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FDA Reorganization Plans New

On Friday, August 17, 2007, FDA at least temporarily dropped its ill-advised reorganization plan for their field force. Margaret Glavin, Associate Commissioner for Regulatory Affairs (ACRA), and head of the agency field force, told employees that "To assure our success and allow additional time to gather input, I am cancelling plans for the rollout of all changes to our organizational structure." Michigan Representative Bart Stupak said in response that "If it had been implemented, the FDA's plan could have put the American public health at an even greater risk." There was major opposition to FDA's reorganization plan in both the House and Senate, from both political parties. It is possible that agency leaders will continue to plan for a future reorganization. The agency has recently announced that they are planning on outsourcing 322 jobs, a plan which has also met with Congressional opposition.

Reorganization Details
FDA had planned to eliminate nearly half of its field offices, including its five regional offices, 7 of its 13 laboratories, and four of its 20 district offices, including those in industry hubs of New Jersey and Puerto Rico. The reorganization was to be complete by October 1, 2007, with the labs closing in FY 08 and 09. In mid-July 2007, a hearing on food safety and the field reorganization was held by the House Committee on Energy and Commerce, which has oversight jurisdiction over FDA (link below). In the hearing, a panel of experienced FDA field staff testified to the risk to the public if the reorganization proceeds, and what would be lost if the reorganization went through as planned. FDA Commissioner, Andrew von Eschenbach, and Margaret Glavin also testified, but neither provided adequate justification for the planned reorganization or lab closures.

District offices that were to have been closed or merged included New Jersey to Philadelphia, Detroit to Cincinnati, San Juan, Puerto Rico to Florida, and Kansas City to Denver. Regional offices that would have closed were in Atlanta, Dallas, New York (Jamaica), Philadelphia, and San Francisco (Oakland). If the plan were enacted, at least 260 FDA employees, including 200 lab analysts, would have lost their jobs, unless they were willing to relocate or apply for other open, agency positions. Field management was to have been centralized to report to the ACRA via two deputies: a Deputy for Operations, and a Deputy for Policy and Risk Management. All field staff were to have reported to the Deputy for Operations, the districts via a new Inspectorate and Compliance Directorate, and the remaining labs via a new Science Directorate. Imports were also to have been reorganized to report into a new Import Directorate. The surviving labs would have been in Atlanta, Cincinnati, Jefferson, AR, Los Angeles, New York City, and Seattle.

FDA's lab staff already declined 24% from 2003-2007. The reorganization would have reduced agency lab staff an additional 37%. The reorganization plan called for reducing field compliance officers to 10, meaning that there would not have been a compliance officer in every district. Although the Commissioner had proposed hiring 90 new investigators, at least 230 have resigned in the last four years. Total field staffing has fallen from a high of 4,004 employees in FY 03 to an estimated 3,182 or more employees in FY 07 -- nearly a 25% drop in four years. Glavin has had 66% turnover in her direct reports or deputies in 1-2 years. Since the reorganization was announced, and the agency began implementing it (despite opposition from Congress), two experienced regional directors have also retired or announced their resignation. There are currently about 1100 FDA inspectors, another 150-200 criminal investigators, and 700 lab employees. Because of insufficient funds, ORA has been unable to hire new employees or replace retiring employees for three years. Thirty percent of FDA's entire staff are eligible for retirement. Without hiring many new employees now, FDA will be unable to have experienced staff train the investigators, field managers, compliance officers, and lab analysts of the future. Despite knowing this, the Commissioner has not asked for a dramatic increase in funding for the agency. Congress, however, has proposed a $100-200 million increase for FDA for FY 08, and is considering legislation to dramatically increase the funding for food safety. FDA needs funding to fully implement the planned reorganization. Congress had also included language in FY 08 funding bills in both the House and the Senate to prohibit the reorganization, and had introduced legislation to ensure FDA did not implement the reorganization as planned (in a draft Food and Drug Import Safety Act of 2007, see link below). Congress had also asked the Government Accountability Office (GAO) to investigate the planned reorganization. The Commissioner and Glavin had previously announced that they were temporarily suspending the lab closures, district office closures, and reorganization of imports, supposedly to wait for the results of a presidential working group on imports that was initiated a day after the latest Congressional hearing. The announcement to cancel the roll-out of the field reorganization is very welcome. However, it would have been better if agency leaders had never floated such a flawed plan. It also remains to be seen whether agency leaders continue to plan a reorganization, despite opposition from those who fund them.

