FDA-mandated Risk Evaluation and Mitigation Strategies (REMS) serve the clear public health purpose of ensuring the benefits of a drug outweigh its safety risks. AAM and the Biosimilars Council are working to ensure that REMS programs are properly used to protect patients and cannot be used to promote anticompetitive business practices.
And yet these programs are not always being treated as intended. To preserve their market share for as long as possible, certain brand drug companies have been denying manufacturers of generic drugs or biosimilars access to the product samples of the brand-name medicine that generic and biosimilar manufacturers require to conduct the bioequivalence studies necessary to gain FDA approval and pursue market entry.
Bipartisan legislation in the House and Senate – The CREATES Act (S. 340/H.R. 965) and the FAST Generics Act (H.R. 985) – prohibits companies from using restricted access programs to avoid generic competition.
Congress, FDA and the Federal Trade Commission have repeatedly decried REMS abuse. Misuse of REMS costs patients, payers, government programs and the entire health care system more than $5 billion dollars annually.
As these bad actors continue to exploit regulatory loopholes in REMS programs, they block patient access and delay market entry of generics and biosimilars. Even when FDA certifies a generic company can safely handle a drug for clinical use, brand companies are refusing to sell them their drug. To delay generic competition for REMS and non-REMS products, some brand drug companies are using tactics that grew out of REMS Elements to Assure Safe Use (ETASU) requirements.
The abuses are growing. FDA requires REMS programs for up to 40 percent of new drug approvals. And as the biosimilar market begins to develop, the inability of biosimilar manufacturers to obtain samples of brand biologics for early development testing purposes will also delay access.
AAM and the Biosimilars Council are working to strengthen REMS programs to ensure they are properly used to protect patients and cannot be used to promote anti-competitive business practices that drive up costs and impede patient access to affordable medicines.
- Increase Competition & Access — Support CREATES Act
- REMS Abuse Impeding Patient Access to Generic Drugs – Myths and Facts
- Expediting Approval of Generic Applications and Stopping REMS Abuse Among Top Priorities for Nation’s Leading Patient Advocacy Group
- Biosimilars: Breaking Down Barriers to Patient Access (REMS)
- Generic Prescription Drugs: Your Health. Our Commitment.