the benefits of a medicine outweigh its potential safety risk. In some cases, REMS programs restrict access to a certain drug to only some entities, as part of a strategy to minimize safety risks. In practice, some manufacturers have abused the REMS process as a way to limit distribution networks and restrict access to the samples which generic manufacturers need in order to register their products. The CREATES Act allows generic product developers to bring civil action against a license holder who restricts access to sufficient quantities of a product on commercially reasonable terms.
As there are versions of the CREATES Act in both the House of Representatives and Senate, the coalition’s letter is addressed to Republican and Democratic leaders in both chambers. KEI joins the following groups in signing onto this letter:
AARP
Academy of Managed Care Pharmacy
Alliance of Community Health Plans
America’s Health Insurance Plans
American College of Physicians
American Consumer Institute
American Hospital Association
American Society of Health-System Pharmacists
Anthem
Ascension
Association for Accessible Medicines
Autistic Self Advocacy Network
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
Coalition to Reduce Federal Spending
Colorado Consumer Health Initiative
CVS Health
Consumers Union
Doctors for America
Express Scripts
Families USA
Federation of American Hospitals
FreedomWorks
Greater New York Hospital Association
Healthcare Supply Chain Association
I-MAK (Initiative for Medicines, Access & Knowledge)
Kaiser Permanente
Knowledge Ecology International
National Coalition on Health Care
National Committee to Preserve Social Security and Medicare
Patients For Affordable Drugs
Pharmaceutical Care Management Association
People’s Action Institute
People of Faith for Access to Medicines
Premier Healthcare Alliance
Prime Therapeutics
Public Citizen
Social Security Works
Union for Affordable Cancer Treatment
Universal Health Care Foundation of Connecticut
Vizient