Patient safety is a top priority of GPhA and its Biosimilars Council. Our members strongly support FDA-mandated Risk Evaluation and Mitigation Strategies (REMS), patient safety programs that serve a clear public health purpose – ensuring that the benefits of a drug outweigh its safety risks.
Congress, the 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 in order to preserve their market share for as long as possible.
- 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.
- 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.
- 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.
- These abuses are growing and these avoidable hurdles to pharmaceutical competition come at great cost. Misuse of REMS costs patients, payors, government programs and the entire health care system more than $5 billion dollars annually.
GPhA and the Biosimilars Council are working to strengthen REMS programs and stop these anticompetitive business practices that drive up costs and impede patient access to affordable medicines.