Road Map for REMS - Pharmaceutical Executive

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Road Map for REMS


Pharmaceutical Executive


REMS as Sales Driver

In their capacity to both monitor safety and personalize usage, REMS programs can produce an overall improvement in the value proposition of a brand. Celgene's STEPs program for Thalomid and Revlimid for multiple myeloma and other hematological syndromes and Biogen Idec/Elan's MS drug Tysabri are prime examples. Payers can see the value of a product and opt to cover it if its REMS restricts use for certain diagnosis and patient characteristics.

An effective REMS programs requires the participation of virtually every division in a company, from clinical to regulatory to marketing. This exercise can help to strengthen pharma's new emphasis on building cross-functional teams. Marketing a new drug with a REMS program will transform the launch, as the drug's safety alert and monitoring become a kind of service that differentiates the product from competitors. REMS programs also provide benefits to marketing efforts, such as better prescriber segmentation and preferred prescriber programs and an improved promotional mix with well-defined roles for sales reps, medical science liaisons, speaker's bureaus, and journal ads.

The REMS system, in significant albeit select ways, grants the industry some favors that even the most expensive lobbying could not buy. For one, REMS can offer a drug a kind of market exclusivity. Botox's REMS include a provision that no Botox-like product can be substituted for the cosmetic enhancement. Lilly's blood thinner Effient has a REM ensuring that sales reps get face time with docs to explain the drug's special use. And if a company patents its REMS, generic competition could be shut out of the market unless REMS are waived or they develop their own. Distribution restrictions can also make it difficult for generics to acquire branded products for comparative evaluations, leading to entry barriers.

The primary objective of the REMS program is to improve the safety of, and trust in, pharmaceutical products. REMS programs can protect patients, educate providers, and improve the reputation of the FDA and the industry alike. Because the system presents drugmakers with additional regulatory responsibilities, some heavy lifting will be required and new capabilities developed. In the evolving REMS landscape, FDA and pharma are learning simultaneously; in order to minimize uncertainty companies is advised to constantly assess the challenges and find ways to manage them. Yet it should be clear that more than a few gains will also come pharma's way. In addition, REMS can provide significant opportunities to enhance the value of the brand, including improved probability of approval. If successful, then, REMS will finally lay to rest the notion that safety comes at the expense of innovation, speed, and cost. And that will be good news for everyone.

Thani Jambulingam is the chair of, and an associate professor at, the department of pharmaceutical marketing at St. Joseph's University. He can be reached at


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