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REMS represent big change for industry

Pharma Compliance Alert, September 24, 2008

Risk Evaluation and Mitigation Strategies (REMS) could represent the biggest change to drug regulation in decades. And it raises difficult compliance challenges for the pharmaceutical industry, says Meredith Manning, JD, a partner at Hogan and Hartson, in Washington D.C. during the Regulatory Affairs Professionals Society annual seminar September 14-17 in Boston.

REMS allow the FDA to mandate restricted distribution of pharmaceutical products. The FDA may require post-marketing studies for some products under REMS or may require the pharmaceutical company to change the label.  

The FDA can require a company to put REMS in place if the agency determines REMS is needed to ensure the benefits of the product outweigh its risks. REMS can require a product only be used in certain settings, by healthcare providers with particular training, or administered to patients who are monitored or enrolled in a registry. The FDA can require the use of certain risk minimization tools, can monitor their effectiveness, and can oversee the way those tools are used.

The FDA looks to see if a drug or biologic is used in a certain way and pharmaceutical companies are now responsible for ensuring third parties administer and use certain drugs properly. Manning advises companies to put systems in place to ensure compliance with REMS.

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