Most recent hearing

Proposed bill

Immel Resources believes the real reason behind the proposed reorganization is deregulation, the desire of the Administration to reduce enforcement of the industry, and to allow the industry to self regulate. FDA is severely underfunded. FDA regulates 25 cents of every dollar spent in the U.S. on food, drugs, medical devices, biologics, animal foods and drugs, and cosmetics, with a budget of less than $2 billion U.S. and approximately 9,000 employees. FDA's budget is the same as that of a single, large school district in the U.S. In an era of significant consumer concern over food and drug safety, including melamine in pet food, antifreeze in toothpaste, E coli in spinach, salmonella in peanut butter, and contaminants in imported fish, not to mention concerns expressed about the approved drugs Vioxx, Ketek, and Avandia -- and the 2004 loss of half of the U.S. flu vaccine supply due to contamination -- this proposal is unconscionable. Let's hope FDA senior management once again remember that their primary mission is to protect the American people.

FDA No Longer Enforcing GLPs for Devices

Another controversial subject is that FDA's Center for Devices and Radiological Health (CDRH) recently announced that they are no longer enforcing good laboratory practice (GLP) regulations for devices (21 CFR 58). FDA announced the policy change in May 2007 at the Annual Meeting for the Society for Quality Assurance. An agency representative said that FDA does not intend to take enforcement action if a nonclinical laboratory is not following GLPs. Immel Resources has confirmed this information. Although CDRH may still perform audits of GLP and non-GLP studies, they will be performing a data audit and data verification, rather than focusing on GLP requirements. Other comments made by the agency, when discussing their Device GLP Program Status, include the following:

* Historically, CDRH review divisions have not required animal safety studies to follow GLP
* Many marketed devices did not follow GLP
* Not feasible to require current manufacturers to follow GLP, especially if showing equivalence to predicate
* Inspections may be issued for non-GLP or GLP animal studies
* Focus on data audit or verification
* Less emphasis on GLP requirements
* More emphasis on auditing safety studies that support high-risk products
* OAI (inspections rated official action indicated, leading to enforcement action) applies to sites with data reliability issues, data falsification, omission, etc.

Immel Resources has heard the following comments about the policy change from experienced GLP experts: That GLPs are critical for determining which experimental therapies are safe to test in clinical trials or research in people, that this policy change will have a significant negative impact on the quality of the data submitted to FDA in support of device applications, and that failure to have data integrity at the beginning of research will affect the quality of data throughout the clinical trials and into the initial postmarket surveillance. Other comments are that the problem with not enforcing regulations is that you remove an enforceable standard for how research is conducted and the question is, Where does this stop? At what point does safety testing of medical devices, drugs, and biologics (and food additives) become unnecessary? Reactions from another GLP expert are that they were surprised FDA would put such statements in writing in a presentation, adding that regulations have the force of law and bind both the agency and the public, and that the agency cannot ignore its own regulations. They added that the argument that GLPs don't fit devices or that companies are small and can't afford to comply is bogus, and asked that if you're a clinical subject you should only participate in trials sponsored by big companies? They concluded that the bottom line is that subjects in device clinical studies and the public deserve the same level of safety testing as that required in pharmaceutical trials.

Immel Resources LLC would like to remind readers that the U.S. GLP regulations must be followed during "nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products." Compliance with the GLPs "is intended to assure the quality and integrity of the safety data." Although FDA can and does exercise enforcement discretion, until the existing regulation is modified or rescinded, it must be followed. Other world GLPs include OECD GLPs and Japanese GLPs; see also the Global Regulatory Links section below.

Final cGMPs for Dietary Supplements

A third controversial subject is that FDA recently published its final regulation for current, good manufacturing practices (cGMPs) for dietary supplements. A copy of the rule is shown below. The agency stated in its press release announcing the final rule that "to limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with more than 500 employees have until June 2008 to comply, companies with less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations."

