Drugs

Groups Fear Weakened REMS

David McFarland

— 2 min read
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Members of 16 public health, patient advocacy, health professional, and disease organizations are voicing concerns about proposed legislation that they say will weaken drug safety protections and make it easier for potentially dangerous drugs to get into the wrong hands. Members of the Patients’ Alliance for Drug Safety Protections say that the recently-introduced Creating and Restoring Equal Access to Equivalent Samples Act of 2016 (S. 3056), sponsored by Sen. Patrick Leahy (D-VT) would significantly curtail FDA authority to regulate high-risk drugs, including medicines that can cause severe birth defects, organ damage, and death when not carefully controlled.

While supporting the bill’s goal to speed development of less expensive generic drugs, the alliance members say that as it is written, it will force the sale of medicines carrying serious risks to generic drug marketers for comparison testing while eliminating established procedures that ensure that generic drug manufacturers adopt the same safety protocols when testing the drugs in human subjects, as well as permitting separate generic REMS (Risk Evaluation and Mitigation Strategy) of unproven safety without stakeholder input.

The alliance statement cites provisions in the legislation that they say would: 

  •          eliminate established procedures through which FDA ensures that both innovator and generic manufacturers are held to the same safety requirements when testing potentially dangerous drugs;
  •          limit FDA’s authorization process for how generic companies obtain samples for clinical testing;
  •          curtail the methods the agency now uses to verify that a generic drug developer has the safety track record and capability to follow a rigorous risk management system;
  •          not require evidence demonstrating that separate REMS will ensure the same level of safety, and permit unproven generic REMS approvals without stakeholder input; and
  •          allow generic manufacturers to attest to the rigor of their risk management program instead of requiring the companies to submit detailed documentation that is reviewed and approved by FDA.

“Although the goal of speeding the development of less expensive generic medicines and biosimilars is laudable,” the group says in its letter to the Senate Judiciary Committee, “we urge legislators to act with an abundance of caution when considering proposals such as the CREATES Act. If the current system is changed, then it must include a robust FDA process that goes beyond reviewing (a) self-attestations form and includes a review of a product developer’s actual capabilities and its safety history.”

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