Pharmacogenomics: Post-Drug Development

Pharmacogenomics is the study of genes and how they impact drug response in certain individuals. This information allows physicians to customize treatment plans for their patients by taking into account a patient’s genetic unique background. The emerging technologies that have resulted from pharmacogenomics have changed the structure of drug development and FDA regulatory law. Pharmaceutical companies should stay informed about these changing regulations to ensure that their drug products can successfully stay on the market and meet new legal guidelines.

Will the FDA Use Pharmacogenomic Data?

As pharmacogenomics changes the drug development process, the FDA must adapt its approval process to reflect these changes. Pharmacogenomic testing allows companies to determine which patient populations will respond adversely to a drug and therefore avoid potential harm. This is valuable information for the FDA, particularly when protecting patient health. According to Kate Merton, Head of Commercial Development at Navigate BioPharma, the FDA will approve drugs based on the best data available to them, which includes pharmacogenomic testing. They may investigate whether companies have done studies into pharmacogenomics and if the right patient populations were being targeted. For example, if a pharmaceutical company targeted a population that should not be receiving a drug, the FDA may step in and enforce a black box warning. The FDA may issue a warning that highlights adverse drug reactions when patient safety is at risk. Pharmacogenomics allows the FDA to implement even better guidelines to protect patient safety and ensure that drugs do not harm patients.

How Will the Drug Approval Process Change?

As pharmacogenomics becomes more widely used, the FDA may require companies that have already gone through the approval process to re-examine their drugs. This may involve going back and performing more pharmacogenomic testing to ensure that they are targeting the correct patient populations. Companies may also have to undergo a “sifting process,” according to Ms. Merton, and examine retrospective data to identify drugs that may cause adverse reactions in patients. For potentially harmful drugs, it is helpful to go back and ensure that patients are not at risk for health problems such as cardiovascular events. To provide evidence that a drug is safe, companies should perform a pharmacogenomic test and show that patients at risk are not being exposed to the drug. This sifting process may end up saving companies money, particularly because pharmacogenomic tests prove far cheaper than running clinical studies. 

Weighing the Costs of Clinical Studies

Determining whether to run a clinical study is yet another consideration facing pharmaceutical companies. Companies should ideally perform pharmacogenomic testing to ensure that their drugs do not have the potential to harm patients. These tests would reveal the subset of patients who should not be taking the drug and potentially guard the company against class action lawsuits. If there is no testing, however, companies risk exposing themselves to lawsuits from patients harmed by their drugs. A lawyer representing a plaintiff may say that the drug contained a “design defect,” and that the company did not adequately protect patients taking its drug. If there is substantial evidence suggesting that a drug may harm a certain group of patients, pharmaceutical companies should conduct a clinical trial to ensure patients are being protected. 

The impact that pharmacogenomics has had on drug development not only means a change in FDA protocol, but it also requires pharmaceutical companies to inspect the safety of their drug products. It may be helpful to consult with a lawyer with a background in FDA regulatory law to ensure that drugs comply with FDA laws in new pharmacogenomic data.

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.

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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.