FDA approved record number of personalized medicines in 2018: report

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The FDA approved a record number of personalized medical treatments in 2018. (FDA)

More than 1 out of every 3 therapies approved by the Food and Drug Administration in the past two years includes information on the label identifying patients who are most likely to realize the benefits—or experience fewer side effects—from the treatment.

In a report released by the Personalized Medical Coalition (PMC) following the organization’s annual conference in November, data suggests that U.S. policymakers could address rising healthcare costs by personalizing medical treatments.

The Personalized Medicine at FDA: A Progress & Outlook Report (PDF) gives credit to the FDA for accelerating the trend of patients and payers embracing personalized medicine. In fact, personalized medicines have made up 20% of FDA approvals over the last five years, with that number jumping to 40% in 2018. Specifically, 25 of the 59 new molecular entities that the FDA approved in 2018 were personalized medicines. 


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​​​​​"Last year was a banner year for personalized medicine, as evidenced by the record number of FDA approvals of new drugs with biomarker strategies referenced in their labels, but we cannot take that progress for granted," PMC President Edward Abrahams told FierceHealthcare.

The FDA is also responsible for pushing forward digital health initiatives that help to encourage the use of personalized medicine by matching new personalized medicine products with the patients who are most likely to benefit or have the least amount of side effects. 

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Still, cost is a large factor in the process of initial diagnostic testing that can lead to personalized treatments. And policies—such as the recent push from the current administration onto Medicare Advantage to try less expensive treatments first—discourage gains in personalized therapies. 

"Driving treatment decisions by cost considerations rather than determining what treatment would work best for an individual patient fundamentally conflicts with personalized medicine, and in many cases will increase downstream costs brought on by continued progression of disease and more adverse side effects," the report noted.

Other gains noted in 2018 include the first public database to support regulatory oversight of variant/disease claims and the marketing of the first direct-to-consumer genetic test for cancer risk.

In order to continue moving forward with personalized medical innovation, Abrahams places the burden on Congress, Centers for Medicare & Medicaid Services (CMS) and FDA to carve out policies that recognize the successes of individualized care. 

“These developments continue to pose challenges related to scientific discovery, diagnostic regulatory policy, investment incentives, coverage and reimbursement, and the implementation of new technologies into clinical practice,” the report concluded. “But the science, more than ever, is leading the health system away from one-size-fits-all, trial-and-error medicine and toward the utilization of molecular information to improve outcomes and make the health system more efficient.”

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