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.


Clancy J. Covert Is Nominated And Accepted As A 2016 AIOCLA’S 10 Best In Tennessee For Client Satisfaction

The American Institute of Criminal Law Attorneys has recognized the performance of Tennessee’s Criminal Law Attorney Clancy J. Covert as 2016 10 Best Criminal Law Attorneys for Client Satisfaction. The American Institute of Criminal Law Attorneys is a third-party attorney rating organization that publishes an annual list of the Top 10 Criminal Law attorneys in each state. ... (click for more)

LBMC Names Riddle Partner In Information Security Division

LBMC Information Security, a division of LBMC, announces the naming of Jason Riddle as partner. "Mr. Riddle, CISSP, is an information systems security expert with broad technology expertise and experience with a variety of industries including healthcare, financial services, and retail. Jason has over fifteen years’ experience in the information technology and security ... (click for more)

Strong Thunderstorm Causes Damage, Power Outages In Dalton

Shortly before  5 p.m. , a strong thunderstorm went through downtown Dalton, knocking down numerous trees, causing power outages and also causing damage. At this time, no injuries have been reported.  The Dalton Fire Department and Dalton Police Department responded to multiple reports of damage. The DPD closed several roads due to downed trees and power lines. ... (click for more)

Chattanooga Honors Military Veterans

A Memorial Day service was held at the National Cemetery on Monday. (click for more)

Parking Discrimination Downtown

Many taxpayers who reside in Chattanooga (but outside Chattanooga's core) feel left behind when it comes to neighborhood paving, sidewalks, policing, streetscaping, street sweeping, public transportation, and other services. Some think most tax dollars are spent on downtown and not in their neighborhoods. It's not as if they can't vicariously experience the largesse of downtown. ... (click for more)

Don't Squander The 2016 Election Opportunity

This is what I don't understand. Christians refusing to vote for anyone who is not squeaky clean and who doesn't live up to our standards. I'm not bashing Christians. I proudly proclaim Jesus as Lord and Savior.  But If we made our voice known more we could have a lot greater influence than we have. And I don't mean just boycotting. I specifically mean the last two ... (click for more)