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.


New Hamilton County Businesses

Here are the new business licenses from the County Clerk's office: 110% AUTHENTIC 1900 S HOLTZCLAW AVE CHATTANOOGA, TN 37404 3D OPERATIONS INC 340 FRAZIER AVE CHATTANOOGA, TN 37405 4 CORNERS CAFE LLC 9408 APISON PIKE SUITE 102 OOLTEWAH, TN 37363 ACE EXTERMINATING COMPANY INC 5113 HWY 58 STORE A-3 CHATTANOOGA, TN 37416 ADONAI PAINTING VARIOUS ... (click for more)

Partnership FCA Announces Thrift Store Grand Opening

Partnership for Families, Children and Adults announced the Grand Opening of a retail store, Partnership FCA Thrift and Consignment. The store opens  Aug. 30  and is located at 301-D Martin Luther King Boulevard. The grand opening will be celebrated with a ribbon cutting and reception at  11 a.m.  on  Tuesday, Aug. 30 . Regular business hours will ... (click for more)

TBI Adds Jereme Little To Top 10 Most Wanted; Was Set Free By Judge Stern And Then Higher Court Overruled Her

The Tennessee Bureau of Investigation has added to its ‘Top 10 Most Wanted’ list Jereme Dannuel Little, who was freed by order of Criminal Court Judge Rebecca Stern, whose decision was recently reversed. Little is wanted by the Chattanooga Police Department and the Tennessee Bureau of Investigation for especially aggravated kidnapping. The TBI said, "Little has a history of ... (click for more)

Gaines Charged In Assault On Ex-Wife, MLK Boulevard Barber

Eric Lee Gaines has been arrested for an assault on his ex-wife and a well-known MLK Boulevard barber. Gaines, 33, of 2803 Curtis St., was charged with disorderly conduct, domestic assault, assault, burglary of a business, public intoxication and retaliation against an officer. In the incident on Thursday, police were summoned to MLK Boulevard on an intoxicated individual. ... (click for more)

Jonathan Welch Is To Be Commended For His Leadership On The School Board

Dr. Jonathan Welch has faithfully served the Hamilton County Board of Education, representing District 2, for the last four years. He ends his time on the school board as chairman, a role he stewarded well during a tumultuous time in our school system as we prepared to search for a new superintendent.  Jonathan has served our school system and represented ... (click for more)

Roy Exum: Georgia’s Weak Attacked

The United States Attorney’s Office and our nation’s Justice Department just thrust an unwelcomed spear into the heart of the state of Georgia. And while I am scared to death the same war party is now headed into Tennessee and other states, I wish the DOJ had stopped in Chattanooga for lunch and a quick visit at our Orange Grove Center before filing last Tuesday’s lawsuit against ... (click for more)