Drugs

Shared System REMS Comments

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA efforts in a guidance to clarify when and how the agency will consider waiving the requirement that an ANDA applicant use a single shared system (SSS) of elements to assure safe use with its reference-listed drug. “PhRMA supports FDA’s proposed case-specific analysis of SSS waiver requests and believes that patient safety should be the paramount consideration when FDA assesses whether a waiver of the SSS requirement is warranted,” the association’s comment letter says. The letter also recommends revisions to the guidance in several respects.

The Pharmaceutical Care Management Association (PCMA) says that while there are obvious efficiency benefits to using a shared REMS system for both manufacturers and healthcare providers, the road to getting to a shared system may involve long and complex negotiations between or among drug manufacturers that may or may not be successful, especially when aspects of the REMS may be covered by a patent or trade secret. “Indeed,” PCMA says, “brand manufacturing companies may have a clear incentive not to cooperate with manufacturers holding an ANDA, in an attempt to forestall generic competition for their drug. Such noncooperation is anticompetitive and keeps prices unnecessarily high.”

PCMA says it strongly supports the FDA proposal to allow an ANDA applicant to request a waiver from the use of a shared REMS, or for FDA to issue a waiver on its own initiative. The association also supports that if a separate REMS is to be developed, FDA will on a case-by-case basis evaluate the components of the separate REMS and the applicant’s proposed elements to assure safe use to determine whether they are comparable to the innovator’s. “We believe such actions will mitigate noncompetitive behavior exhibited by some brand manufacturers to keep generics off the market yet still provide patients the protections they need and deserve,” it says.

Perrigo lists specific changes it wants to see in the guidance.

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