FDA Develops Web-Based Resource to Support Pharmacogenetics

The FDA recently announced a collaboration with Radiological Health and Center for Drug Evaluation and Research to develop a web-based resource intended to support the current science in pharmacogenetics. 

The FDA’s new web-based resource includes a table with specific gene-drug interactions which have enough scientific evidence to support the associations between certain genetic variants.

The table will also outline associations between drugs and generic variant-inferred phenotypes, altered drug metabolism, and in certain cases, different therapeutic effects including risks and adverse events, the announcement stated.qua

The table does not include all or the possible gene-drug interactions, but it does include additional gene-drug interactions that are consistent with the current FDA labeling. The literature-based scientific evidence is used to support recommendations in professional guidelines used by clinicians. 

“The table is not complete, but we felt it is important to provide clinicians, patients, and test developers with information now while we continue to review the scientific evidence,” the FDA stated. “We anticipate updating this web-based resource periodically as the evidence evolves.” 

Pharmacogenetic testing is a type of genetic test that may predict how an individual will react to certain medications, which is vital for healthcare providers. But for many medications, there is not enough significant evidence to support using pharmacogenetic test results to inform doctor’s decisions. 

In 2017, the FDA warned the public about firms offering genetic tests that were not supported by the agency or other scientific evidence. Decisions based on inaccurate information can provide patients with harmful medications or give them an inappropriate dosage. 

“All of these scenarios can create unnecessary delays and prevent patients from receiving the timely and appropriate treatment. Patients and clinicians deserve better,” the FDA emphasized. 

For many years, the FDA developed its existing approach to laboratory developed tests (LDTs) when the landscape was different and relied on technologies in local settings. 

Although the landscape has changed, the FDA’s main goal has continued to be to work with Congress on broader legislative solutions on the oversight of in vitro clinical tests which would modernize the regulations. 

But currently, the FDA refuses to stand by when safety issues arise. 

“We believe it is important to take steps not to help ensure that claims are being made for pharmacogenetics tests offered today are grounded in sound science to avoid inappropriate management of patients medications,” the FDA stated. “We do so through approaches that both protect patients and advance the development of analytically and clinically validated pharmacogenetics tests.” 

The FDA welcomes public comments from stakeholders on specific pharmacogenetic associations that should or should not be included in the future. The data will be evaluated as the table continues to be updated. 

The agency is also looking to additional approaches for evaluating the evidence, including a community-based collaborative approach to the ongoing evaluation of the evolving science.

“We will continue to communicate about the promise and potential of pharmacogenetic testing, and about when we have concerns regarding claims that are not supported by sufficient scientific evidence,” the FDA emphasized. “We are committed to engaging with stakeholders as we work to protect patients while fostering the development of new and innovative diagnostics.”