REMS/Sample Acquisition Remedies

ENSURING BENEFITS OUTWEIGH RISKS

Patient safety is a top priority of the AAM and its Biosimilars Council. For this reason, our members strongly support current FDA-mandated Risk Evaluation and Mitigation Strategies (REMS). These patient safety programs are designed to serve a clear public health purpose – that of ensuring that the benefits of a drug outweigh its safety risks.

Congress, FDA and others have repeatedly raised concerns that these programs are not being used as intended. Certain brand drug companies continue to exploit regulatory loopholes in REMS programs, blocking patient access and delaying market entry of generics and biosimilars to preserve their market share for as long as possible.

Stop REMS Abuse

Key Points

• REMS components can include specific safety instructions for healthcare professionals and distributors prior to prescribing, shipping, or dispensing a drug.
• Certain brand drug companies have been denying manufacturers of generic drugs or biosimilars access to the product samples they need to conduct bioequivalence studies necessary to gain FDA approval and pursue market entry. Even in cases where FDA certifies that a generic company can safely handle a drug for clinical use, brand companies are refusing to sell them their drug.
• Some brand drug companies are using tactics that grew out of REMS Elements to Assure Safe Use (ETASU) requirements to delay generic competition for REMS and non-REMS products.
• 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.
• Misuse of REMS costs patients, payors, government programs and the entire health care system more than $6 billion dollars annually.

AAM Efforts:

AAM and the Biosimilars Council are working to strengthen REMS programs to ensure that 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.