Pull Shared System REMS Guidance: NACDS
The National Association of Chain Drug Stores says it is concerned that FDA draft guidances on waivers of the single, shared system (SSS) risk evaluation and mitigation strategy (REMS) requirement and on development of a shared system risk evaluation and mitigation strategy would not stop brand drug manufacturers from manipulating the system to prevent competition from generic or biosimilar products. In its comment letter, NACDS says it strongly discourages FDA from waiving single, shared system REMS requirements, as it could create significant burdens for healthcare providers that may discourage the prescribing and dispensing of generics.
“Given the significant burden that multiple REMS for the same drugs would have on healthcare providers, and subsequent burdens on the patient community, waiving the single, shared system requirements would likely not meet the standard wherein ‘the burden of creating a single, shared system outweighs the benefit of a single system,’” the letter says. “In light of the various concerns discussed above, we urge FDA to revoke the draft guidance addressing waivers of the single, shared system REMS and refrain from issuing waivers to single, shared system REMS requirements. Instead, we ask FDA to revise the draft guidance on development of a shared system REMS to further identify and address the systemic loopholes that are being exploited to prevent new generic products from using single, shared system REMS.”
The American Pharmacists Association (APhA) says a single, shared system REMS makes it easier for pharmacists and other healthcare providers to complete administrative requirements and distribute REMS materials and information to patients. “However,” it says, “APhA is aware that an SSS REMS can be used as a mechanism to delay marketing of generic drugs. APhA is sensitive to the important balance FDA must strike when evaluating the benefits and burdens of SSS REMS, especially considering the need to increase competition in the U.S. pharmaceutical industry to help drive down drug prices.” The association offers recommendations on the impact on healthcare providers and patients, benefits of having an SSS REMS, burden of forming an SSS, and comparability of separate REMS.
The Association for Accessible Medicines (AAM) says it supports issuance of the draft waiver guidance and commends agency efforts to provide additional guidance on single, shared risk REMS requirements. And it says it applauds FDA’s broader efforts to address brand drug companies taking advantage of REMS requirements as a means to protect brand monopolies.
“FDA’s guidances are helpful,” AAM cautions, “because they send a message that FDA believes gaming of the SSS REMS negotiations is a harmful tactic that delays generic and biosimilar competition, depriving patients of access to these important medicines. The guidances also convey that FDA will be doing all it can, within its current authorities, to grant waivers in cases in which brands are needlessly prolonging negotiations toward a single, shared system. The guidances, however, closely track existing FDA practices and do not impose new expectations or obligations on brand companies to negotiate in a timely manner and in good faith.”
Finally, the Biotechnology Innovation Organization says it believes it is important that FDA, in framing the requirements for waivers, remain mindful of the principal purpose behind the statutory framework governing REMS — protecting patients and public health. “In any final guidance,” it says, “we ask that FDA reaffirm the safety benefits associated with SSS REMS and clarify the agency’s safety expectations for separate, waiver-granted systems will be comparable with any corresponding innovator REMS.”