Gerald Yorioka, MD, SCMS President
The FDA is planning to release guidelines to facilitate the approval of drugs targeting cancer-linked DNA mutations. The current process of FDA approval is costly and time-consuming, and disheartening to patients with a current diagnosis of cancer. The new proposal is titled Medical Innovation Development Plan and is in response to a February Presidential speech before Congress. Most applications for the introduction of new drugs requires over 200,000 patients who would be affected. Below that cutoff level, the applications would be categorized as “orphan drugs.” The new policy is to expect an FDA response within 90 days.
The King County Medical Society offered a CME program “Are You Ready for Genomic Diagnostics?” open to Snohomish County Medical Society members on June 18. The program was focused on diagnostic capabilities, but the ultimate goal would be to achieve therapeutic benefits.
We may be on the threshold of a new practice of medicine for the 21st Century, so this proposed move by the FDA may be welcome news that will save lives in previously hopeless situations. In line with this a subsequent Newsmax article “Personalized Vaccines Hold Cancer at Bay” July 5, presents this to the public as “Novel class of personalized cancer vaccines.”