At the same time, FDA published an interim final rule allowing manufacturers to petition the agency to not perform 100% identity testing of their ingredients. A copy of the interim final rule is shown below. The interim final rule includes instructions on how to submit comments to FDA and possibly affect the outcome of the interim final rule. If your organization is involved in manufacturing dietary supplements, we also highly recommend reading the preamble to the regulation (the opening section), which discusses comments the agency received and their thinking regarding the comments.

Many people believe that the final rule is a watered down version of the proposed rule. The final rule does not require a quality control unit (even though the proposed rule did), and does not require that all batches of finished product be tested to ensure that they conform to specifications before the batch is released (in the weaker, final rule, a subset of finished batches may be tested instead). It is hard to see how this rule will ensure the quality and safety of dietary supplements.

cGMP regulation

Interim final rule

Proposed rule


Fact sheet

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We all must remain current with FDA trends and industry practice. To avoid compliance problems with FDA and world regulatory agencies, call us today, toll-free at (866) 778-7222 in the U.S., or at +1 (707) 778-7222, or email us at immel@immel.com. Since 1996, we have helped many companies improve their compliance track records. We are known as quality systems experts.


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P.S. Call us today! All participants in our training classes receive a wealth of resource materials, including pertinent regulations and guidance documents, and copies of our well-respected articles. Thank you very much, and we look forward to serving you.

CAPA Classes in 2007

CAPA systems are an area of intense FDA scrutiny. More than 50% of FDA Form 483 observations and warning letters cite CAPA deficiencies. When FDA inspectors identify problems with a CAPA system, they will inevitably target the organization's entire quality system. In partnership with FDAnews, Immel Resources is presenting four sessions of our Conducting Bulletproof CAPA Investigations class this year:

  • March 21-23, 2007                San Juan, Puerto Rico
  • June 27-28, 2007                   Minneapolis, Minnesota
  • October 3-5, 2007                 San Diego, California
  • November 14-16, 2007          Raleigh, North Carolina
Here's the intensive CAPA training you've been looking for. There's no fluff and theory in this workshop. You'll roll up your sleeves to dig into 2 and 1/2 days of skill building interactive exercises, case studies, small group discussions, and mock presentations. The course brochure is available as a PDF file. For further information or to register for the course, please contact FDAnews toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.  If you would like to read one of our recent CAPA articles, please see our "Best Practices: Managing a CAPA System" article below under Latest Articles.

Second Annual FDA Inspections SummitNew

Mark your calendars -- the next FDA Inspections Summit will be held October 22-24, 2007 at the Marriott Bethesda North Hotel and Conference Center. The conference is being hosted by FDAnews. Last year's inaugural conference drew a stellar group of participants from many pharmaceutical, biologics, and medical device companies worldwide -- and a stellar list of speakers, many of them current and former FDA. The conference features three tracks: drugs and biologics, medical devices, and clinical trials. Barbara Immel, president of Immel Resources LLC, has been asked to serve as conference chairperson once again, and is delighted to be planning the conference with Jeff Grizzel, Craig Rotzler, and James Culp of FDAnews. We hope that you can join us.

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Barbara Immel, editor, served as a well-respected compliance columnist for BioPharm International for more than 10 years, and published her first article in an industry trade journal, Medical Device & Diagnostic Industry, 18 years ago. She is also a graduate and alumna of the Stanford Professional Publishing Course.

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Latest articles

The following are our latest articles in the trade press:

International Biologic Requirements and FDA Budget Cuts
"Compliance Briefing: Increased International Requirements and FDA Cuts," BioPharm International, February 2007
This article discusses new, international regulatory requirements for biologic products sold in Canada, Japan, and Europe. Article also briefly discusses FDA's inadequate funding and two advocacy groups that have formed to request sufficient funding from Congress, FDA Alliance (www.strengthenFDA.org) and Coaltion for a Stronger FDA (www.fdacoalition.org).

Clinical Trials (Device Emphasis)

"Building Quality into Device Clinical Trials, Part 1," Medical Device & Diagnostic Industry, July 2006
"Building Quality into Device Clinical Trials, Part 2," Medical Device & Diagnostic Industry, October 2006
These articles were written in collaboration with FDA's Bioresearch Monitoring experts in their Center for Devices and Radiological Health, and are based on an earlier FDLI/Clinical Device Group webinar in which FDA speakers presented on this topic.The first article discusses how to better ensure human subject protection and strengthen the sponsor-IRB relationship. It includes deficiencies found during FDA inspections of sponsors, clinical investigators, and institutional review boards. The second article discusses sponsor responsibilities in detail, including tips on selecting investigators, training and re-training, developing the protocol and preventing protocol violations, recordkeeping, and ensuring compliance. Also covered are tips on organizing a submission to expedite FDA review.

