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.

World AIDS Day Events Held Dec. 1 And 6

The Southeast TN Council for HIV/AIDS Care and Prevention, in partnership with the city of Chattanooga and The Hunter Museum of American Art, will host World AIDS Day 2015 events on Tuesday, Dec. 1, and Sunday, Dec. 6. These events will highlight the arc of the pandemic, how the southern United States is the epicenter of the domestic HIV/AIDS epidemic, the ... (click for more)

Free Metabolic Seminars Hosted By CHI Memorial Metabolic And Bariatric Care

Jack F. Rutledge, M.D. and CHI Memorial Metabolic and Bariatric Care will host two free seminars in December on surgical weight loss options. The first seminar will be held at CHI Memorial Hospital in the community room Tuesday, Dec. 1 at 6 p.m. The second seminar will be at the North River Civic Center in Hixson on Tuesday, Dec. 15 at 6 p.m. "Obesity can be devastating to ... (click for more)

Darrel Jones, 43, Shot And Killed On Central Avenue; Benson Critical In Another Of New Wave of Chattanooga Shootings

Darrel Jones, 43, was shot and killed on Central Avenue on Thursday afternoon. Then, early Friday morning, 34-year-old Desmond Benson was shot, leaving him in critical condition. as a wave of new Chattanooga shootings continued over the Thanksgiving holidays.  Chattanooga Police responded to the 3600 block of Central Avenue around 3 p.m. on a report of a ... (click for more)

Family Escapes Early Morning House Fire

A home was damaged by fire early Thursday morning.  The Chattanooga Fire Department received a fire call at  3:48  a.m.  and responded to 1825 Dixon Street with four fire companies. The family inside the home was awakened by a passerby knocking at the door. All of them quickly made their way outside the home to safety.  Once firefighters ... (click for more)

An Extra Helping Of Gratitude

After being thankful for the grace of God, my family and good health, this year I have an extra helping of gratitude to live in a special place called Chattanooga.   We endured the trauma of terrorism on July 16 and emerged more united and stronger than ever before.  We claim our heritage and celebrate our diversity like no other city in America.  We honor our ... (click for more)

Roy Exum: Cometh ‘The Black Dog’

I am one of 350 million people in the world who suffers from clinical depression. The doctors trace it back to my first decade of the 21 st century when constant surgeries and infections knocked me loopy but the more I have found, I believe I am more like Sir Winston Churchill, Abraham Lincoln and pro football star Terry Bradshaw – I think I have had it all my life. Today it ... (click for more)