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.


Shriner Luncheon To Honor Morning Pointe Resident

Morning Pointe of Collegedale at Greenbriar Cove hosted a Shriner's luncheon to honor resident Rayford McLaurin.  Mr. McLaurin has dedicated well over 50 years of service as a Shriner for the Alhambra Shrine on East Brainerd Road. He was presented with an Outstanding Service Award by the Shriner's International Chattanooga Oasis of Tennessee.  He has served in ... (click for more)

Erlanger Offers Classes And Events For Aug. 4-10

Erlanger now offers online childbirth education class.  The online class is an easy-to-understand interactive program that includes more than 70 videos, animated illustrations, downloadable PDF files, review quizzes and information specific to Erlanger East and Erlanger Baroness birthing services.  By choosing the online childbirth program, participants will have access ... (click for more)

Harr Outlines $40 Million Plan For Chattanooga Light Rail System

Outgoing Chamber of Commerce President Ron Harr on Monday outlined a $40 million plan for a Chattanooga light rail system that would serve not only downtown, but also the Airport and the Enterprise South Industrial Park. In a speech to the Chattanooga Engineers Club, Mr. Harr said most cities looking at such an ambitious plan "would be facing costs of over a billion dollars." ... (click for more)

Chattanooga Choo Choo Adding Clubs, Restaurants In $7 Million Renovation

The historic Chattanooga Choo Choo is adding clubs and restaurants in a $7 million renovation, it was announced in front of the South Market Street landmark on Monday morning. The Comedy Catch will be moving from its longtime home in Brainerd and there will be a new 500-person music venue that will be in addition to Track 29. The new venue, managed by Track 29, will feature a ... (click for more)

Senator Bob Corker: An Open Letter To Tennesseans

We are incredibly fortunate to live in a state in which companies worldwide are clamoring to establish a presence. Many attribute it to our pro-business culture, well-prepared workforce, low tax environment, right-to-work policies, and engaged citizenry.  That is why the announcement by Volkswagen to build its midsize sports utility vehicle and establish the South’s ... (click for more)

Roy Exum: ‘Our’ American Minute

William J. Federer is one of the leading historians in the United States and every morning I am among thousands of people who get an entertaining email from him called the “American Minute.” I adore it because Bill takes a significant event in American history that happened long ago – but he remembers on the very anniversary of when it occurred. A great example is that last Thursday ... (click for more)