Investigational Drugs and Biologics
"Chipping Away at the GMPs: FDA's Phase 1 Proposals," BioProcess International, September 2006 (free registration required)
This article provides compelling reasons why the agency's proposal to exempt phase 1 investigational drug and biologics from the CGMP regulation was flawed. Because of significant adverse comment received from the public, FDA withdrew their direct final rule. For more information, please see the article above and the section below, FDA Withdraws Phase 1 Direct Final Rule.

FDA Inspection Trends and Compliance Tips
"Current Trends in FDA Inspection Findings and How to Avoid Compliance Pitfalls," BioPharm International Global Compliance Supplement, September 2006
This article provides current FDA inspection trends (common deficiencies cited on FDA Form 483s) concerning good laboratory practices, good clinical practices, and good manufacturing practices for drugs, biologics, medical devices, and active pharmaceutical ingredients. Article also provides tips on internal auditing and recommended training ideas, and has a thorough reference list of recommended FDA compliance resources.

"Best Practices: Managing a CAPA System," Medical Device & Diagnostic Industry, June 2006
Article discusses how to establish and maintain a robust corrective and preventive action system, including tips on selecting data sources, analyzing data regularly, investing in necessary resources, handling investigations and taking appropriate action, documenting and implementing CAPA, and communicating the CAPA. It also includes key practices and 20 tips on training employees how to conduct a problem investigation.

Problem Investigations
On Problem Investigations, Part 1, BioProcess International, April 2003 (article search and free registration required)
On Problem Investigations, Part 2, BioProcess International, May 2003 (article search and free registration required)
Part 1 explains when an investigation is warranted, and provides root cause analysis basics, required timelines for investigations, and ideas for investigation procedures. Part 2 discusses how to analyze, research, and document a problem investigation. Article provides tips on conducting problem investigations and provides recommendations from our well-received workshops on conducting investigations.

Electronic Records
"Part 11: New Guidance Provides Little Guidance," Medical Device & Diagnostic Industry, January 2004
Article discusses FDA's current approach to 21 CFR Part 11, Electronic Records, Electronic Signatures, including their use of enforcement discretion. Article has a checklist on how to implement Part 11 (a Part 11 plan), as well as inventory form ideas and recommended resources on Part 11. For more information on Part 11, please see the article above and the Electronic Records Implementation page in the Library/Resources section of this website. The regulation and recent FDA guidance narrowing the scope of the rule are available below under Global Regulatory Links.

FDA Withdraws Phase 1 Direct Final Rule

As you may know, the U.S. Food and Drug Administration withdrew their direct final rule to exempt phase 1 material from the CGMP regulation in Spring 2006. FDA withdrew the rule because they received significant adverse comment. Under FDA's direct final rule procedures, the receipt of any significant adverse comment will result in the withdrawal of the direct final rule. Had FDA not received significant adverse comment, the rule would have gone into effect, and phase 1 material would have been exempted from the CGMP regulation.

FDA has said that comments that they have received regarding the withdrawn rule will be considered in developing a final rule using the usual notice-and-comment procedures. The proposed rule and the draft guidance, INDs -- Approaches to Complying with CGMP During Phase 1, have not been withdrawn. Immel Resources hopes that the agency will use the comments received to develop proposed GMPs for investigational drugs, as the agency had always considered doing. The CGMP regulation, 21 CFR 210/211, is legally binding and must be followed during the manufacture of clinical (phases I-IV) and commercial drug and therapeutic biologic products intended for use in the United States. Guidance documents are not legally binding, and offer guidance only.

Links to the FDA documents are shown below, with a link to a tutorial that we presented in Spring 2006 at the GMP Conference at the University of Georgia, prior to the withdrawal of the rule. Also provided is a link to one of our most popular articles, "A Brief History of the GMPs: The Power of Storytelling." BioProcess International ran an article based on our comments to FDA concerning their proposal to exempt phase 1 investigational material from the CGMP regulation in their September 2006 issue. Special thanks to Anne Montgomery, editor of BioProcess International, for asking to reprint our comments. That article may be accessed here (free registration required) or above under Latest Articles.


