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.


CHI Memorial Foundation Announces 2015-2016 Board Of Directors

CHI Memorial Foundation, the fundraising arm of CHI Memorial, announce officers and members of the board of directors.  MaryStewart Lewis, has been named chair of CHI Memorial Foundation. Dr. Bill Stacy, continues his service as immediate past chair. Hodgen Mainda will serve as secretary, and Dawn Shea will serve as treasurer. Members at large include Leo Brown and Lee ... (click for more)

Erlanger Bariatric Sugery Center Earns Three-Year Accreditation

Erlanger Health System’s Metabolic and Bariatric Surgery Center has achieved a three-year accreditation from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), a  joint program of the AmericanCollege of Surgeons and the American Society for Metabolic and Bariatric Surgery.   In addition, ... (click for more)

Sheriff Watson Offers To Send Team To Colorado To Help With Search For Cleveland's Joe Keller; Active Search Suspended

Bradley County Sheriff Eric Watson has offered to send a Special Response Team, as well as other resources, to help Colorado authorities, who have suspended their search for 19-year-old Joseph Keller. He noted, "Joe Keller is a well-known young man who has lived in the Bradley County area, and disappeared while on a run in Conejos County, Colorado recently. " Sheriff ... (click for more)

Bicycle Store Owner Helps Police Nab Burglary Suspect

A bicycle store owner helped police nab a burglary suspect. Paul Rene Hayes, who has an extensive criminal record dating to 1993, was charged with aggravated burglary. Police investigated a burglary on July 21 at a house on Kelly's Ferry Road. The owner left his house at 8:45 a.m. and returned at 7 p.m. He found that his front door had been kicked in. He was missing his ... (click for more)

Why Is The City Diverting Federal Transportation Funds From Real Need?

The city of Chattanooga and CBL, owner of Hamilton Place Mall, would have the mass of taxpayers believe that improving mall access from the interstate is not impacting us financially.   Namely, CBL has committed to fund the city’s match of $8 million, so they will receive $32 million in Federal Transportation Funds that are allocated annually to local jurisdictions through ... (click for more)

Roy Exum: A Very Silly Apology

It didn’t get a lot of attention, as well it should not have, but when I heard Japanese giant Mitsubishi was offered an apology for heinous war crimes that took place during World War II, I thought it was an ill-conceived publicity stunt. But, no, in a solemn ceremony last month hosted by the Museum of Tolerance at the Simon Wiesenthal Center in Los Angeles, that is exactly what ... (click for more)