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.”


Morning Pointe Senior Living Donates $3,000 To Partnership Food Pantry

Partnership for Families, Children and Adults is appreciative to be the recipient of a $3,000 donation from Morning Pointe Senior Living to continue the work of an elder food pantry.    The pantry is accessible to seniors and disabled individuals who are either working with Partnership FCA case managers or enrolled in the Homemakers program. In the three years ... (click for more)

Stewart To Serve As 2017 Great Strides’ Community Chair

Cleveland business leader Lee Stewart will serve as community chair for Great Strides 2017, according to campaign officials at Lee University. The 17th annual Great Strides Walk and 15th annual 65 Roses 5K, which raises funds and awareness for the Cystic Fibrosis Foundation, will be held on Saturday, April 1.  “It will be a pleasure to serve with Lee Stewart, who has agreed ... (click for more)

2 Homes Totally Destroyed By Fire On Sunday In Separate Blazes

Two homes were totally destroyed by fire in separate blazes on Sunday afternoon. At  5 p.m. , a neighbor called 911 reporting a house fire at 3910 Fairmont Pike on Signal Mountain. Walden's Ridge Emergency Services responded and arrived on the scene reporting a fully involved house fire. A mutual aid response was requested for additional manpower and apparatus ... (click for more)

Signal School Study Says Under Own School System Much More Could Go To The Classroom; Lennon Says Getting Land, Buildings A Major Issue

A panel studying a new school system operated by Signal Mountain concluded that much more money could go directly into the classroom, helping students further increase their potential.   However, County School Board member Kathy Lennon said how the town would be able to acquire the land and buildings is a major issue.   A group of Signal Mountain residents ... (click for more)

CVB Should Share Financials With The Home Folks

The recent debate over the Convention and Visitor's Bureau's funding and budget has gotten ugly. A Hamilton County commissioner has asked questions and made comments about the CVB. The director of the CVB has organized a campaign to dismiss the commissioner's questions and comments. The children on the playground are choosing sides and nothing useful seems to be happening. It's ... (click for more)

Roy Exum: Trump's Latest Delight

I was quite amused this week when Donald Trump’s administration “locked out” several news organizations from the daily press briefings at the White House. The reason I loved it because in the 50 years I have spent in the news business, I have been locked out of press conferences, too. To be truthful, I am a longtime veteran of a bunch of “you versus me” squabbles and, if I do say, ... (click for more)