Chipping Away at the GMPs: Understanding FDA's Proposal to Exempt Material for Phase 1 Clinical Trials from CGMP Regulations, and new Draft Guidance

A Brief History of the GMPs: The Power of Storytelling (pdf)
Direct Final Rule
Current Good Manufacturing Practice Regulation and Investigational New Drugs; Direct Final Rule

Proposed Rule

Current Good Manufacturing Practice Regulation and Investigational New Drugs; Companion Document to Direct Final Rule

Draft Guidance
INDs -- Approaches to Complying with CGMP During Phase I (pdf)

Global Regulatory Links

For your convenience, here are useful links. This is not intended to be an all-inclusive list, nor to replace the advice of an experienced quality assurance or regulatory compliance professional. Please note:  This information was current at the time that it was posted on this web site. Please ensure that you are using the most current version of these documents, and following all applicable regulations.

European Union

Pharmaceutical GMPs

Medical Device Directives

Active Implantable Medical Devices (AIMDD)
Medical Device Directive (MDD)
In Vitro Diagnostic Directive (IVDD)



          Ministry of Health, Labor and Welfare (English index)

          To purchase English-language translations of newly revised pharmaceutical and medical device GMPs:
          MHLW Ministerial Ordinances on GQP and GMP 2005, and
          Pharmaceutical Affairs Law, Enforcement Ordinance and Enforcement Regulations 2005/07
          In hard copy:  Balogh International

          Online/electronic:    Jouhou Koukai

          Pharmaceutical GMPs in a CD-ROM with other international pharmaceutical requirements: Drumbeat Dimensions

World Health Organization



United States

Drug cGMPs

For human and animal drugs, therapeutic biologics, and as guide to active pharmaceutical ingredients

Revision of Certain Labeling Controls

Preparation of investigational materials
All clinical material for the U.S. must be produced according to current good manufacturing practices.

Aseptic Processing Guidance

Final Guidance: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Guideline on General Principles of Process Validation

FDA Compliance Program Guidance Manual on Drug Manufacturing Inspections

FDA Compliance Program Guidance Manual on Inspections of Licensed, Therapeutic Biologics

Medical Device CGMPs

Blood Product CGMPs

Blood and blood components


Food CGMPs

Veterinary Biologics

Facility requirements for licensed veterinary biologics

Dietary Supplement cGMPs
          For a discussion of the new rule, see also the top of this page. 

Human Tissue

Good tissue practice (final rule)

Medical Gases

GMP draft guidance

Part 11 Electronic Records, Electronic Signatures

Good Laboratory Practices (GLPs)

          U.S. GLPs

          FDA Compliance Program Guidance Manual on GLPs

          OECD GLPs

          OECD GLP Guidance Documents

Good Clinical Practices (GCPs)

HIPAA Regulations

Other Useful Guidances (a partial list)

ICH Guidelines

Active Pharmaceutical Ingredients

Compliance Resources

Although we recommend all of the above resources, some of our other favorite FDA resources include the following:

FDA Enforcement Story
Issued annually, this document contains excellent information to include in a senior management compliance briefing or advanced CGMP training class.

FDA Compliance Program Guidance Manual (CPGM)
The CPGM provides instructions for FDA staff, and contain questions that you may be asked in your next inspection. Sections are available for foods, cosmetics, biologics, bioresearch monitoring (GLP/GCP compliance), drugs, veterinary medicine and devices.

FDA Warning Letters
FDA posts warning letters on their web site; they can be searched by company, subject, date, issuing office, or regulation citation, and are great training tools.

FDA Frequently Requested 483s
FDA posts frequently requested 483s or inspectional observations on their web site. Most are for GMP issues; however, several concern GLP and GCP violations.

FDA Enforcement Report

Issued twice a month, this publication contains information on recent recalls reported to, and classified by, FDA.

FDA Investigations Operations Manual (IOM)
This is FDA's primary document on inspection policy and procedures for FDA investigators. It covers sampling, inspections, investigations, regulatory actions and recall activities.

Copyright 2007, Immel Resources LLC, Petaluma, CA USA, (707) 778-7222, www.immel.com, immel@immel.com

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