Alexander: Congress Must Hold FDA Accountable

Friday, January 03, 2014

U.S. Senator Lamar Alexander, the lead Republican on the Senate health committee, Friday said that he’ll push in 2014 for an oversight hearing of the Food and Drug Administration and monitor its activities to ensure proper implementation of his legislation to help prevent another meningitis outbreak in Tennessee, which became law on Nov. 27.

“We worked for a year to create legislation that would help prevent another meningitis outbreak like the one that killed 16 Tennesseans and made so many others sick,” Senator Alexander said. “Tennesseans deserve to know that the FDA and other regulators are properly implementing this new law, which makes clear who is on the flagpole to prevent another nightmare like the deadly meningitis outbreak of 2012.”

The Drug Quality and Security Act distinguishes between compounders engaged in the traditional pharmacy practice of making customized drugs for specific patient needs from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register with the FDA as “outsourcing facilities” and become subject to federal oversight like traditional drug manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy. 

The legislation is based on a proposal Senator Alexander introduced in the U.S. Senate, as well as an agreement he helped reach with the U.S. House of Representatives. It also includes provisions to track and trace the more than 4 billion prescriptions that are written every year to help ensure their safety, and provides patients with better information on compounded drugs, said officials.

In November of 2012, when the Senate Health, Education, Labor and Pensions Committee held its first hearing on the deadly meningitis outbreak, Senator Alexander called for a new model of oversight of sterile compounding pharmacies. Alexander and HELP Committee Chairman Tom Harkin (D-Iowa), House Energy and Commerce Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.) announced a legislative agreement and the bill was passed by the House on Sept. 28. The Drug Quality and Security Act cleared by both houses of Congress on Nov. 18, and the president signed it Nov. 27.


Morning Pointe Hosts Car Wash And Hot Dog Sale This Saturday

Morning Pointe of Chattanooga will be having a car wash and hot dog sale this Saturday from 8 a.m. – noon at the assisted living facility. All proceeds will go to the Alzheimer’s Association.   (click for more)

Gregory J. Nieckula, D.O. Joins Signal Mountain Health And Wellness

Memorial Health Partners Foundation announces Gregory J. Nieckula, D.O. has joined Signal Mountain Health & Wellness. Dr. Nieckula is a graduate of Lincoln Memorial University DeBusk College of Osteopathic Medicine, Harrogate, Tn. He completed his residency at University of Tennessee College of Medicine, Chattanooga. "We are pleased to welcome Dr. Nieckula aboard the Signal ... (click for more)

EPB Files With FCC To Expand TV, Phone, Internet Offerings Outside Electric Service Area

 EPB announced Thursday that it has filed a petition to the FCC "in an effort to respond to neighboring communities’ requests for access to the company’s gigabit enabled high-speed Internet service." Officials said, "EPB offers high-speed Internet access, video programming and voice services using a fiber optic communications network that allows the company to deliver these ... (click for more)

Black Creek Developers Say They "Followed The Rules" On $9 Million TIF: To Continue Project

The developers of the Black Creek project at Aetna Mountain said Thursday they "complied precisely by the rules when we applied for and received approval of the TIF district." Doug Stein said the group plans to continue on with the project, which he said earlier would include the creation of a small town on a huge undeveloped tract on the mountain above Black Creek (formerly ... (click for more)

Pickle Ball? - And Response

Collegedale has done some wonderful things for its residents.  The Greenway is a perfect example of money well spent on helping to give her residents the opportunity to improve their lives, at least from a health standpoint. Having taught at Wolftever Creek for a decade plus, I was fortunate to have opportunity to take my classes on walks from time to time.  It provided ... (click for more)

Roy Exum: The NCAA’s “Division IV”

Jonathan Jensen and Brian Turner are two very smart guys. Not long ago the two sports researchers at Ohio State authored a story that appeared in the Journal of Quantitative Analysis in Sports that focused on the most successful college football teams in the country and, earlier this week, a writer named Ben Cohen broke it down in understandable terms for a fascinating Wall Street ... (click for more)