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.


Scam Phone Calls Continue; IRS Identifies Five Easy Ways To Spot Suspicious Calls

The Internal Revenue Service issued a consumer alert today providing taxpayers with additional tips to protect themselves from telephone scam artists calling and pretending to be with the IRS.   These callers may demand money or may say you have a refund due and try to trick you into sharing private information. These con artists can sound convincing when they call. They ... (click for more)

CBL & Associates Properties To Pay Common And Preferred Stock Dividends

CBL & Associates Properties, Inc. Thursday announced that its Board of Directors has declared a quarterly cash dividend for the company’s Common Stock of $0.245 per share for the quarter ending Sept. 30. The dividend is payable on Oct. 15 to shareholders of record as of Sept. 30. The Board also declared a quarterly cash dividend of $0.4609375 per depositary share for the ... (click for more)

Bradley, 24, Charged In Death Of Boy, 3; Child Had Numerous Injuries After Left With Boyfriend; Mother Was In Workhouse

Justin Dale Bradley has been charged with criminal homicide in the death of a three-year-old child, who was rushed to the hospital on Wednesday and later died. Police said Dakota James Arndt had numerous injuries over his body. Authorities said Bradley, 24, is the boyfriend of the child's mother, Brianna Kwekel, who was in the Workhouse at the time. Ms. Kwekel was serving 48 ... (click for more)

Helen Burns Sharp Asks Recovery Of Legal Fees In Successful Black Creek TIF Lawsuit

Helen Burns Sharp, citizen activist who sued to try to stop a $9 million Black Creek Tax Increment Financing (TIF) and won, is seeking to have her legal expenses paid by the city and the developers. Ms. Sharp said in a court filing that her legal bills to attorney John Konvalinka are $74,427 thus far. Chancellor Frank Brown ruled in favor of Ms. Sharp, saying the Sunshine ... (click for more)

The Many Lessons I Learned From Helen McDonald Exum

Helen McDonald Exum was my friend and mentor. As I think of her passing I can only imagine the celebration that is happening in heaven as the news of her arrival is being told. I am sure that there is a party that not only has she organized but that there is not a detail that has been left to chance. I am sure that it is the grandest of events, for you see, she has been planing ... (click for more)

Insurance Burden Should Not Fall On The Teachers

I have attended several Hamilton County School Board meetings over the past few months, including the recent special called meeting" to vote on teacher insurance changes. First, let me say I am very impressed with Superintendent Rick Smith and his staff at the Central Office.  Mr. Smith is a very dedicated public servant, working hard to provide services to our community ... (click for more)