GxPs for the Holidays

December 12, 2010

GxP Perspectives

Happy Holidays from GxP Perspectives

GxP Perspectives wishes you, your family, friends & colleagues a wonderful holiday season. The Blog is taking a break until the new year but wants to leave you with a few tidbits of holiday cheer. First, there are just a few days left until the Trial Master File Reference Model Survey closes 16 December. I am attaching a link below. You can learn more about the TMF Reference Model on the TMF page aboove. Next, I am attaching links to a few blogs that I think are pretty good. Finally, I want to pass along an FDA warning to the fellows who might be seeking a little extra holiday cheer through the use of an herbal potion with the clever name of “Man Up Now.”

GxP Perspectives

Goodwill to All

Applied Clinical Trials: Their blog is one of the best.

Compliance Zen: “Practical FDA compliance insights and intelligence.”

FDA Law Blog: As described

FDA Matters: Keep up with what is happening at FDA in this blog from Steven Grossman

FDA Press Release on “Man Up Now.”

Please join GxP Perspectives on LinkedIn at:

GxP Perspectives LinkedIn Group

TMF Webinar on 20 January 2011

FDA Inspections: Will FDA’s New Food Safety Authority Leave Drugs & Devices Behind?

December 5, 2010

FDA authority food safety drug device inspection

FDA Food Safety:
How will it Impact Drug and Medical Device Inspections?

With the passage of the FDA Food Safety Modernization Act by the U.S. Senate, there has been concern that FDA will “choke on food” and not have adequate resources to conduct inspections of medical devices, human drugs, and biological products including vaccines. Although the bill still needs to reconciled between the House and Senate versions, funding is clearly going to be an issue as the new Congress is in a belt-tightening mood. Will FDA’s new food safety authority cut back on oversight of clinical trials and other drug and device inspections? This has been a discussion on the GxP Perspectives LinkedIn Group. My viewpoint is that the new food safety authority will not have an impact on Bioresearch Monitoring inspections (GCP & GLP) but probably will for routine GMP inspections of both pharma and device companies.

Why? The Bioresearch Monitoring (BIMO) program coordinates FDA inspections of Clinical Investigators, IRBs, Sponsors and/or CROs, Nonclinical Laboratories, and Bioequivalence/Bioanalytical research. The BIMO (pronounced bye-moe) inspections are coordinated, and payed for, by four FDA Centers; the Center Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER), and the Center for Veterinary Medicine (CVM) located at FDA’s headquarters in Silver Springs, MD. Remember, they have user fees from the Prescription Drug User Fee Act and the device user fee program. So if you are considering an application for approval, expect an FDA inspection.

Those of us in the drug and device development field often think that FDA’s primary authority is the approval of new health therapies. If you are an FDA employee at one of the Centers in Silver Springs, that just might be the case. However, the primary area the new FDA Food Safety and Modernization Act will impact is in the organization and management of the Office of Regulatory Affairs (ORA- the field organization) and the Center for Food Safety and Applied Nutrition.

FDA food authority drugs devices inspections

Bioresearch Monitoring is 5.4% of ORA's Workplan

Bioresearch Monitoring makes up around 5.4% of ORA’s workplan so it has never been their major focus. FDA has fallen behind in the biennial GMP inspection schedule for years, so I would anticipate that to continue, if not worsen. However, the mandated, and funded, inspections of clinical trials should continue unabated. Here are the numbers from the ORA Fiscal Year 2009 Workplan. (The new tobacco program is not included.) They show that food is the largest program. It always has been. ORA is funded by the Centers by the number of FTEs (full time equivalent employees) allocated by the centers to conduct inspections and laboratory analyses.

Food: 1,062 FTEs – 53% of Total
Human Drugs: 339 FTEs- (62.1 BIMO FTEs)
Medical Devices: 238 FTEs- (36 BIMO FTEs)
Vet Medicine: 118 FTEs- (4.4 BIMO FTEs)
Biologics: 115 FTEs- (4.4 BIMO FTEs)

TOTAL: 1,987 FTEs- (106.9 BIMO FTEs) – 5.4% of Total FTEs

These numbers tell an interesting story. ORA has 20 District Offices around the country. They also now have international offices for China, India, Europe, and Latin America. However, the primary focus is food, GMP, and import operations, not BIMO. Think about the amount of expertise and specialization the drug and device development industries require. There are times when one of the Centers will send specialists to work with an FDA BIMO Investigator. That is taking place more and more for sponsor inspections. Still, look at the numbers and do the math.

FDA food safety authority drug device inspections

FDA Needs Adequate Funding for Food, Drug & Device Inspections

I support passage of the FDA Food Safety Modernization Act. It will help FDA take Salmonella off of grocery store shelves and as a consumer I appreciate that. However, it is possible that drug and device GMP inspections might suffer. FDA BIMO inspections will continue at the same rate, but I am one to support a BIMO Modernization Act to help FDA update regulations and reorganize the inspection force. Most of all, FDA needs the funding to carry out the Food Safety Act as well as its other responsibilities, including GMP inspection of drug and device manufacturers and clinical trials.

ORA Workplans FY-2001 thru FY-2009

Update: Read Steven Grossman in FDA Matters on two strategies for FDA legislation in 2011.


Two Important New GCP Documents: There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

Please join GxP Perspectives on LinkedIn at:

GxP Perspectives LinkedIn Group

Visit the TMF Page at the Top Right of the Blog! I am trying to assemble resources for those of us concerned with the Trial Master File. I welcome any contributions you might have of interesting articles and resource documents.


In news from GxP Perspectives. I will be participating in the conference, Developing CAPAs in the GCP Environment on January 18-19, 2011 in Arlington, VA.

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