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The FDA Roundtable Part II: REMS, Outcomes Studies and Drug Withdrawals

 
• By Ramsey Baghdadi

In Part II of The RPM Report’s roundtable discussion with three top FDA officials, the importance and implementation of FDA’s new REMS authorities, drug withdrawal precedents and the agency’s view of outcomes studies are the focus of the discussion.

How have sponsors been approaching negotiations over drug labeling and risk evaluation and mitigation strategies (REMS)? In what cases does the agency decide to ask for a REMS? What does FDA think of the new cases of a serious side effect associated with Biogen Idec’s multiple sclerosis drug natalizumab (Tysabri)?

Office of New Drugs director John Jenkins, Office of Surveillance and Epidemiology director Gerald Dal Pan and Office of Medical Policy director Bob Temple discussed their views on these questions...

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