Patient Advocates Press Congress to Preserve the Integrity of the Nation’s Drug Safety System
In a joint letter addressed to the
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Speaking for the millions of Americans with serious diseases like cancer, kidney disease, and multiple sclerosis who currently benefit from medicines marketed with REMS safety measures, the joint letter stressed the need for stringent REMS safety precautions called "Elements to Assure Safe Use" (ETASU) and especially restricted distribution programs that prevent harmful exposure to medicines when there is no room for error. Currently, there are about 40 REMS with
Because REMS safeguards prevent drug diversion and make it possible for
Of key concern to the drug safety advocates are provisions that would:
- Eliminate established procedures whereby
FDA ensures 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 a generic 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 behind closed doors without stakeholder input
- 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, 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
The joint letter, sent on (date) to the leaders of the
About the
Formed in 2015 and spearheaded by the
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