Search Results for 'REMS'

[gregoryglass]

Issue: Prevent the Use of REMS to Block Generics
Petition Filer: Dr. Reddy’s Lab
Petition Number(s): 2009P-0266
Date of Petition: June 15, 2009
Responding Petitions: Celgene

Issue and Implication: Whether brand companies are using Risk Evaluation and Mitigation Strategy (REMS) to delay or block generic entry by refusing to provide product samples to generics to test for bioequivalence.

Action Requested by Petitioner: Petitioner is asking FDA to issue a Compliance Document or Guidance Document to establish a procedure by which a generic company can obtain product samples to test its generic product with the potential reference list drug. Along with this, it is asking FDA to enforce provisions of the FDC Act to ensure that brand companies are complying with its provisions and to further forward any complaint of non-compliance to the Federal Trade Commission for review.

Summary of Petition(s): Dr. Reddy’s states that it has had some troubles getting product samples from brand companies. In refusing to give the samples, the brands have stated that the product is a REMS product and that it is not required to provide the samples. Typically, the generic can get samples on non-REMS from drug channels such as wholesalers. However, it often cannot for REMS products, and the generic company needs to get the sample from a restrictive distribution channel including the brand company.

The FDA Act and its progeny allow for REMS products to ensure product safety. In addition, the provisions specifically state that the REMS status cannot be used to delay generics. Dr. Reddy’s requested Celgene to provide samples of Revlimid®(lenalidomide), but Celgene refused. Dr. Reddy’s also states that Celgene delayed or blocked Barr from getting samples of Thalomid®(thalidomide). Petitioner also states that the number of REMS products is increasing which adds to the possibility of more abuse of REMS status and blocking of generics. Given these facts, Dr. Reddy’s concludes that REMS status is being used as an excuse to delay generics and that FDA needs to enforce the law and create stronger guidance.

On October 9, 2009, Celgene submitted a response stating that there is no legal mechanism to require Celgene, or any other brand company, from selling its product to a generic company for testing purposes. In fact, the law rejects that process. In addition, the request opens up the brand compoany to legal liabilities if the petition is granted.

FDA Action: On August 9, 2013, FDA granted and denied this petition. It granted the portions of the petition asking FDA to clarify a procedure to allow a generic to conduct bioequivalence testing for a REMS product. It also agreed to notify the Federal Trade Commission if it feels that a sponsor of a REMS product is trying to block competition. However, it denied the remaining requests including the request for a provision in the REMS program to not use REMS to delay a generic and the request to ensure sponsors provide REMS product for bioequivalence testing.

Citizen Petition
Celgene Response
FDA Action

©2013 Parry Ashford Inc