FDA Commissioner Quits!

In a surprise announcement on September 23, FDA Commissioner Dr. Lester Crawford, just confirmed in July, announced his immediate resignation. The revolving door to the Commissioner's office keeps spinning. Here's a brief history.

• 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)

Within an hour of Crawford's resignation, President Bush nominated National Cancer Institute Director Andrew von Eschenbach to serve as FDA's Acting Commissioner. Hmmm, you think the administration anticipated or even encouraged Crawford's resignation?

What does this mean for us?

More and continued uncertainty and tension at the top ranks of FDA. And as in most any organization, this trickles down to all levels. Expect FDA investigators to take a conservative stand - better safe than sorry. Don't expect to get the benefit of the doubt.

What should we do?

• First and foremost, be proactive in your GMP compliance efforts. Don't wait for FDA to come in and tell you what to do.
• Be sure that your systems and processes are in order. This is the time to conduct an internal audit and take corrective actions on any deficiencies exposed by your audit.
• Be sure that your GMP training is up to date. Conduct an audit of your training records. It's not unusual to find that certain individuals have missed key training sessions due to jury duty, disability leave, vacations, and other reasons people are away from work.
• Update your GMP training materials. Scroll down through our GMP Training Tips web portal - www.GMPTrainingSystems.blogspot.com. Our archived postings can provide you with ideas to improve and update your GMP training process. FDA's own website - www.FDA.gov - also provides useful material you can use in keeping your GMP training fresh.

www.GMPTrainingSystems.com

We design and conduct GMP and related training for the Pharmaceutical, Medical Device, and related industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, Glaxo SmithKline, Grifols Biologicals, and several others.

GMP for PET Drugs Proposed by FDA

The Food and Drug Administration (FDA) just announced a proposed current good manufacturing practices (CGMP) regulation for the production of Positron Emission Tomography (PET) drugs.

Positron emision tomography is a medical imaging modality involving the use of radiopharmaceutical drug products. The majority of PET drug products are injected intravenously into patients for diagnostic purposes. Most PET drugs are produced at locations that are close to the patients to whom the drugs are administered (e.g. in hospitals or academic institutions). Due to their short half-lives, PET drugs usually are administered within a few minutes or hours of production.

In the announcement, FDA defines the difference between a Rule or Regulation and a Guidance Document.

They say that rules state binding requirements and are enforceable in the courts. A guidance describes FDA’s current thinking on an issue, recommending approaches which, if followed by industry, would in our judgment meet the requirements set forth in the regulations. Guidances do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA. (Note: Our experience has shown that FDA expects us to comply with Guidances pretty much to the same degree that we comply with Rules/Regulations.)

Find FDA's announcement about PET cGMPs and supporting documentation at www.GMPTrainingSystems.com/asp/articles.asp Scroll down to the section marked cGMP for PET.

www.GMPTrainingSystems.com

We design and conduct GMP and related training for the Pharmaceutical, Medical Device, and related industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, Glaxo SmithKline, Grifols Biologicals, and several others.