Alexander Says Congress Must Act Soon To Prevent Another Health Crisis

After Recall Of Tainted Drug In Texas

Monday, August 12, 2013

The senior Republican on the U.S. Senate health policy committee said Monday that a recall of tainted drugs by a Texas-based compounding facility confirms that “Congress must act soon to prevent another health crisis.” Senator Lamar Alexander has urged the Senate to vote “as soon as possible” on legislation to clarify oversight of businesses that compound drugs, after a deadly meningitis outbreak last year that has led to 15 deaths in Tennessee.

The Food and Drug Administration reports that 15 patients in two hospitals who received compounded drugs from the Texas compounder have developed bacterial bloodstream infections thought to be related to the drug infusions. 

Senator Alexander said Monday: “It is deeply troubling to hear of more patients who may have been harmed by tainted compounding drugs. Senators on the health committee have worked carefully to put together the best possible legislation, because we knew that the lack of accountability over compounding businesses would lead to another crisis like last year’s meningitis outbreak. We know the problem, we have the solution, and it’s up to Congress to pass this bill as soon as it returns.”

Senator Alexander, with committee chairman Tom Harkin (D-Iowa) and Sens. Pat Roberts (R-Kan.) and Al Franken (D-Minn.), introduced the Pharmaceutical Quality, Security, and Accountability Act to help prevent another compounding crisis like the 2012 fungal meningitis outbreak that has led to 63 deaths and 749 illnesses.

The bill, which was passed unanimously by the Senate Health, Education, Labor and Pensions Committee, makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the U.S. Food and Drug Administration. 

A recently released report from the nonpartisan Government Accountability Office confirmed that legislation is needed to clarify the U.S. Food and Drug Administration’s oversight of large-scale drug compounders. The report authors concluded that there are “gaps in oversight” and that “it is essential to have clear roles for FDA and states in regulation and oversight of drug compounding.”

Senator Alexander said about the report: “This nonpartisan compounding report recommends that Congress work on ‘clarifying FDA’s authority,’ and that’s exactly what we’ve done with our legislation.  We’ve worked to put one agency clearly on the flagpole and in charge for each area of compounding or drug manufacturing, so that we don’t have another deadly outbreak for the same reason we did last year. I hope that this report will further encourage my colleagues to support and pass the bill as soon as possible.”


Alcatraz Fitness Celebrates Grand Opening

Alcatraz Fitness announced the grand opening of their new facility located at the Cleveland/Bradley Innovation Center, 3575 Adkisson Dr., Suite 1040, Cleveland, Tn. A grand opening and ribbon cutting celebration has been scheduled for Thursday, Oct. 2.  Open house will begin at 12:30 p.m., with the official ribbon cutting taking place at 1:30 p.m.  The Cleveland/Bradley ... (click for more)

Debra Chew: A Prisoner To Allergies No More

I absolutely could not believe it!   Here we were, new to Tennessee and invited to our first social event.   The house was beautiful, full of our newly made friends – and here I was sneezing uncontrollably…eyes watering…and breathing troubled.   We quickly finished the meal, made our apologies and left.   The culprit: a very large hairy dog. Two weeks ... (click for more)

Sewell Says City, EPB "Close" On Amount Owed By Utility To City On Street Light Overbilling

City Internal Auditor Stan Sewell told City Council members on Tuesday that EPB and the city are "close" on the amount owed by the utility to the city on street light overbilling. Mr. Sewell said the city computed the amount at about $1.2 million, while he said EPB's auditing firm, Mauldin and Jenkins, has it at $1.5 million for an 89-month period that was audited. Mr. Sewell ... (click for more)

City Council Votes 5-4 On New Process For Naming IDB Members

The City Council voted Tuesday night 5-4 to set up a new process for naming members to the Industrial Development Board (IDB), which currently has four vacancies. The process includes three City Council panels: A (Districts 1, 2, 3), B (Districts 4, 5, 6), and C (Districts 7, 8, 9). Group A will fill two of the vacancies and Groups B and C one each. Agreement ... (click for more)

Why So Much For A Rail Study?

From the things that make you go hmm department. Ok, so the feds are giving us $400k and the city is kicking in another $300k for a total of $700k to do a study on having in town rail service. Why so much for a study? Don't get me wrong, I'm totally down with Chattanooga having some passenger trains running around. I get that. It's awesome. We've needed it for a long time. I ... (click for more)

Roy Exum: I’m Certainly No Expert

Sometime on Monday night, after I had written a piece on getting swatted with a switch as a kid, I got an email from ESPN Canada asking if I would be a televised guest on “Off the Record,” the most watched daily sports show in Canada. The subject: corporal punishment in America. Are you kidding me? I am hardly an expert. All weekend my world of sports and its excitement was warped ... (click for more)