Financial backers have started to demand post-marketing control plans from companies seeking funding. Risk Evaluation and Mitigation Strategy (REMS) planning has become an increasingly important consideration for venture capital (VC) firms, 18 months after its introduction by the Food and Drug Administration Amendments Act (FDAAA) of 2007. The FDA can require manufacturers to submit a REMS—a plan to manage known or potential risks associated with a drug or biological product—when a drug first comes on the market, or later. From an investor's perspective REMS can expedite approval and extend a product's market exclusivity, and Gary Patou of MPM Capital in San Francisco, has identified it as one of the standard requirements his firm expects from applicants. Steven Burrill of investment bank Burrill & Company in San Francisco, agrees. “We make sure REMS are a part of the decision because getting into the market and getting paid are important.” But Burrill does not believe REMS are prompting companies to think about regulatory approval any earlier in development—companies have always been expected to do this. Burrill believes comparative effectiveness studies—in which one drug is pitted against another—will be a major consideration for investors because it is a significant concern with lawmakers at the moment.