Earlier this week the Personalized Medicine Coalition (PMC) released “Pathways for Oversight of Diagnostics,” a discussion of regulation surrounding personalized medications. Spectrum is a proud member of PMC, a thriving association focused on spreading awareness of personalized medicine.
How is medicine personal?
Personalized medicine is exactly what it sounds like: treatments and medications that are designed specifically for each individual patient. Personalized medicine exists in all health care arenas. When a patient gets diagnosed with cancer, a treatment plan must be created. Does chemotherapy work better or should the patient undergo surgery? Maybe a combination of both? In physical therapy offices, patients are prescribed a tailored exercise regime. Doctors personalize medicine every day when they prescribe unique dosages of a medication to sick patients. For example, a 250-pound man may need a stronger prescription dosage than a 10 year old boy.
Can we regulate personal medicine?
Federal agencies and organizations are definitely trying! The Food and Drug Association (FDA) and Center for Medicare and Medicaid Services (CMS) are the two major players when it comes to regulating personal medication. In many ways, personal medicine is not much different than any other form of treatment; however, regulating and testing personal medicine is a bit more challenging. Like most new treatments, personalized medicine is first put through laboratory development tests. But these tests have been difficult to regulate because people respond to medications and treatments differently. As science continues to develop and medical treatments become more individualized, we are likely to face even bigger challenges when it comes to laws and guidelines.
Which treatments or procedures do you hope become more individualized in the next few years?