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.


Morning Pointe To Host "Springtime Storytime" Event With Read20

On  April 14 , from  3-5 p.m. ,  Morning Pointe of Collegedale at Greenbriar Cove, at 9650 Leyland Drive, in Collegedale, invites children ages Pre-K to 6th Grade for snacks and story time. The event is open to the public. Space is limited to 70 children. Please call  423 396-6999  to RSVP to ensure enough books are available for each child. (click for more)

CHI Memorial Mobile Health Coach To Visit Cleveland For RAM Clinic

CHI Memorial’s mobile health coach will provide mammography screenings at the Remote Area Medical (RAM) Clinic at Cleveland High School, 850 Raider Dr. NW, on Saturday, April 1 from 7:30 a.m.-3:30 p.m. and on Sunday, April 2 from 7:30 a.m.-2:30 p.m.   "All women should have one screening mammogram between the ages of 35-40. After age 40, a screening mammogram is recommended ... (click for more)

Boyd Says $4.1 Million In County Budget Cuts Would Yield $43.1 Million For School Projects; Proposes That CSLA Move To Dalewood

County Commission Finance Chairman Tim Boyd on Wednesday recommended $4.1 million in county budget cuts, which he said would provide bond funds for $43,150,000 in county school projects. He recommended that $250,000 of the money from the cuts go to relocating Chattanooga School for the Liberal Arts (CSLA) to Dalewood Middle School. He said Dalewood students could move to a portion ... (click for more)

Police Shoot And Kill Sheriff's Office Employee, Daniel Hendrix After Disorder At Brainerd Home; 2 Off-Duty City Officers Were At Scene Of Altercation Where Shot Was Fired

Chattanooga Police responded to an altercation at a house in Brainerd early Wednesday morning and wound up shooting and killing an armed man, who is an employee of the Hamilton County Sheriff's Office. Police said two off-duty Chattanooga Police officers were at the scene of the disorder in the 300 block of Shawnee Trail. A shot was fired before officers arrived at 1:26 a.m. ... (click for more)

Slaxxon Regret - And Response

Back in the seventies my three oldest brothers had a buddy named Steve Slack. “Slack” was a star soccer player at Baylor and he grew up on Lookout Mountain, which is where I grew up. He and Jimmy, Henry and Bill went to the University of Virginia where they were roommates in an old, beat up house that was painted pink. Naturally, the place became known as the “Pink Palace” but lest ... (click for more)

Roy Exum: OK, Sis, Off You Go

I’ve got to do something to adjust my sense of humor but fear there is not a big enough wrench. Rasmea Yousef Odeh, who is a naturalized American citizen from Jordan, was one of the principal figures in January’s Women’s March on Washington and had an equal starring role in the most recent “Day Without Women” protests in America. I’m all for equal rights for women yet I was appalled ... (click for more)