Thursday, March 30, 2006

FDA talks about GMPs

Scott Gottlieb, MD, FDA's Deputy Commissioner for Medical and Scientific Affairs addressed the 30th International Good Manufacturing Practices Conference at the University of Georgia College of Pharmacy on March 14, 2006.

His remarks provide insights into what the Agency is thinking. Here's what he said about the GMP regulations.

"The truth is there are important regulatory and technical questions that need to be addressed. But our GMP regulations for drugs haven’t been updated in 25 years. Meanwhile, best practices in manufacturing technologies and methods have undergone significant progress over that time, particularly in other high-tech industries.

For example, the semiconductor industry like the drug industry also has a very low tolerance for impurities and inaccuracies in production. And when its production processes were lagging because of high costs and too many errors that industry helped invent the "six sigma" production methods. Through continuous quality improvement, those methods achieved enormous improvements in production cost and quality, and they have since been widely adopted in manufacturing industries.

But manufacturing hasn’t received its due attention in the pharmaceutical industry, even though many experts on manufacturing processes including many of you here today believe that large savings in production costs could be realized while achieving even higher quality standards. That needs to change. And we need to make sure that our regulations are encouraging and facilitating such progress, which is needed today more than ever."

The good news here is FDA's focus on updating the regulations to encourage and facilitate progress in manufacturing. Stay tuned!

Read Dr. Gottlieb's entire remarks at www.GMPTrainingSystems.com/asp/resources.asp

GMP Training Systems, Inc.
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Our April GMP Boot Camp is full. Our next GMP Boot Camp is scheduled for May 17 - 18 in Newport News, Virginia. Find out how you can attend at www.gmptrainingsystems.com/asp/public_workshops.asp

Thursday, March 23, 2006

Regulation of Dietary Supplements

It's often useful to check FDA's website - www.FDA.gov - from time to time to gain insights into how the Agency thinks. On March 9, 2006, the Director of FDA's Center for Food Safety and Applied Nutrition testified before a Congressional committee focused on "The Regulation of Dietary Supplements: A Review of Consumer Safeguards."

(Do you think the news about steroids and certain baseball players had anything to do with this hearing?)

You can read the Director's testimony yourself and learn a bit about how FDA is thinking these days.

Go to www.GMPTrainingSystems.com/asp/resources.asp where you can download a document containing the testimony.

One important piece of this testimony is the following:

"From October 2002 through February 2006, FDA has conducted 588 domestic inspections of dietary supplement manufacturers, issued more than 350 "warning letters" and "cyber letters" to marketers of dietary supplement products, seized products worth more than $13.4 million, supervised the voluntary destruction of more than $3 million worth of products marketed as dietary supplements that were promoted with unsubstantiated claims or that were unapproved drugs or were unsafe, and obtained permanent injunctions against five firms distributing misbranded or unapproved drugs as dietary supplements."

For manufacturers of dietary supplements, the above statistics indicate that they have much work to do to become compliant.

GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com

Thursday, March 16, 2006

FDA Commissioner - From Acting to Permanent?

The FDA is sorely in need of a permanent Commissioner who will stay in the job more than a year or two. The position has been a revolving door since David Kessler left in 1997. It's not likely the latest move will be the solution. Consider the following breaking news.

On March 15, the White House announced the nomination of Andrew von Eschenbach to be the permanent commissioner of the FDA. Von Eschenbach has been the acting head of FDA since former commissioner Lester Crawford resigned in September 2005. As acting head, von Eschenbach’s decision to keep his job as chief of the National Cancer Institute has raised criticism and conflict-of-interest concerns; if confirmed by the Senate he will have to leave the NCI.

This time the nomination process is mired in politics. Read the following statement issued within hours of the formal nomination.

"It is past time for the FDA to stop dragging its heels and make a decision on Plan B," Sen. Hillary Clinton (D-New York)wrote in a joint statement with Sen. Patty Murray (D-Washington). "We will place a hold on the nomination of Dr. von Eschenbach until the FDA issues a decision on Plan B, yes or no."

Plan B is the OTC morning-after contraceptive.

The hold means Von Eschenbach may never be confirmed by the Senate during Bush's term. "The FDA needs a full-time commissioner," said White House spokesman Ken Lisaius. "We hope the Senate gives the nominee timely consideration and provides him with an up-or-down vote."

Here's a brief summary of FDA's leadership since 1990.
  • David Kessler 1990 - 1997
  • Lester Crawford 1997 - 1999 Acting Commissioner
  • Jane Henney 1999 - 2001 (2 years)
  • Lester Crawford 2001 - 2002 Acting Commissioner
  • Mark McClellan 2002 - 2004 (16 months)
  • Lester Crawford 2004 - 2005 Acting Commissioner
  • Lester Crawford July 2005 - Sept 2005 (2 1/2 months)
  • Andrew von Eschenbach - Sept 2005 - Present Acting Commissioner, and still head of the National Cancer Institute
What does this mean for us?

Continuing confusion in dealing with FDA. The burden of proving that we are in control of our systems and processes has always fallen on industry, and it's in industry's best interest to be prepared to demonstate to FDA that our control systems work and we have confidence that we are operating our business in a state of control. This means being GMP compliant across the board.

GMP Training Systems, Inc.
Experience You Can Trust
www.GMPTrainingSystems.com

Tuesday, March 14, 2006

Today in FDA History

March 15, 1912

Dr. Harvey W. Wiley resigns as chief of the U.S. Department of Agriculture's Bureau of Chemistry, the federal agency that eventually became the FDA. Wiley had been serving as chief chemist since 1883. Wiley's crusade for stronger national food and drug regulation earned him the title "The Father of the 1906 Pure Food and Drugs Act." After leaving the bureau, Wiley continued serving the American public as director of the laboratories of Good Housekeeping Magazine, where he established the Good Housekeeping Seal of Approval.

In 2002, Congress designated the building housing the FDA's Center for Food Safety and Applied Nutrition's new state-of-the-art laboratories and offices in College Park, Md., as the "Harvey W. Wiley Federal Building" in honor of the agency's first leader.

GMP Training Systems, Inc.
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www.GMPTrainingSystems.com

Our GMP Boot Camp is filling up fast.
April 5 - 6 in Anaheim, California. To learn more, go to www.gmptrainingsystems.com/asp/public_workshops.asp