Senate Health Committee Passes Alexander And Colleagues’ Bill To Fix Responsibility For Safety Of Sterile Compounded Drugs

Wednesday, May 22, 2013

The Senate Health, Education, Labor and Pensions Committee on Wednesday passed legislation introduced by Ranking Member Lamar Alexander (R-Tn.) and his colleagues to fix responsibility for the safety of sterile compounded drugs and, Alexander said, “avoid another outbreak like the meningitis nightmare that killed 15 Tennesseans and made more than 150 people in our state sick.” The next step is consideration by the full Senate.

Senator Alexander said, “This bill is an important step forward for fixing responsibility for safety of sterile compounded drugs. The bottom line is that, under this legislation, when you walk into a facility that makes drugs, you will now know who is regulating that facility. There will be no confusion about who is in charge of keeping that product safe.

“I do not intend to sit through another hearing where FDA can point its finger at someone else instead of taking responsibility for its failure to regulate and enforce large-scale compounding, or claim it didn’t have clear enough authority.”

The Pharmaceutical Compounding Quality and Accountability Act establishes three categories for the businesses that make compounded drugs. The first category, traditional pharmacies, will continue to be regulated by states. The second category, drug manufacturers, will continue to be regulated by the FDA. The legislation creates a new category for large-scale drug compounders and calls these businesses “compounding manufacturers.” These businesses make sterile compounded drugs in advance of a prescription and sell them across state lines.

Senator Alexander said, “The New England Compounding Center (NECC) would have fallen into this category. The legislation puts the Food and Drug Administration solely in charge and on the flagpole for overseeing these ‘compounding manufacturers.’

“Under our bill, compounding manufacturers will be regulated by the FDA, and, for example, they are subject to regular FDA inspections. NECC was not inspected between 2006 and 2011 by the state or the FDA. Under our bill, compounding pharmacies must report the products made at that facility to the FDA. NECC was making copies of commercially available drugs, which is illegal. Under our bill, they must report to the FDA when things go wrong with a product. Currently, large scale compounders are not required to report to the FDA if they know about a problem with a product. And finally, they must label their products, so patients and doctors know it is compounded, rather than FDA-approved.”

Also at Wednesday’s committee markup, the committee passed the Drug Supply Chain Security Act, a bill to create a new system for tracking drugs from the manufacturer to the pharmacy. This bill will be joined with the compounding legislation in one bill.

Senator Alexander said of the drug tracing legislation, “I’d like to emphasize what a big step this is. We have about four billion prescriptions per year in the United States, and this legislation would create a tracking system for those four billion prescriptions made by over 88 manufacturers on over 3,600 manufacturing lines, which are distributed to patients in a variety of ways, including by 60,000 pharmacies or drug stores.

“This will over several years create a system where we can track each of those prescriptions and make sure that they are what they are supposed to be—that they’re not counterfeit, that they’re not stolen, and that they actually work. It was a big undertaking to write the bill, and it will be an even more important undertaking to assure the safety and the accuracy of these four billion prescriptions.”

In the last year alone there have been three cases of counterfeit Avastin, a cancer drug, being distributed in the U.S. to physicians and patients, when the counterfeit did not contain any of the active ingredient.

The United States has seen an increase in drug theft, but there is currently no way of knowing if and when those drugs are resold back into the U.S. supply chain.


Alzheimer’s Association Support Group Coming To Rhea County

The Alzheimer’s Association support group in Rhea County will hold its kickoff meeting on Tuesday, April 29 at 5:30 p.m. at The Veranda Assisted Living Community. Alzheimer’s Association Education Liaison, Wendy Winters, will be the guest speaker for the initial meeting. The support group, facilitated by Melissa Wood, will hold regularly scheduled meetings on the fourth Tuesday ... (click for more)

9th Annual "Press Out Domestic Violence" Fundraiser Set For May 22

The ninth annual "Press Out Domestic Violence" fundraiser presented by the University of Tennessee College of Medicine - Chattanooga Transitional Year Residency Program and Erlanger Health System, will be Thursday, May 22, from 4:30-6:30 p.m. in the Erlanger Medical Mall. All proceeds will benefit the Partnership for Families, Children and Adults of Chattanooga. Since 2006, ... (click for more)

Haslam Signs Bill Ending Forced Annexation And Giving Tennesseans Right To Vote

Governor Bill Haslam signed HB 2371/SB2464 on Wednesday. The law ends forced annexations and gives Tennesseans the right to vote. The law now requires cities to annex by consent of the landowner or through referendum approved by a majority of the landowners to be annexed. As an additional protection to farmers, land primarily used for agriculture purposes may not be annexed by any ... (click for more)

One Of "Worst Of The Worst" Gets 10-Month Federal Sentence

One of the men labeled as the "worst of the worst" in a Chattanooga roundup was sentenced Tuesday to 10 months and three years supervised release after he pled guilty to one count of conspiracy to distribute crack cocaine. Guy Wilkerson told Federal Judge Sandy Mattice, "I'm just a young father and I want the best for my kids." He said he apologized and that he knew what he ... (click for more)

Time For Tennessee To Act On Climate This Earth Day - And Response

Tennessee will join the rest of the southeast region, the nation and countries across the world in celebrating Earth Day on April 22. The entire month of April is a great time to reflect on the strides we have made to reduce pollution over the last 44 years, and assess current environmental conditions while evaluating our personal responsibility to a cleaner environment.  ... (click for more)

Roy Exum: Why Jim Coppinger Excels

Jim Coppinger, who as the mayor of Hamilton County has understandably had to grow some thick skin, wants no part of the repulsive billboards now seen around town that ask, “Do you have gonorrhea?”  His Tuesday morning telephone call revealed he is just as disgusted as the rest of us who see them showing a picture of a forlorn African-American male. “You need to know the Hamilton ... (click for more)