September 21, 2010
It has come to our attention that in recent weeks many prescriptions for Metanx® have been switched to an alternative product called Neurpath-B. We believe these products have been linked in error. You should understand that the samples of Neurpath-B that Pamlab has examined are not equivalent to Metanx®.
Acella Pharmacueticals began production of Neurpath-B earlier this year. Tested samples of this product contained a Chinese source of folate rather than the active form of folate (used in Metanx®). Unfortunately, the pharmaceutical listing services and major U.S. wholesalers have linked the Neurpath-B product to Metanx® as “generic”. In turn, many pharmacies began to stock Neurpath-B and to substitute that product when filling Metanx® prescriptions.
We believe such substitutions are not based on sound pharmaceutical principles and are not in the best interests of Metanx® patients.
Acella has presented no information to show that Neurpath-B is bioequivalent to, and thereby substitutable for, Metanx®. On the contrary, the Neurpath-B label states that it is not included in the Orange Book (official FDA listing of approved generic drugs), and specifically disclaims therapeutic equivalence to any other product. (see pdf photos)
Pamlab has taken several steps to correct this situation.
• A false advertising lawsuit has been filed against Acella in Federal Court.
• Informational letters have been sent directly to retail pharmacists.
• The news media has been alerted.
• Full updates on product testing have been posted to www.readitfirst.info
We regret the confusion this situation may have caused. To this point, Acella has done nothing to dissuade the listing services from linking Neurpath-B as a generic for Metanx®. Even the pricing is set to mimic Metanx® – the cost of Neurpath-B to monthly cash patients is approximately 10% less than the typical price of Metanx®.
We seek to clarify and inform. Physicians prescribing Metanx® should know that their patients may not be getting the product as prescribed. Patients should be cautious if told that a “generic” is available – no true generic has yet been introduced in the U.S. marketplace.
Thank you for your attention to this matter.
President and CEO, Pamlab LLC