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The Clozapine REMS Debacle

10/22/2015

Ten days after launch not only can many physicians who need to register to assure their patients access to this near miracle drug for schizophrenia not do so, but representatives of REMS and FDA refuse to provide information about those accountable.

FDA authorizes or orders pharmaceutical companies to form Risk Evaluation and Mitigation Strategy programs, purportedly to minimize adverse outcomes related to use of certain approved drugs. In the case of clozapine, which rarely causes life threatening blood disorders, patients’ prescriptions have always required regular blood tests. Soon, pharmacies will only dispense prescriptions ordered by prescribers who have passed a perfunctory knowledge test. But the clozapinerems.com web site failed from the launch on Oct. 10, leaving many physicians, myself included, unable to complete the process or even to log in, REMS claims to the contrary notwithstanding: “The known technical issues with the online certification process have been resolved on the Clozapine REMS Program website”. I wish. Attempts to obtain support have resulted in hours on hold and no solution for me.

Who can we hold accountable for this debacle? Neither pharma nor the FDA wants taxpayers to know. REMS support representatives pretend ignorance, admitting only that the manufacturers support the program. They refuse to provide names or information about the nature of the entity. Corporation? Partnership? 

McKesson owns the domain and claims to administer REMS programs as part of its business.

Even my Congressman, Adam Smith, has not responded to my requests for information.

I believe in free enterprise, and trade secrets, but FDA should maintain some semblance of transparency to stakeholders and taxpayers.

I have filed a freedom of information act request and will keep you posted.

Of course, the big question remains: Will patients suffer interruptions in their treatment as a result of mismanagement and negligent Web design?