By Clinical Informatics News Staff 

 

November 26, 2014 | While families the nation over are preparing for Thanksgiving dinner, the FDA has been hard at work protecting us from the scourge of overeating. This week the agency finalized its rules for public calorie counts in chain restaurants, vending machines, and even movie theaters, which have been pending since the passage of the Patient Protection and Affordable Care Act in 2010. The whole country will soon be following the lead of New York City, where calorie counts are prominently displayed on menus and signage, in the hopes of encouraging Americans to pay better attention to their diets.

 

But it’s the “drug” half of the Food and Drug Administration that has really been reexamining its role in a changing industry this year, reevaluating both how it reviews new kinds of biotech diagnostics, and where it fits in a healthcare system that has increasingly probed the limits of FDA oversight. So while we’re out of the office for the holiday, kick back and digest some of the big stories to come out of the FDA this year.

 

FDA Moves on Lab Developed Tests: For labs and hospitals across the country, the FDA’s most dramatic action of 2014 has been its decision to regulate laboratory developed tests the same way it does other diagnostics. As the agency closes this 30-year-old loophole, Clinical Informatics News digs into the implications — both for the big commercial labs who have bracing for new responsibilities, and the academic labs who are nervous they’ll fall through the cracks.

 

Inside the HIVE, the FDA’s Multi-Omics Compute Architecture: The clinical trial data of the future will be orders of magnitude larger than in the past, as genomic and proteomic technologies become ingrained in co-diagnostics and patient stratification.

 

At Next Generation Dx Summit, FDA Discusses Approval of NGS Assays: It’s been just about a year since the FDA cleared the first next generation sequencing tests for clinical use, making one of the 21st century’s most powerful scientific breakthroughs more widely available to physicians and patients. FDA representatives share how the agency rethought its review process to accommodate these tricky-to-evaluate technologies.

 

FDA Releases Social Media Draft Guidances: The advertising practices of pharmaceutical and medical device companies have always been a vexed subject, and the explosion of new web marketing tools has only made the questions thornier.

 

OpenFDA to Encourage Public Scrutiny of Health Data: A pilot project is crowdsourcing ideas to use the reams of health data collected by the FDA to serve our national care system.

 

FDA Grants Breakthrough Status to Gene Therapy for First Time: Gene therapies have struggled to overcome the stigma of deadly incidents in the late 1990’s, but breakthroughs in safe administration are warming the FDA to newer drug candidates. (To see what this looks like from industry’s point of view, see our profile of Spark Therapeutics.)

 

23andMe Suspends Sale of Health Tests: The FDA has made more impactful decisions this year, but nothing stirred up as much drama as its crackdown on genetic testing company 23andMe’s direct-to-consumer health reports. After years of uncertainty, last November saw a firm stance from the agency: genetic health tests are medical devices and will be regulated as such.