Alexander: FDA “Off To A Fast Start” In Implementing New Law To Clarify Oversight Of Compounding Pharmacies

Thursday, March 13, 2014

At a Senate health committee hearing on Thursday with Food and Drug Administration Commissioner Margaret Hamburg, Senator Lamar Alexander, the committee’s Senior Republican, praised the Food and Drug Administration’s “fast start” in implementing the new law he worked to pass to help clarify oversight of compounding pharmacies.

“The FDA gets plenty of criticism, but I want to give credit where credit is due: you’ve responded to a crisis as if it were a crisis. You’re off to a fast start in implementing this important legislation and I appreciate that. Just one week after the legislation was signed into law, FDA published three guidance documents,” Senator Alexander said.

The new law is the result of a legislative agreement Senator Alexander helped reach between House and Senate health committees to make compounded sterile drugs safer. The law clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.

Senator Alexander said, “It has been a little over 100 days since the president signed the Drug Quality and Security Act, and in that time 30 facilities have registered as outsourcing facilities nationwide—they’ve done that voluntarily--and these 30 facilities all have done this without receiving guidance on the requirements they’ll have to meet for the sterile drugs they make. So that’s a good sign, and I believe that once we have more clarity, the number of outsourcing facilities will go up significantly.”

Commissioner Hamburg testified that the FDA is working on drafting the manufacturing guidelines that compounding facilities choosing to register with FDA will have to meet, and hoping to release them “as quickly as we can.”

FDA Commissioner Hamburg had testified to the committee in 2012 that if Congress failed to act, another crisis like the meningitis outbreak was “a matter of when, not if.”

At Thursday’s hearing, Senator Alexander said, “While the final legislation was not as strong as the bill that passed this committee, the law will make it clear that either the FDA or the state is overseeing each compounding facility.”

The law says that large facilities compounding sterile drugs without prescriptions now have the ability to voluntarily register with the FDA as “outsourcing facilities,” committing to higher standards for sterile compounded drugs, to report adverse events, put on certain labels, and to list all the products they make with the FDA. The legislation kept state oversight of traditional pharmacies – the corner drug store – and FDA oversight over drug manufacturers.

Senator Alexander asked Commissioner Hamburg on Thursday if the law was successfully making it clear “who’s on the flagpole” for oversight of facilities. Hamburg testified that the law was a “very, very important step forward in terms of that effort and also really defining a new role for the FDA.” She testified that the voluntary registration process means that some compounders will not register with FDA.

Commissioner Hamburg testified that FDA is strengthening its communication with states about the new system.

She added: “We’ve also been doing a lot of outreach with health care providers, hospital systems, etc., because we hope that they will see this—the outsourcing facility mechanism—as what is best for their patients in terms of assuring quality and regulatory oversight, and that it will become the standard of care and more and more companies will declare themselves to us and we will be able to work with them in this way.”

“That is my hope, too,” Senator Alexander said.



Morning Pointe Celebrates Dec. 14 Holiday Grand Opening In Spring Hill

Morning Pointe of Spring Hill will celebrate a holiday grand opening Dec. 14, from 4-7 p.m. at 1001 McCutcheon Creek Lane, located off Miles Johnson Parkway, south of Duplex Road. The event will begin with a formal ribbon cutting at 4:30 p.m., and will feature a Christmas Concert by Summit High School and a singing of songs from Charles Dickens’ “A Christmas Carol” by Columbia State ... (click for more)

CHI Memorial Mobile Health Coach To Visit Meigs And Sequatchie Counties

CHI Memorial’s mobile health coaches will provide mammography screenings on Friday, Dec. 1 at the Piggly Wiggly, 17619 State Hwy. 58 N. in Decatur, from 9 a.m.-4 p.m., and at the Sequatchie County Senior Center, 103 Heard St. in Dunlap, from 9 a.m.-1 p.m. CDT.   "All women should have one screening mammogram between the ages of 35-40. After age 40, a screening mammogram ... (click for more)

Hixson Burglary Suspect Tries To Swim Away; Deputies Catch Him In Borrowed Boat

A Hixson burglary suspect on Wednesday tried to swim away from deputies, but to no avail.   The proprietor of Chattanooga Fish and Fun was notified when his camera system was triggered by an individual attempting to break into his business. The owner immediately contacted the Sheriff's Office and drove to the business location.   As deputies arrived on scene, ... (click for more)

5 Disinherited Adopted Children Of Dr. J. Don Brock May Share In Rich Estate After All

Five disinherited adopted children of the late Chattanooga businessman J. Don Brock may share in his large estate after all. After losing at the trial court and appeals court level, the plaintiffs won a victory at the Tennessee Supreme Court. Justice Cornelia Clark ruled in favor of the adopted children and remanded the case to the trial court for settlement of the estate. ... (click for more)

Stormwater Fiasco And East Ridge Camping

When did the Chattanooga City Council get replaced by members of the East Ridge City Council? I don't recall a time in Chattanooga where they've voted to shoot the city in the foot more than they have lately.  If this goes through despite the environmental impact warnings and then Camp Jordan has increased flooding after spending millions on sports ball fields, ... (click for more)

Roy Exum: The Chicken Gun

On the very day when more poultry is consumed in the United States than at any other time in the year, fun-loving Wendell Burns shared a wonderful story about “The Chicken Gun.” What makes the tale even better is that it was designed and built to perfection by the folks at the Arnold Air Force Base that you know is near Tullahoma, Tn. Wendell’s mistake in sending the story is ... (click for more)