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.


Candlelighters Family Support Group Golf Fundraiser To Be Held May 14

The 8th Annual Candlelighters Golf Tournament will be held on Saturday, May 14 at Brainerd Golf Course.  Tee-off time is 8 a.m.  Registration fee for a team of four is $300, which includes green fees, cart, team photo, breakfast, and lunch. "Candlelighters Family Support Group is a non-profit organization dedicated to helping families with a child stricken with childhood ... (click for more)

CHI Memorial Hosts Free Seminars On Surgical Weight Loss Options

Jack F. Rutledge, M.D. and CHI Memorial Metabolic and Bariatric Care will host two free seminars in May on surgical weight loss options. The seminars will be held at CHI Memorial Hospital in the community room on  Tuesday, May 10, a nd in Cleveland at Life Care Centers of America - Campbell Center on  Tuesday, May 24 .   Both seminars will begin at  ... (click for more)

Dewayne Ray Burns Wanted After Firing Shots At Fort Oglethorpe Police Officers

Dewayne Ray Burns is wanted after police in North Georgia were led on a chase, and he fired shots at officers. Burns fired shots in their direction late Thursday night. The Georgia Bureau of Investigation and the Fort Oglethorpe Police Department are investigating the incident. According to park rangers on the scene, the Burns ran away, while firing shots in the direction ... (click for more)

Bradley County Sheriff Eric Watson Hospitalized; 2 Cleveland Police Officers Injured After Altercation With Man With History Of Assaults

Bradley County Sheriff Eric Watson and two Cleveland Police officers were injured Thursday while intervening in a domestic assault in progress. While driving on 25 th St. N.W. Sheriff Watson witnessed the assault, it was stated. When the sheriff tried to intervene, the man involved in the assault attacked him. During the scuffle the man struck Sheriff Watson numerous times, ... (click for more)

Jill Levine Is An Educational Rock Star

No one has covered the Hamilton County Department of Education drama better than Roy Exum.  Thank you, Roy, but I take issue with your unnamed sources.  Professional jealousy and sour grape darts should not be anonymous.   HCDE is so dysfunctional, and there is good cause to place this public organization under a microscope, dissect it into pieces and discard all ... (click for more)

Roy Exum: Cancer Is Not A Battle

I read a marvelous essay not long ago where the author urged, “Stop telling the lie that cancer is a battle … a battle implies a fair fight, and there was nothing fair about my cancer or the cancer that took the life of my friend. Those experiences were about as fair as getting hit by a car – and nobody says people lose their battles with automobiles.” Mary Elizabeth Williams, ... (click for more)