Search Results for 'REMS'

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Product: Lotronex®(alosetron) Tablets
Company: Prometheus
Petition Filer: Prometheus
Petition Number(s): 2013P-0572
Date of Petition: May 28, 2013
Responding Petitions:

Issue and Implication: Whether the current REMS program system is sufficiently described for manufacturers to work with ANDA applicants on a shared REMS program.

Action Requested by Petitioner: The Petitioner is asking FDA to provide guidance and clarity on how to implement shared REMS programs, and if any ANDA applicant is requesting a waiver for Lotronex, that it be notified of the request.

Summary of Petition(s): Back in 2000, FDA approved Lotronex for the use in irritable bowel syndrome. While an efficacious product, it was perhaps overprescribed which led to a series of adverse events, and FDA pulled it from the market. After negotiations with FDA, FDA permitted it back on the market with a REMS program that include physician certification, patient education, and limited distribution. Petitioner is now the manufacturer of the product and has been in Paragraph IV litigation with an ANDA filer Roxane.

Petitioner would like clarity regarding “shared REMS programs.” In 2007 amendments of the Food and Drug Administration Act, the Act provided more description of REMS programs and contemplates a “shared system” for drugs that are available in brand and generic form. While never defined, the concept behind the shared system is that all manufacturers of the drug would share the same REMS program. The benefit is to have the same REMS program in place and to have seamless transitions when patients start receiving the generic product. The Act also allows ANDA applicants to get a waiver that would relieve them of any duty to provide a REMS program.

Petitioner points out that the Act, nor FDA, ever really sets out parameters or guidance of exactly how this works. In theory, it would require the brand and ANDA applicant to meet and negotiate over the program, share the costs of the program, and enforce each other’s behavior during the program. But the FDA has never provided any guidance as to who shares what costs and how this avoids antitrust scrutiny. It also does not provide any notice to the brand if the ANDA filer wants to obtain a waiver. So, Petitioner asks FDA to provide this guidance which would not only help in this particular situation but also for all future REMS products.

FDA Action: On October 18, 2013, FDA granted/denied this petition. The effect of the action was to deny the material requests made in the Petition.

Citizen Petition
FDA Action

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