Alexander: Congress Must Hold FDA Accountable

Friday, January 3, 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.



Children’s Hospital At Erlanger Outpatient Center Wins National Design Award

Children’s Hospital at Erlanger Outpatient Center has been recognized with an American Institute of Architects Richmond Honor Award of Excellence in Architecture.  The AIA Richmond Honor Award recognizes works that exemplify excellence in architecture, interior architecture and urban design.   “In addition to creating an inspiring, playful and wonderful healing ... (click for more)

State Human Services Applauds Passage Of Welfare System Update

The Tennessee Department of Human Services (TDHS) is applauding the passage of key changes to the State’s Families First program.   These changes help ensure families receiving Temporary Assistance for Needy Families (TANF) benefits administered through Families First have the necessary assistance they need to meet today’s economic realities, it was stated.   ... (click for more)

Chattanooga Police Arrest Robbery Suspects Within Hours Of Holdup; Citizen Takes Quick Photo Of Suspect Vehicle

Chattanooga Police officers arrested two suspects involved in an armed robbery within hours of the incident. Officers responded to an armed robbery call at 5966 Brainerd Road  at 1 p.m. on Wednesday. The victim told police she was exiting her vehicle when she was approached by a white male pointing a handgun at her demanding her purse and cell phone. The victim ... (click for more)

WACKER-Charleston Taking Initial Steps To Restart Polysilicon Production After Explosion Shut Facility Last September

WACKER-Charleston announced Thursday it has resumed operations for the production of polysilicon. Using a phase-in approach, WACKER has begun the initial start-up of the site, beginning with distillation. The initial production of polysilicon is targeted to begin in the next few weeks. WACKER anticipates the Charleston site will reach full capacity in the fourth quarter ... (click for more)

Keep The Gifted Program In The Hamilton County Schools - And Response (2)

I currently have a daughter in fourth grade at Lookout Valley Elementary and a daughter in the eighth grade at Lookout Valley Middle High School. Both of my daughters are very good students, as well as being very good people. I am writing today with a concern. I was made aware that the Hamilton County Department of Education is considering cutting the gifted program ... (click for more)

Roy Exum: Remarkable Diane Black

As I was introduced to Tennessee gubernatorial candidate Diane Black on Thursday afternoon, I told her that one of my favorite stories is about her when she was a young, single mother in Baltimore. Her nursing job required her to sign on no later than 6:30 a.m. for work in the emergency room each day but … she had to bathe, dress, and feed her three infants and get each to a different ... (click for more)