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.”

Flu Vaccine Clinic Saturday At CHI Memorial Convenient Care - Cleveland

CHI Memorial Convenient Care – Cleveland will host a flu vaccine clinic on Saturday from 9-11 a.m. Regular flu vaccines will be available for ages four and up. Those 65 and older are eligible for the high dose vaccine, which will also be offered at this location.  Most insurance companies will pay 100 percent of the cost.  The vaccine is $25 for those who don’t have ... (click for more)

Life Care Center Of Hixson Helps Woman Walk Again

Sharon Lewis is returning home able to walk after a remarkable recovery at Life Care Center of Hixson, according to officials. Ms. Lewis became ill from streptococcus pneumoniae, and the disease caused her immune system to weaken dramatically. She developed an infection called sepsis, which occurs when chemicals are released into the bloodstream to fight an infection and triggers ... (click for more)

Domestic Assault Charge Dismissed Against Bobby Stone In Case Involving Mayor's Top Advisor; Stone Says Berke Had Inappropriate Relationship With His Wife; Says Berke And Fletcher Conspired To Arrest Him; Lacie Stone Says Charges Completely False

A charge of domestic assault was dismissed Friday morning against Bobby Stone in a case involving a top advisor to Mayor Andy Berke.  Afterward, Mr. Stone told reporters that the mayor had an inappropriate relationship with his wife, Lacie Stone. He also charged that Mayor Berke and Police Chief Fred Fletcher conspired to arrest him. Mr. Stone is expected to file ... (click for more)

Christopher Padgett Taken Into Custody

A Chattanooga man who went on the lam after cutting off his ankle monitor and failing to show up for the third day of his felony murder trial is back in custody. Christopher Padgett was arrested by Chattanooga Police in the 3200 block of South Street at 12:55 a.m.  He was taken into custody without incident and transported to the Hamilton County Jail for booking. ... (click for more)

Bobby Stone, Is It Really A Win?

It brought a smile to my face this morning when I saw where the case was thrown out of court against Mr. Stone and the domestic violence charge.  I have supported his cause from the beginning, but I do feel heartbreak because his personal life had to be tossed out there for all of us to see.   I truly hope and pray things turn around for him and his wife, while I feel ... (click for more)

Roy Exum: Kelly Could Win It

I am neither a sleuth nor an odds maker but I’d say there is about a one-in-three chance that Interim Hamilton County Department of Education Superintendent Kirk Kelly could become the permanent superintendent of our public schools next Thursday. I am assured something squirrelly is happening on our newly-seated school board. It has been seven months since the last superintendent ... (click for more)