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.

Diabetes Awareness Seminar Offered Nov. 5

There will be a Diabetes Awareness Seminar in the Ridgeside/Menlo Park Community in Brainerd on Saturday, Nov. 5, from 11 a.m.–1 p.m.  The seminar will be held at Greater Emmanuel Church, 400 Tunnel Blvd., and everyone is invited to attend this free event.   Registered nurses will provide:  updated diabetes awareness and maintenance information, blood pressure ... (click for more)

CADAS Recognized As One Of Tennessee’s Best By THDA

A sober-living facility being built by the Council for Alcohol and Drug Abuse Services was the focus of a Tennessee’s Best award Chattanooga-based nonprofit received last week during the 2016 Governor’s Housing Conference in Nashville. CADAS earned the Tennessee’s Best award from the Tennessee Housing Development Agency in the Housing Plus category. The Tennessee’s ... (click for more)

Fire Displaces Family Of 7; Blaze Ruled Accidental

No injuries were reported in connection with a house fire on Saturday afternoon that displaced a family of seven. The Chattanooga Fire Department received the alarm at 4:11 p.m. and responded to 3308 Dodson Ave. with five fire companies. Captain Wadie Suttles with Engine 4 said heavy fire was showing when the first firefighters arrived on the scene. As additional firefighters ... (click for more)

Clarence Ross, Leshawn Witherow Shot On Walden Avenue Friday Afternoon

Chattanooga Police are investigating a shooting that happened early Friday afternoon at the 6300 block of Walden Avenue.  Clarence Ross, 41, And Leshawn Witherow, 40, suffered non-life threatening injuries.  Hamilton County EMS transported both victims to a local hospital for treatment.  There is no suspect information at this time.  Investigators with ... (click for more)

Where Is The Speed Control On Our Highways? - And Response (2)

I am teaching my 15-year-old to drive in the North Georgia and Chattanooga area. I have warned her of the dangers of exceeding the speed limit both as a hazard to herself and in terms of receiving a ticket. What a liar I am.  Have you driven on the local freeways and highways recently? I never see any highway patrolmen helping to reduce speeding or pulling over those who ... (click for more)

Roy Exum: A Vol Is Worth $521,854

The definition for the term “fair market value,” this from the IRS tax code, “is the price at which the property would change hands between a willing buyer and a willing seller, neither being under any compulsion to buy or to sell and both having reasonable knowledge of relevant facts.” So a recent article in Business Insider has just revealed a University of Tennessee scholarship ... (click for more)