The AAPS conference regarding extended or modified release formulations of drugs and therapeutic equivalence raised many important public policy questions. The AAPS conference material noted that:
"Demonstration of bioequivalence (BE) between drug products can be made using blood level measurements, pharmacodynamic studies, clinical trials, and/or in
vitro studies. The US regulations deem drug products therapeutic equivalents (TE) if they are both pharmaceutically equivalent and bioequivalent."
But it became clear that current standards of BE do not add up to TE because we know more about the impact of individual variation in how we absorb and process drugs now than when the generic drug reforms were enacted in 1984. So the question is, as Kamal Midha, Ph.D. of University of Saskatchewa, who spoke about existing standards for TE of sustained release products: are current regulations for measuring BE enough?
More to the point: if the public and the FDA are demanding more evidence about the safety and reliability of new products pre and post market (including more information the pharmacodynamics and phamacokinetics of such products), why shouldn't such information be used to establish TE of generic products, particularly those where the amount of a drug released and when is essential to a drug's safety and effectiveness. While it may be true that this issue only affects a handful of drugs, it is also true that these drugs are not only widely prescribed, they are also mostly prescribed in generic form. And post market oversight of this growing market share is not a top FDA priority even as safety has become an critical (path) FDA concern,
So at the end of the day (and the conference) it became clear that better standards for tracking the impact of modified release products with new tools is not to be ignored. Rather than being a way for innovators to escape generic competition, the collection and monitoring of better measures of TE can improve the overall quality of medicines without significant costs to either part of the industry. That is the goal and essence of the Critical Path. To ignore or dismiss concerns about toxicity or adverse events of sustained release products because they are made by generic companies is to suggest that the financial interests of that industry is more important than the public health.
This issue can, as the AAPS meeting demonstrated, can be explored in a way that uses science to clarify issues and stratify risk so that the most important public health issues relative to this product class can be addressed.
"Demonstration of bioequivalence (BE) between drug products can be made using blood level measurements, pharmacodynamic studies, clinical trials, and/or in
vitro studies. The US regulations deem drug products therapeutic equivalents (TE) if they are both pharmaceutically equivalent and bioequivalent."
But it became clear that current standards of BE do not add up to TE because we know more about the impact of individual variation in how we absorb and process drugs now than when the generic drug reforms were enacted in 1984. So the question is, as Kamal Midha, Ph.D. of University of Saskatchewa, who spoke about existing standards for TE of sustained release products: are current regulations for measuring BE enough?
More to the point: if the public and the FDA are demanding more evidence about the safety and reliability of new products pre and post market (including more information the pharmacodynamics and phamacokinetics of such products), why shouldn't such information be used to establish TE of generic products, particularly those where the amount of a drug released and when is essential to a drug's safety and effectiveness. While it may be true that this issue only affects a handful of drugs, it is also true that these drugs are not only widely prescribed, they are also mostly prescribed in generic form. And post market oversight of this growing market share is not a top FDA priority even as safety has become an critical (path) FDA concern,
So at the end of the day (and the conference) it became clear that better standards for tracking the impact of modified release products with new tools is not to be ignored. Rather than being a way for innovators to escape generic competition, the collection and monitoring of better measures of TE can improve the overall quality of medicines without significant costs to either part of the industry. That is the goal and essence of the Critical Path. To ignore or dismiss concerns about toxicity or adverse events of sustained release products because they are made by generic companies is to suggest that the financial interests of that industry is more important than the public health.
This issue can, as the AAPS meeting demonstrated, can be explored in a way that uses science to clarify issues and stratify risk so that the most important public health issues relative to this product class can be addressed.
