“Right Drug Dose Now” Act Should Help Implement Better Precision Medicine

“Right Drug Dose Now” Act Should Help Implement Better Precision Medicine

The “Right Drug Dose Now” Act was introduced this week by Representatives Tom Emmer (MN-06) and Eric Swalwell (CA-15) to better enable pharmacogenetic testing to prevent adverse drug events and encourage the use of therapies tailored to a patient’s genetic makeup.

The metabolism of drugs is dependent on drug metabolizing enzymes produced by the body, which vary in makeup considerably from person to person depending on their genetics. Genetic variants in genes encoding these enzymes can influence the way drugs are processed by the body and in some people a seemingly normal drug dose can cause a serious reaction because of their genetics. Data show that a patient dies every two minutes from poorly optimized therapy at a cost of over $528 billion per year.

For similar reasons, some medicines can have a very beneficial effect on a subsection of patients with a specific condition, such as cancer, but not others. An increasing number of drugs are now being developed that rely on certain mutations being present to treat a condition. For example, Herceptin (trastuzumab) to treat HER2-positive breast cancer.

Enacting of the Right Drug Dose Now bill will involve updating of the National Action Plan for Adverse Drug Event Prevention to add educational information on how adverse drug events can be reduced through the use of pharmacogenetic testing and also to update electronic health records with pharmacogenomic information to help healthcare providers better understand the link between genetics and drug metabolism when prescribing.

“For too long, patients and providers have been reliant on a ‘test and see’ approach to prescribing pharmaceuticals,” said Emmer in a press statement. “At best, this method is imprecise, and at worst, risks harmful patient outcomes. Every person’s unique genetic make-up affects drug efficacy, absorption rate, dosage and as a result, patient safety. Pharmacogenomics gives providers the chance to fine-tune treatment and enables improved decision-making regarding prescription medications.”

The legislation will also allocate $7M per fiscal year from 2022 until 2025 to fund implementation research on conduct, support and maintenance of pharmacogenomic medicine through the Genomic Community Resources program at the National Institute of Health.

“Pharmacogenomics testing is a quickly evolving field of personalized medicine and this information is critical for the over 40 million Americans taking more than five medications daily,” said Swalwell. “Patients and medical professionals must understand their potential uses to make informed treatment decisions that are best for each individual patient.”

Emmer and Swalwell are co-chairs of the Personalized Medicine Caucus. The bill is supported by the Personalized Medicine Coalition, the American College of Medical Genetics and Genomics, Invitae, the Association for Managed Care Pharmacy, the American Society of Pharmacovigilance, Genomind, OneOme, GenXys, Sanford Imagenetics, and the GTMRx Institute.

Medical genetics company Invitae, are strongly supportive of the bill. According to research carried out by Invitae and the University of Utah, use of pharmacogenetic testing for just four months in elderly patients reduced emergency department visits as a result of adverse drug reactions by 71% and hospitalizations by 39%.

“The introduction of the Right Drug Dose Now Act is an important step toward increasing access to pharmacogenomic testing, and we thank Representatives Swalwell and Emmer for their tireless work to make sure all Americans have access to precision medicine. Congress should act quickly to enact the Right Drug Dose Now Act,” says Kristine Ashcraft, Medical Affairs Director, Pharmacogenomics at Invitae, in a press statement.