Aug 25 2009
While many pharmaceutical and biologics companies are getting accustomed to FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs for many new and old drugs, most are not adequately preparing for the equally mandatory program evaluations beginning just 1-1/2 years after each REMS is put into effect.
That warning has been issued by risk management expert Jeffrey Fetterman, CEO of ParagonRx, a Delaware-based company specializing in optimal medication use, in a blog posted to the company's Website.
"FDA requires an assessment of REMS performance at intervals no less frequently than 18 months, 3 years and 7 years post launch," Fetterman says. On the blog, he asks: "Your company wouldn't launch a new product line and wait for the end-of-the-year results before assessing whether the launch was effective, correct? So why would tracking and adjusting risk management activities be any different?"
Fetterman goes on to recommend techniques to manage the effectiveness of REMS and to achieve program targets.
The first? An approach of "performance; no excuses," Fetterman advises.
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