This post was drafted by Innovative Science Solutions and Wendell S. Fortson, founder of Fortson Strategies, LLC. Fortson Strategies is a national cancer litigation strategy firm for corporations. The firm’s focus is oncology-related matters involving patent, toxic torts and products liability litigation.
It is well-established that not every individual responds the same way to a pharmaceutical drug. This is largely because our genes, just like they determine the color of eyes, also play an important role in determining how we respond to medications. There are many cases of drugs that are now contraindicated in individuals with a certain genetic makeup. These genetic markers (often referred to as pharmacogenomic biomarkers) are increasingly being incorporated into drug labeling which can describe (among other information):
- Risk for adverse events
- Drug exposure and clinical response variability
- Genotype-specific dosing
Thus, genetic markers add a whole new dimension to adverse drug reaction reporting. Pharmacogenomic (PGx) biomarkers are genetic variants (e.g. DNA) associated with drug efficacy and safety. PGx biomarker information can be used to inform physician prescribing decisions including optimal dosing to minimize the risk of a serious adverse events. Approximately 10% of FDA approved drugs, however, have PGx biomarker data in the label. Because of this, there has been a concentrated effort to identify novel PGx biomarkers that are associated with FDA approved therapies but that may not be included in the label (e.g., eMERGE Network).
Revolution in Molecular Biology is Generating Massive Amounts of New Information
The ongoing revolution in molecular science is generating new pharmacogenomic information at a staggering pace. This means that that drug manufacturers are more frequently at increased risk of litigation because they were not aware of new developments in science. For instance, the Electronic Medical Records and Genomics (eMERGE) Network is a NIH funded consortium of biomedical research institutions. One goal of eMERGE is to validate and integrate PGx biomarker information into patients’ electronic health records. To date, eMERGE has screened over 500 therapeutic products to identify their associated PGx biomarkers. This information is publicly available on Sequence and Phenotype Integration Exchange (SPHINX)-a web-based PGx search tool.
We suspect that many of the therapies listed in SPHINX and their associated PGx data might not be in included in the labels. As a result, eMERGE’s efforts inherently, albeit unintentionally, increases the risk of “pharmacogenomics-inspired litigation” for drug manufacturers.
Case Study: Plavix
Plaintiffs in the Plavix litigations (see link, link, link) claim that the defendants failed to update the Plavix drug label in a timely fashion with pharmacogenomic biomarker information. Specifically, plaintiffs claim that approximately 30% of patients administered Plavix express a genetic variation of the CYP2C19 gene that makes them poor metabolizers of the drug. As a result, plaintiffs claim they experienced serious adverse events or received little benefit from the drug.
Based on these claims, plaintiffs, in this case, seek compensatory damages, punitive damages, and disgorgement of profits from the sale of Plavix.
Proactively Mitigate Risk Of Pharmacogenomics-Inspired Litigation
Attorneys and their drug manufacturer clients can proactively mitigate the risk of pharmacogenomics-inspired litigation risk in several ways. Most importantly, it is critical to systematically monitor new scientific developments relevant to drug development. These newly published scientific studies will provide key information relevant to lack of efficacy claims based on individual pharmacogenomic markers. Only by having a clear handle on new pharmacogenomic findings can drug manufacturers hope to effectively confront allegations related to pharmacogenomic markers in individual drug consumers. In addition, it is critical for counsel to work with their pharmacovigilance experts and marketing and manufacturing clients to review their drug discovery programs for information that could be relevant to pharmacogenomic-based warnings, the potential for adverse drug reactions, and to develop the right strategy should litigation risk arise.
ISS partners with life sciences companies to mitigate their pharmacogenomics-inspired litigation risk. We do this by helping them integrate pharmacogenomics “best practices” into their drug discovery, development and commercialization processes.
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