FDA and NIH Working Together To Provide Regulatory Paths for Drugs and Diagnostics

The FDA is working to determine scientific standard relating to the genetic information needs to be provided in order to get approval and ensure they work. Ten percent of the drugs approved have this information included already. The NIH is creating a registry of what is available on the market today and will be able to identify those approved by the FDA, such as tests done by a lab when prescribed by a physician. Recently in the news the FDA called the retail sales of sequencing for selected DNA genes “a medical device” and asked for submission for further evaluation.

FDA States Genetic Tests Are Considered a Medical Device And Thus Need FDA Approval

This is probably a good area for the FDA to step in on all of this as the marketing of sequencing was beginning to take over as far as the focus and perhaps with the NIH and FDA working as a team, it can be kept scientific and will help in further developing of personalized medicine and not be seen as a retail genetic benefit manager.

FDA Ruling with Genetic Testing Puts A Big Hold on the “Genetic Benefit Management Cash Cow” For Retail Stores Marketing to Consumers

In the 3 years of doing the blog even I sometimes really have to look hard to figure out at times what is medical advice and what part of it constitutes marketing for profit and I don’t always get it right either as there’s a lot to look at today, but the fashion of profitability with the retail end of it was perhaps stepping over the line a little bit and this way the FDA will have full information from those who want to continue and basically maybe even add some of this information into the voluntary data base they are speaking of. BD

In a commentary released online by the New England Journal of Medicine, Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration, and Dr. Francis Collins, head of the National Institutes of Health, said their agencies will invest in efforts to provide companies with a clear regulatory path for both drugs and companion diagnostics.

"The success of personalized medicine depends on having accurate diagnostic tests that identify patients who can benefit from targeted therapies," Collins and Hamburg wrote.

To ease the transition from academic discoveries of new genes to potential new drugs, the NIH will develop centers where researchers can screen chemicals to find potential drug candidates, and foster public-private partnerships to move more drug candidates into commercial development.

To address this, NIH will create a voluntary genetic-testing registry on the more than 2,000 genetic tests on the market, offering ready information about whether the tests were cleared by the FDA.