PHARMACY

FDA report delves into personalized medicine

BY Alaric DeArment

SILVER SPRINGS, Md. — Earlier this year, the Food and Drug Administration approved a new drug for treating cystic fibrosis for patients who have a specific genetic mutation, but that also treats the underlying cause of the disease rather than the disease itself.

That drug, Vertex Pharmaceuticals’ Kalydeco (ivacaftor), along with cancer drugs for patients whose tumors have specific genetic characteristics identified by a companion diagnostic test, are examples of personalized medicine. Personalized medicine, in which medical treatments are tailored to patients’ individual characteristics, is a growing field and the subject of a new report by the FDA designed to provide a framework for regulating it.

"For the first time, it provides a compendium of FDA’s many recent efforts to advance regulatory standards, methods and tools in support of personalized medicine and to further refine critical regulatory processes and policies in order to bring about personalized medical product development," FDA commissioner Margaret Hamburg wrote in a forward to the report.

 

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Review supports pharmacogenomic testing for some psychiatric drugs, Assurex Health says

BY Alaric DeArment

MASON, Ohio — A personalized medicine company said a new study justifies clinical use of pharmacogenomic testing to help predict patients’ response to psychiatric medications and improve treatment outcomes.

Assurex Health said a review published in the International Review of Psychiatry provides "substantial evidence" that pharmacogenomic testing — which is analysis of how patients’ genetic makeup affects their response to drugs — has clinical value in predicting how individual patients will tolerate and respond to specific psychiatric drugs. The review, titled "Clinical Validity of Cytochrome P450 Metabolism and Serotonin Gene Variants in Psychiatric Pharmacotherapy," reviewed published data collected since 2007.

Furthermore, Assurex said, the findings refute results of a previous assessment of pharmacogenomic testing in 2007 by the Evaluation of Genomic Applications in Practice and Prevention initiative, which concluded there was insufficient evidence to determine the value of pharmacogenomic testing for adults starting treatment on certain antidepressants.

"A review of 294 scientific studies published since the EGAPP report clearly demonstrates the clinical validity of multiple genes in predicting patient responses to antidepressant medications," lead study author and Assurex chief science officer C. Anthony Altar said. "This assessment is further supported by multiple clinical trials demonstrating that understanding variations in these same genes leads to better treatment decisions and better patient outcomes."

 

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FDA issues plan to reduce drug shortages

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration is using long-term strategies to address drug shortages when they appear and requiring manufacturers to notify the agency if a shortage is at risk of happening, under a new plan announced Thursday.

The FDA said it would take two actions to improve its efforts to prevent and resolve drug shortages, which have become a problem in recent years, though an executive order by president Barack Obama two years ago reduced the number of shortages in 2012 to 117, from 2011’s 251. The agency said it was able to prevent 195 shortages in 2011 and 282 in 2012.

First, the agency will release a strategic plan for improving its response to imminent or existing shortages and longer-term approaches for addressing the underlying cause of shortages, as mandated by the Food and Drug Administration Safety and Innovation Act of 2012, also known as FDASIA. The plan includes launching a new smartphone app that would allow consumers to instantaneously access drug shortage information; clarify manufacturers’ roles and responsibilities by encouraging them to take steps to reduce the likelihood of shortages; and update the FDA’s internal procedures for responding to early notifications of potential shortages. Other provisions in the plan would allow broader use of manufacturing metrics to evaluate manufacturing quality, such internal organizational changes as a proposed Office of Pharmaceutical Quality within the FDA’s Center for Drug Evaluation and Research and risk-based approaches for identifying early warning signals of manufacturing and quality problems.

Second, a proposed rule would require all manufacturers of certain medically important prescription pharmaceutical and biologic drugs to notify the FDA of a permanent discontinuance or temporary interruption of manufacturing that is likely to disrupt supply. The rule would implement an expanded early notification requirement included in FDASIA. The FDA said early notification would allow it to work with manufacturers to investigate issues leading to manufacturing disruption, identify other manufacturers that can make up for the shortfall and expedite inspections and reviews of regulatory approval applications for products that might prevent or mitigate a shortage.

"The complex issue of drug shortages continues to be a high priority for the FDA, and early notification is a critical tool that helps mitigate or prevent looming shortages," FDA CDER director Janet Woodcock said. "The FDA continues to take all steps it can within its authority, but the FDA alone cannot solve shortages. Success depends upon a commitment from all stakeholders."

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