Companies that fail to follow Risk Evaluation and Mitigation Strategies (REMS) can face fines of up to $10 million, according to a new draft guidance released by the US Food and Drug Administration (FDA). The document released on September 30 is the most extensive guidance for industry regarding postmarket management of drug risks since REMS was established under the FDA Amendments Act of 2007 (FDAAA) (Nat. Biotechnol. 25, 1189–1190, 2007). The guidelines specify the content the agency expects companies to submit in a REMS proposal and the fines for not meeting REMS requirements, which can add up to $10 million. On a practical level, the new guidance has the potential to delay a drug's approval process. For BioDelivery Sciences, in Raleigh, North Carolina, the agency's request for a REMS program had a major impact. The legislation was enacted as the FDA was reviewing their first drug, Onsolis (fentanyl buccal), for the management of cancer pain. Complying with REMS requirements delayed product approval for nearly a year. Nonetheless, Al Medwar, vice president of marketing and corporate development at BioDelivery says, “I completely support the FDA's ability to enforce this as necessary, including imposing fines on those who don't comply. For too long, the FDA has not had adequate ability to enforce the regulations put in place,” he says.