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.



Chattanooga Cancer Support Group Leader Attends American Hematology Conference

For the 5th consecutive year, Linda Huguelet, co-leader of the Chattanooga Multiple Myeloma Networking Group, is joining over 25,000 hematologists and healthcare professionals from around the world at the 59th American Society of Hematology Annual Meeting and Exposition.  The meeting is being held in Atlanta Dec. 8-11. Ms. Huguelet was selected by the International Myeloma ... (click for more)

Enroll The Region Helps Public Obtain Health Insurance

Enroll The Region is a grass roots organization of trained volunteers dedicated to helping people enroll and obtain health insurance through the Federal Marketplace.  People obtaining health insurance through the Federal Marketplace may receive help to pay for this insurance based on income, household size, and other factors.  Many qualify for the Silver plan with no monthly ... (click for more)

Clerk Shot During Holdup At Lee Highway Convenience Store Early Saturday Morning

A clerk was shot during a holdup at a convenience store on Lee Highway early Saturday morning. Paul Evans, 24, has non-life threatening injuries. At approximately  12:56 a.m.  Chattanooga Police responded to a person shot call at the Mapco at 6200 Lee Highway.   Upon arrival, Chattanooga Police officers located the victim. He told police that a man armed ... (click for more)

Woman Shot Twice By Estranged Boyfriend In Front Of Multiple People At Her Home In Dalton

A woman's estranged boyfriend entered her residence in Dalton on Friday night and shot her twice in front of a group of people, authorities said. Heather Renee Griffin, 42, was transported to Hamilton Medical Center and later transferred to Erlanger Hospital in Chattanooga. Police are searching for Bertram Gerome Beck in the incident. At 7:35 p.m., the Whitfield County ... (click for more)

Connie McDade Enriched The Lives Of Hundreds Of Students

The message about Connie McDade was very touching. I was one of Connie's professors at UTC and thankfully she excelled anyway.  She was an enthusiastic educator, an exceptional person and generous individual.  She was a devoted teacher, loving wife, wonderful mentor and someone who will continue to bring joy to others beyond this life.   Future students ... (click for more)

Roy Exum: Why Not Good People?

It makes no difference if you are a Republican or Democrat, liberal or conservative – I believe we will all come up short this Tuesday when Alabama announces the winner of a special election for a new Senator. On one hand you have Roy Moore, a controversial judge who has been bounced off the state’s Supreme Court twice, painted as a pedophile by numerous accusers, and just observed ... (click for more)