Search Results for 'REMS'

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Issue: Risk Evaluation and Mitigation Strategies (REMS)
Petition Filer: Kaiser Permanente
Petition Number(s): 2009P-0601
Date of Petition: January 4, 2010
Responding Petitions: Amylin Pharmaceuticals

Issue and Implication: Whether FDA has acted in accordance with the Federal Food, Drug, and Cosmetic Act, Section 505-1.

Action Requested by Petitioner: Petitioner makes several requests. In short, it asks FDA to follow the FDCA by allowing physician input into REMS policy, and specifically towards products. In addition it requests that annual REMS product reviews take place to see whether the REMS plans are effective.

Summary of Petition(s): The FDCA allowed for certain products to undergo REMS procedures to ensure safe and effective handling and use. The Act contemplates that there would be a transparent procedure and ample opportunity for health care professionals to provide information and help craft strategies. In addition, there are additional provisions allowing for periodic review of such REMS procedures.

Petitioner asserts that FDA tends to implement REMS policies without fully following the FDCA. Petitioner claims also that some of the REMS procedures place undue burdens on health care delivery systems. As such, it requests that FDA allow for more transparency in its decision-making and allow for more industry input before developing and implementing REMS procedures.

On April 21, 2010, Amylin Pharmaceuticals submitted a short response. Amylin fully supports the petitioner’s arguments and emphasizes that the entire REMS procedure should be more transparent, occur sooner in the process (during clinical phase II), and allow for more robust input from interested parties.

FDA Action: Pending.

Citizen Petition
Amylin Response

Issue: Risk Evaluation and Mitigation Strategies (REMS)
Petition Filer: Roxane
Petition Number(s): 2010P-0076
Date of Petition: February 18, 2010
Responding Petitions: Hoffman La Roche, Novartis

Issue and Implication: Whether the Federal Food, Drug, and Cosmetic Act, Section 505-1 requires FDA to allow approved generics to develop REMS policies.

Action Requested by Petitioner: Petitioner makes a simple request: when an ANDA has been approved, the FDA must allow the generic(s) to help develop a REMS policy that FDA requires both brands and generics to follow.

Summary of Petition(s): Roxane submitted this petition after the following occurred. Back in July 2008, FDA approved Roxane’s ANDA for Cellcept®(mycophenolate). By September of that year, FDA concluded that a REMS policy should be developed for this product. So, it solicited comments and proposals from the two brand manufacturers Roche and Novartis (manufacturer of Myfortic). Over the next few months, a REMS policy was developed even though Roxane had no knowledge of it and the generic products accounted for over 50% of the volume sales. Roxane first learned of the REMS policy in May 2009 when Roche presented Roxane an “option” of participating in the REMS program by paying for a portion of Roche’s costs in developing the program.

Roxane makes a simple fairness argument: it states that common sense application of section 505-1, the REMS section, would suggest that all manufacturers affected by a REMS policy – that is, one that FDA would require them to follow – should be allowed to provide input and opinion as to how and what would be required. After all, if a generic needs to bear the cost of a REMS policy, it should have the right to offer ideas, solutions, and help develop the policy.

On April 12, 2010, Hoffman-La Roche offered a response. It simply argues by stating that the petition process is merely going to delay the implementation of the REMS program which is near completion. It also recharacterizes the facts. Hoffman La Roche said that it just followed what FDA recommended – that it develop a REMS program and when told by FDA to inform generic manufacturers, it contacted Roxane who refused to participate at that point.

On May 12, 2010, Novartis filed a comment requesting that the petition be denied in its entirety. Novartis states that the REMS statute has been followed to the letter of the law and that Roxane has some critical facts incorrect. Novartis states that FDA had contacted Roche and Novartis to develop a REMS plan long before Roxane was approved. Hence, the plans were already in place, and Roxane could not have given any significant input at that stage. Novartis also states that the Roxane requests do not follow the law or are not viable policies.

FDA Action: On January 12, 2016, Petitioner withdrew this petition.

Citizen Petition
Hoffman La Roche Response
Novartis Response
Petition Withdrawal

Issue: Risk Evaluation and Mitigation Strategies (REMS)
Petition Filer: Holland & Knight, a law firm
Petition Number(s): 2011P-0801
Date of Petition: November 8, 2011
Responding Petitions:

Issue and Implication: Whether REMS regulations can be applied towards Research Materials.

Action Requested by Petitioner: The Petitioner is asking FDA to clarify REMS regulations and policies regarding Research Materials and to take no enforcement actions regarding Research Materials and pertaining to REMS.

Summary of Petition(s): The petitioner discusses the application of the problem regarding Revlimid®(lenalidomide). Because of the compound has known teratogen effects, the FDA implemented a REMS program for this product. The restrictions are that the product must be prescribed and dispensed within the confines of the RevAssist REMS program. Along with other companies, petitioner is a manufacturer of lenalidomide for use as a research material. The sale of the powder form (which is not in finished form) is intended for use in laboratories and not for clinical use in humans or animals. Celgene, the maker of Revlimid, has challenged the sale of the product as a research material as it has not gone through the REMS program.

Petitioner is asking FDA for clarification regarding this circumstance. Specifically, it argues that the statutory and regulatory readings lead to a conclusion that the REMS program is not applicable to research materials that are not intended for clinical use or human consumption.

FDA Action: On January 17, 2012, Petitioner withdrew this petition.

Citizen Petition
Petition Withdrawal

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