Alexander: Senate One Step Closer To Passing Compounding Agreement To Help Prevent Future Tragedies

Wednesday, November 13, 2013

Senator Lamar Alexander (R-Tn.), the senior Republican on the Senate health committee, on Tuesday praised the Senate’s vote, 97 to 1, to move forward on consideration of the legislative agreement he reached with House and Senate health committee leaders to make injections of compounded sterile drugs safer. The House passed the bill on Sept. 28.

Senator Alexander said, “The Senate should consider and pass this legislation immediately so we can help prevent another meningitis outbreak like the one that has killed 16 Tennesseans and made so many others so sick. The FDA commissioner has warned us that it’s a matter of when, not if, this will happen again if we don’t clarify oversight of compounders. Tonight’s vote is an important step toward doing just that.”

Last November, when the Senate Health, Education, Labor and Pensions (HELP) Committee held its first hearing on the deadly meningitis outbreak, Senator Alexander called for a new model of oversight of sterile compounding pharmacies. Today’s bill represents an agreement announced by Senaotr Alexander and HELP Committee Chairman Tom Harkin (D-Ia.), House Energy and Commerce Chairman Fred Upton (R-Mi.) and Ranking Member Henry Waxman (D-Ca.) to clarify current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.

The bill also includes legislation to track and trace the more than 4 billion prescriptions that are written in America every year to help ensure their safety. There is currently no system for tracking prescription drugs, which means consumers can receive drugs that are stolen, counterfeit, or ineffective.  The bill would create a new uniform framework for tracking drugs from the manufacturer to the pharmacy.

The bill is supported by the Tennessee Pharmacists’ Association, who have said: "We believe this compromise proposal offers an effective approach to address complex issues surrounding compounded medications by having the Food and Drug Administration (FDA) focus on entities that are compounding outside the scope of traditional pharmacy compounding while leaving traditional pharmacy compounding under the oversight of state boards of pharmacy."

The legislation distinguishes compounders engaged in traditional pharmacy practice 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 Food and Drug Administration as “outsourcing facilities,” subject to FDA oversight in much the same way as traditional manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.

It also offers providers and patients better information about compounded drugs, by directing FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requiring detailed labeling on compounded drugs, and prohibiting false and misleading advertising.


UNUM Hosts Back To School Bash For Chambliss Children

UNUM hosted its annual Back to School Bash for the school-aged children spending the summer at Chambliss Center for Children.   This year more than 175 UNUM employees came out to host a special day on our campus that included inflatables, games, a petting zoo, snow cones, face painting, hot dogs, burgers and more. They also stuffed 125 backpacks full of the required ... (click for more)

Alexander: FDA Is Exactly Right to Keep Your Fitbit, Weight Watchers App Free Of Government Red Tape

Senate health committee Chairman Lamar Alexander (R-Tenn.) said the Food and Drug Administration (FDA) is “exactly right to keep your Fitbit or Weight Watchers app free of unnecessary government oversight and red tape.” “The recent surge of innovative fitness trackers and mobile health apps is good news for Americans who want to take an active role in monitoring and ... (click for more)

Man, 28, Shot And Killed In East Chattanooga

A 28-year-old man was shot and killed in East Chattanooga early Friday morning. The victim was identified as Jeremy Clark. At 1:20 a.m., Chattanooga Police officers responded to 2008 Glass St. on a person shot. One victim was found suffering from a gunshot wound. He was pronounced dead on the scene. Police said investigators were gathering information on the potential ... (click for more)

Siedlecki Files Amended Financial Disclosure After GOP Files Complaint; Lists Personal Loan Rather Than In-Kind Contribution

Democratic assessor of property candidate Mark Siedlecki filed an amended financial disclosure form on Friday afternoon after county Republicans said he accepted far above the legal limit from a corporation he heads. The new disclosure said he made personal loans totaling $38,288 to the campaign. It does not include any in-kind contributions. The earlier forms listed ... (click for more)

Olympic Events On The Ocoee River Made History – But It Wasn’t Easy

It started with a simple “what if” question while Atlanta officials were working on a bid to host the 1996 Summer Olympic Games.  A group of amateur kayakers from the city began asking themselves: “What if Atlanta’s bid is successful? Then where would the Olympic whitewater canoe and kayak races be held?”  To some of the members of that group, the answer was obvious. ... (click for more)

Roy Exum: Mr. Siedlecki, Sit Down!

This is a personal thing but one of my pet peeves is the little advertising stickers I sometimes find on the top of the front page of my newspaper. An editor at the newspaper has already determined a bit of news he or she feels I should read. And then the sticker covers it up so I have to peel it off before I can read “All the news that is fit to print.” As I groveled over my ... (click for more)