US FDA Issues Draft Guidance On REMS For Multiple Prescription Drugs Including Biologicals

Bengaluru, 31 Aug 2018: The US FDA has issued a draft guidance on the development of a shared system for risk valuation and mitigation strategy (REMS).

This guidance provides recommendations to industry on the development of a shared system REMS for multiple prescription drugs including biologicals. But the guidance does not discuss the process for requesting a waiver of the single, shared system REMS requirement that applies to abbreviated new drug applications (ANDAs) referencing a listed drug with an approved REMS.

According to Prema Desai, pharma consultant, REMS means managing a known or potential serious risk associated with a drug or biological product. Components of REMS are medication guide, communication plan, implementation plan and elements to assure safe use (ETASU)

The regulator would require a REMS before initial approval of a new drug application (NDA) to ensure that the benefits of the product,  outweigh its risks, after the drug has been approved.

A shared system REMS encompasses multiple prescription drug products and is developed and implemented jointly by two or more applicants. A REMS that includes more than one product but only a single applicant is not considered a shared system REMS. A shared system REMS can be a programme shared by a drug that is the subject of an ANDA.

A shared system REMS uses a single document, agreed to by all applicants and approved as part of each application. The applicants generally share in the implementation and maintenance of any database and infrastructure used for the programme, and are jointly responsible for carrying out all or assessments. There may be product-specific materials like medication guide that will not be shared across applicants.

Further a shared system for REMS with elements to assure safe use (ETASU) may offer benefits to drug applicants and stakeholders in the health care delivery system. The benefits may vary, but generally stem from opportunities for increased efficiencies for stakeholders and applicants.

Use of a shared system REMS may benefit the applicants by providing opportunities for sharing the cost of developing and implementing the programme. These cover the analysis of adverse events or other safety data, and periodic assessments to determine whether the REMS is meeting its intended risk management objective. 

In addition, a shared system REMS generally uses a shared infrastructure for all of the products. This generally provides a single portal for REMS participants to engage in and undertake the activities of the programme. For example, prescribers and pharmacists can complete certification and other administrative requirements once for multiple drugs, rather than separately for each individual drug. A shared infrastructure can also allow for a single set of REMS materials and information about the programme, stated the regulatory authority. Pharmabiz