The emergence in genetic research has generated considerable interest in the role that genetics plays on individual drug responses. Genetic research gathered by companies such as 23andMe has allowed scientists to map out the genetic variation among individuals, and use this information to identify potential biomarkers for disease, drug response, and adverse reactions. This link between genomics and pharmacy is called “pharmacogenomics,” and it has allowed clinicians to prescribe medications which are safer and more efficacious for patients based on their genetic make-up. Although pharmacogenomics is very promising for the clinical world, it is arguably still in its infancy and cannot be relied upon to make a diagnosis or prescription. 

What Benefits Does Pharmacogenomics Offer?

According to one clinician, pharmacogenomics has allowed for new ways of prescribing drugs to patients. Often, certain genetic mutations or deletions will harmfully interact with medication to produce toxicities. By testing the patient’s genotype, however, the clinician can avoid prescribing a medication that could prove dangerous to patients with certain genotypes. One example of this is when testing for the CYP2D6 gene, which allows people to metabolize drugs more rapidly. Clinicians can adjust their drug dose accordingly for people who have few CYP2D6 genes and who may not be capable of metabolizing the drug as quickly as other individuals. Pharmacogenomic testing allows clinicians to tailor their prescriptions to ensure that their treatments meet the patient’s needs on a personalized level. The FDA has recommended genotyping before prescription, particularly because it allows clinicians to choose the safest, most efficacious treatment option for their patients. Although pharmacogenomics allow for more personalized medicine, it may be too early to rely on genotype testing to diagnose diseases or choose medications.

Is Pharmacogenomics Viable in Clinical Practice?

There are many complicating factors that make pharmacogenomics unreliable in a clinical setting. Although pharmacogenomics offers insight into a patient’s predisposition for certain reactions to drugs, there are many environmental factors which make it difficult to establish a clear relationship between genetics and drug response. These factors can include the interaction of other disease states, drug interactions, and gene-environment interactions. This represents a complex interplay of different variables and makes it difficult to pinpoint exactly how a patient might react to a drug based on their genetics. In fact, one study has shown that only 10% to 15% of genetic biomarkers have a direct impact on drug response. This means that pharmacogenomics does not offer clinicians a way to choose treatment plans based on a patient’s genotype. 

What Is the Overall Value of Pharmacogenomics?

Despite the overall promise that pharmacogenomics holds in areas of drug development, it remains less viable in a clinical practice. This is because there are many factors influencing the relationship between genetics and a patient’s reaction to drugs—making pharmacogenomics difficult to rely upon in a clinical setting. 

At the moment, it does not appear pharmacogenomics can translate smoothly into clinical practice because of the scientific barriers it faces. Despite these barriers, pharmacogenomics has the potential to revolutionize the clinical world.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Podcasts or on Apple Podcasts.

Blog Disclaimer

The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.