FDA OKs Genetic Tests For Rare Diseases
One company, 23andMe, had discontinued the test in late 2013 after the Food and Drug Administration warned it must be approved before marketing. Elsewhere, scrutiny pinches drug compounding companies and a sunscreen law awaits federal review.
The New York Times:
FDA Eases Access To DNA Tests Of Rare Disorders
The genetic testing company 23andMe on Thursday took a step toward being able to offer consumers health-related information again, winning approval from the Food and Drug Administration for a test for mutations that cause a rare disease. The company, a pioneer in offering genetic tests direct to consumers from a sample of spit, stopped doing health-related testing in late 2013 after the F.D.A., in a scathing warning letter, said that such tests required the agency’s approval before they could be marketed. (Pollack, 2/19)
The Associated Press:
FDA Eases Access To DNA Screening For Inherited Diseases
Federal health officials are easing access to DNA tests used to screen parents for devastating genetic disorders that can be passed on to their children. The surprise announcement offers a path forward for Google-backed genetic testing firm 23andMe, which previously clashed with regulators over its direct-to-consumer technology. (Perrone, 2/19)
The Wall Street Journal's Pharmalot:
Compounding Pharmacies Feel A Squeeze
As far as compounding pharmacies are concerned, the U.S. Food and Drug Administration is compounding their problems. Compounders make drugs prescribed by doctors for specific patients whose needs aren't met by commercially available drugs. But since a meningitis outbreak that claimed 64 lives two years ago was traced to a compounding pharmacy, the agency has cracked down. Dozens of compounders have been inspected, and some were issued warning letters for poor practices. In a few instances, the FDA urged the public to avoid a compounder’s medicines or attempted to shutter an operation. (Silverman, 2/19)
CQ Healthbeat:
FDA Throws Roadblocks In Front Of Sunscreen Law
A new law to speed federal review of sunscreens is causing problems for the Food and Drug Administration, which is insisting on additional tests that could undercut the measure's targets. Skin cancer patient advocates had hoped safer suntan lotions would be available as early as this summer under the law, which allows the FDA to respond to a backlog of over-the-counter sunscreen ingredient applications – some of which have languished at the agency for decades – in an expedited manner. (Zanona, 2/19)
