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.


$7 Million Prevention Effort To Target 12-25-Year-Olds In East Tennessee

The Tennessee Department of Mental Health and Substance Abuse Services is teaming up with community anti-drug coalitions across a 10-county region of East Tennessee in an effort to reduce the number of young people who are abusing prescription drugs. To help achieve this goal, TDMHSAS has secured nearly $7 million dollars in federal grant funds to engage with young people through ... (click for more)

Christmas In The Cove Is Dec. 4

Christmas in the Cove will be Dec. 4, from 6-8 p.m., with a tree lighting at 6 p.m. The event will be at Garden Plaza of Greenbriar Cove, 4586 Forsythia Way, Ooltewah, Tn. 37363.   • Come see Elsa and Anna, along with all the other characters from Disney’s movie Frozen. • Have your picture taken with Santa. • Listen to music by the Southern Adventist University ... (click for more)

Grote Hall At UTC Campus Closed Due To Sinkhole

A sinkhole has prompted UTC officials to close off access to Grote Hall. Grote Hall employees have been told they do not need to report to work on Monday. Classes that are held in Grote Hall are called off for Monday. All other classes and campus activities are on for Monday. (click for more)

Bradley County Police Investigating Shooting; Victim Dies

The Bradley County Sheriff’s Office is investigating a shooting that occurred in the area of Georgetown Road. The sheriff's office said Sunday night that the victim had died. The victim's name has not yet been released.  A BCSO officer was waved down at the intersection of 25 th Street and Peerless Road by the driver of a vehicle who told the officer a gunshot victim ... (click for more)

Don't Be Quick To Discard Common Core

Let's not be too quick to discard Common Core. A recent article in the Tennessean on  Sunday detailed Common Core successes the Kingsport, Tennessee school system.  I encourage you to read it.  The article also noted that Tennessee was recently ranked as one of the fastest improving states in education after implementing portions of the Common Core curriculum ... (click for more)

Roy Exum: Our Tubman Goat-Roping

Every spring there comes a bright day on the ranch when the straw-boss decrees a goat-roping should take place. What really happens is the veteran cowboys arm the greenhorns with some lariats late in the afternoon and take them to the pen that holds some Billy goats. This is before they get into bigger beasts -- horses and cattle – yet what appears to be easy most certainly is not. ... (click for more)