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FDA Guidance Needed for PGx-Based Dosing Dxs Before MDs Will Adopt Them

NEW YORK (GenomeWeb News) — The US Food and Drug Administration must issue guidelines to help physicians use pharmacogenomic-backed dosing diagnostics before the clinical community can adopt them fully, a draft HHS report has concluded.
Despite clearing Roche’s AmpliChip and including genetic information in the label for Pfizer’s colorectal cancer drug Camptosar, the FDA hasn’t clarified how physicians should use the tests, the HHS Secretary’s Advisory Committee on Genetics, Health, and Society reported last week in the draft report.
“Aside from FDA’s role as market gatekeeper for PGx products, the agency requirements and actions – or the lack thereof – influence the ways in which marketed PGx technologies are used in clinical practice,” according to the draft report, entitled Realizing the Promise of Pharmacogenomics: Opportunities and Challenges. “For example, FDA approval of a PGx test does not necessarily result in dosing guidelines for accompanying therapy.”
Pharmacogenomic-based testing can identify patients who are likely to respond differently to particular drugs and indicate the need for customized dosing, “but that testing does not necessarily translate into dosing instructions,” the report added. “As such, patients will have to be monitored and have their dosing adjusted empirically.”
Since pharmacogenomics is still an emerging field, there is not enough data regarding how its tools can inform clinical decisions such as dose adjustments. The report said the FDA needs help defining these gaps in knowledge.
The HHS group, which began studying the issue in 2005, distilled information from industry representatives, health care providers, and government agencies involved in PGx on a policy level.
Ultimately, the report recommends the FDA work with professional medical organizations to develop dosing guidelines, encourage clinical trials exploring the relationships between diagnostics and drug response, and seek input from stakeholders in industry and academia to translate the findings from prospective studies into treatment guidelines.
The draft report, developed by SACGHS, its PGx Task Force, and the Lewin Group, is available for public comment until June 1. After considering the public’s input, SACGHS will issue a final version in 2008.

The complete version of this article appears in the current issue Pharmacogenomics Reporter, a GenomeWeb Daily News sister publication.

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