Risk Evaluation and Mitigation Strategy (REMS): A Short Critique
Risk Evaluation and Mitigation Strategy (REMS): A Short Critique
The abuse of prescription medications has increased over the last decade to the level that many have described as epidemic. The apparent increase in abuse, misuse, overdose, and deaths in the last decade is impressive and alarming. As a result of intense media attention, an amendment to the Food, Drug and Cosmetic Act was enacted in 2007, giving the US Food and Drug Administration (FDA) a mandate to require drug sponsors to implement specific measures to reduce safety risks. With the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA had the authority to require New Drug Applications to include a proposed Risk Evaluation and Mitigation Strategy (REMS). The FDAAA also authorized the FDA to require holders of certain drug applications already approved without a REMS to submit a proposed REMS if the agency became aware of new safety information. In February 2009, the FDA notified manufacturers of 24 branded and generic opioid products that they would be required to submit a REMS. Manufacturers of hydrocodone-combination products -- the most frequently prescribed and abused category of opioids -- as well as combination oxycodone products are not included. Since December 8, 2009, the FDA had approved 95 REMS, including 5 for analgesics.
The current goal the FDA seeks is a classwide REMS program that would be applicable to most schedule II opioids. To assist in developing this REMS program, the FDA established an Industry Working Group (IWG). The IWG and the FDA have been committed to developing a REMS that would include a medication guide, patient information materials, and "safe use" materials and programs. To further clarify how a REMS program should be designed, the FDA engaged in a number of stakeholder meetings in which they elicited feedback and suggestions concerning the development of REMS from an impressive array of organizations and individuals. Interestingly, there seemed to be an overriding notion that REMS could be a positive and constructive tool to help reduce the nonmedical use of scheduled medications. The FDA claims that "we have brought a proposed REMS for long-acting and extended-release opioids intended to reduce misuse and abuse, overdose and death to this Advisory Committee." The FDA has, in the opinion of this author, failed to seriously consider many of the recommendations by stakeholders and in its current format, the REMS contains content similar to that proposed by the IWG and FDA last year -- that is, medication guides, patient information materials and safe use material and programs.
Risk Evaluation and Mitigation Strategy: A Short Critique
The abuse of prescription medications has increased over the last decade to the level that many have described as epidemic. The apparent increase in abuse, misuse, overdose, and deaths in the last decade is impressive and alarming. As a result of intense media attention, an amendment to the Food, Drug and Cosmetic Act was enacted in 2007, giving the US Food and Drug Administration (FDA) a mandate to require drug sponsors to implement specific measures to reduce safety risks. With the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA had the authority to require New Drug Applications to include a proposed Risk Evaluation and Mitigation Strategy (REMS). The FDAAA also authorized the FDA to require holders of certain drug applications already approved without a REMS to submit a proposed REMS if the agency became aware of new safety information. In February 2009, the FDA notified manufacturers of 24 branded and generic opioid products that they would be required to submit a REMS. Manufacturers of hydrocodone-combination products -- the most frequently prescribed and abused category of opioids -- as well as combination oxycodone products are not included. Since December 8, 2009, the FDA had approved 95 REMS, including 5 for analgesics.
The current goal the FDA seeks is a classwide REMS program that would be applicable to most schedule II opioids. To assist in developing this REMS program, the FDA established an Industry Working Group (IWG). The IWG and the FDA have been committed to developing a REMS that would include a medication guide, patient information materials, and "safe use" materials and programs. To further clarify how a REMS program should be designed, the FDA engaged in a number of stakeholder meetings in which they elicited feedback and suggestions concerning the development of REMS from an impressive array of organizations and individuals. Interestingly, there seemed to be an overriding notion that REMS could be a positive and constructive tool to help reduce the nonmedical use of scheduled medications. The FDA claims that "we have brought a proposed REMS for long-acting and extended-release opioids intended to reduce misuse and abuse, overdose and death to this Advisory Committee." The FDA has, in the opinion of this author, failed to seriously consider many of the recommendations by stakeholders and in its current format, the REMS contains content similar to that proposed by the IWG and FDA last year -- that is, medication guides, patient information materials and safe use material and programs.
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