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.”

World AIDS Day Events Held Dec. 1 And 6

The Southeast TN Council for HIV/AIDS Care and Prevention, in partnership with the city of Chattanooga and The Hunter Museum of American Art, will host World AIDS Day 2015 events on Tuesday, Dec. 1, and Sunday, Dec. 6. These events will highlight the arc of the pandemic, how the southern United States is the epicenter of the domestic HIV/AIDS epidemic, the ... (click for more)

Free Metabolic Seminars Hosted By CHI Memorial Metabolic And Bariatric Care

Jack F. Rutledge, M.D. and CHI Memorial Metabolic and Bariatric Care will host two free seminars in December on surgical weight loss options. The first seminar will be held at CHI Memorial Hospital in the community room Tuesday, Dec. 1 at 6 p.m. The second seminar will be at the North River Civic Center in Hixson on Tuesday, Dec. 15 at 6 p.m. "Obesity can be devastating to ... (click for more)

Volkswagen Stockholder Files Suit Against Automaker At Chattanooga; Seeks Class Action Status

A Volkswagen stockholder has filed suit in Federal Court in Chattanooga against the automaker, charging that its stock was over-valued and that it has not plummeted due to revelations about emissions cheating. The suit was filed in behalf of Michael Wolfenbarger by Knoxville attorney Gordon Ball and Nashville attorney James Stranch III. It seeks class action status for those ... (click for more)

Woman In Critical Condition After Being Shot In The Face Saturday Night Near O'Rear Street

A woman is in critical condition after she was shot while driving in Chattanooga on Saturday night. Just after  9 p.m. , the Chattanooga Police Department responded to reports of a person shot. Once on the scene, police located a female victim near the 2500 block of O'Rear Street suffering from a life-threatening gunshot wound to the face. The victim was driving a ... (click for more)

Misconceptions About Ban The Box

Mr. Exum,  I want to invite you as a guest speaker at the NAACP General Membership meeting.  I believe we can accomplish our goals and clear up any misconceptions about Ban The Box and the role of the NAACP in a much more meaningful manner face to face.   In that vein I would like to invite you to have coffee with me at Panera Bread.  I will not make a ... (click for more)

Roy Exum: The Trouble With Chicago

On “Black Friday” night, I saw television footage of what was said to be about 2,000 people marching in protest in Chicago. The very vocal mob descended on the toniest street – Michigan Avenue – to spew its rage over a police officer who shot and killed a 17-year-old, this over a year ago in October of 2014. The just-released tapes of the incident embroiled the blacks who insist ... (click for more)