EAS Consulting Group, LLC — EAS-e-NEWS — Current FDA Issues of Interest
A free monthly electronic newsletter published by EAS Consulting Group, LLC for the industries regulated by FDA.
Pharmaceuticals · Medical Devices · Foods · Dietary Supplements · Cosmetics · Tobacco Products
EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
 August 2010
In this Issue
Upcoming EAS Events
  • Binzhou International Sustainable and Economic Development Conference [more]
  • Food Forum USA [more]
  • Dietary Supplement GMP Seminar [more]
  • Supply Side West [more]
  • 2010 Regulatory Affairs Professional Society Annual Conference and Exhibition [more]
  • China International Food Safety and Quality Conference [more]
  • Dietary Supplement Labeling Compliance Review Seminar [more]

From the Desk of the President
A Friend and Colleague Rejoins FDA

Ed Steele, President

Dear Reader,

Welcome to the August issue of EAS-e-News, our monthly newsletter for industries regulated by the Food and Drug Administration. The agency has just added a new name to its senior management—our friend and colleague, Philip Derfler, who rejoined the agency from USDA August 2 as Associate Commissioner for Foods Policy in the Office of Foods.

Phil was most recently Assistant Administrator for the Office of Policy and Program Development at USDA’s Food Safety and Inspection Service. He formerly worked in FDA’s Office of General Counsel where he was the senior food lawyer working on implementation of the Nutrition Labeling and Education Act in the early 1990s. In his new position he will chair the newly established Foods Program Regulations and Policy Steering Committee comprised of senior leaders from CFSAN, CVM, ORA, the Office of Foods, the Office of Policy, and the Office of Chief Counsel. We wish him well in this challenging new role.

In other food-related news, Deputy Commissioner for Foods, Mike Taylor, issued an up-beat report on the progress of the Reportable Food Registry, describing it as “quite a success story” and “a positive new tool” in a July 28 media briefing. But he cautioned that the data set after just seven months is too small to allow the agency to detect any patterns.

In the drugs arena, meanwhile, we notice that the agency is showing more interest in compliance of electronic records and that it plans to conduct a series of inspections and to take enforcement action if necessary (see below).

Our Issue of the Month article for August reviews the Freedom of Information Act. The author is EAS Director, Regulatory Information and Submissions Chris Celeste, who is a leading expert in how to make the best use of FOI requests.

In EAS news, I was accompanied by Senior Consultants Madhu Soni and Dr. James Hoadley in manning the EAS exhibit booth at the Institute of Food Technologists annual meeting and expo in Chicago, July 17-20. I was delighted to meet many readers of EAS-e-News and was grateful for their generous reviews. This year’s IFT event drew 21,500 participants from around the world—not a bad turnout in a recession.

Notwithstanding the weak economy, we continue to be very busy at this time and our consulting team continues to grow steadily. I am pleased to welcome the newest member David Miller to our team. David brings a wealth of compliance experience from his career in the pharmaceuticals sector, most notably with Proctor & Gamble Pharmaceuticals.

As always, I hope you continue to find our updates useful and I invite you to share them with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
The Freedom of Information Act: Who Uses it and What’s Available?

By Charles “Chris” Celeste, RAC, Director, Regulatory Information and Submissions

For most of us who work with FDA regulatory matters, the Freedom of Information Act has been a fixture throughout our professional lives. But everything has a beginning, and the FOIA was enacted in 1966—mid-way through the Lyndon B. Johnson Administration—and went into effect on July 5, 1967, providing public access to information or records held by U.S. Federal Agencies.

The FOIA has undergone various amendments, in 1974, 1978, 1986, 1996, 2002, and 2007. Most recently, President Obama issued a memorandum on FOIA indicating that agencies should take steps to provide information to the public and not wait for the specific FOIA requests. The memorandum also directed the agencies to provide prompt responses.

The FOI program costs the agency more than $20 million a year. Total agency costs associated with FOI activities (processing, litigation, etc.) for fiscal year 2009 reached $21 million, but the agency recovered only $388,084 in processing fees. The agency has 124.4 full-time staff working on FOI matters, and many other employees contribute on an as-needed or as-available basis. For FY 09, FDA logged about 10,337 requests and closed the year with more than 12,000 requests still pending. The median processing time for a “simple” request was 10 days, although “complex” requests averaged 293 days.

Who uses FOI?

FOI requests are typically submitted by private individuals, industry, attorneys, the press, and consulting firms. Most FOIA requestors are trying to gain a better understanding of the agency’s policies, procedures and positions. For example a firm that requests information on a new drug application may be trying to determine the design of the clinical studies and to learn the agency’s position. Firms requesting information on establishment inspection reports, 483s, etc. may be trying to determine FDA’s current inspection trends or areas that specific FDA Investigators may be looking at during inspections. Other firms request information on their own products and material to find out what the agency is releasing about their products.

FOIA covers most routine regulatory business, but it exempts the following nine types of information from public disclosure:

  • Classified national defense and foreign relations information;
  • Internal agency rules and practices;
  • Information that is prohibited from disclosure by another federal law;
  • Trade Secrets and other confidential business information;
  • Inter-agency communications that are protected by legal privileges;
  • Information involving personal privacy;
  • Records or information compiled for law enforcement purposes;
  • Information relating to the supervision of financial institutions; and
  • Geological information on wells.

FDA’s policy and procedures for handling FOI requests are described in 21 CFR part 20. Subpart D (sections 20.61 through 20.67) describes the seven current exemptions which comprise the basis for denial decisions: trade secrets and commercial or financial information which is privileged or confidential; inter or intra-agency memoranda or letters; personal, medical and similar files; law enforcement records or information; national defense and foreign policy; internal personnel rules and practices and records exempted by other statutes.

EAS routinely uses the FOIA to obtain information on behalf of its clients. We conduct regulatory searches at the agency’s public reading rooms, monitor specific areas of interest and provide detailed findings. We conduct these activities daily, weekly, bi-weekly, monthly or on request as needed. Some of our clients have us file requests on their behalf because they want to remain anonymous. FDA provides a log of all FOI requests and competitors often monitor this log to gather information on who made requests and on what was requested.

Electronic Records

Improved access to electronic records is greatly changing the FOI program. The Electronic Freedom of Information Act Amendment of 1996 (EFOIA) required the creation of electronic reading rooms, and required agencies to provide records in an electronic format. FDA has created electronic reading rooms for the various divisions (CDER, CBER, CVM, CFSAN, ORA, etc) and the agency is posting more information online. The posts include various types of important regulatory information such as: Approval Information for New Drug Applications, Warning Letters, Adverse Drug Events and ORA’s electronic reading room even posts Establishment Inspection Reports/483s. But not every piece of information is being posted and a FOIA request may still be needed to obtain information that is not currently available on the agency’s website.

Who's Who at EAS
Meet EAS Senior Consultant John Yount

John Yount

John Yount has been a leading auditor of pharma companies since retiring from the Food and Drug Administration in 1998. He is an accomplished speaker and has provided extensive training in the pharmaceutical, food, and nutritional supplement industries. In addition, he is the author of numerous articles on FDA regulations, programs, and policies.

Mr. Yount’s final role at the federal agency was as Assistant Regional Director of the Dallas Regional Office, where he managed the Milk, Food, Shellfish, and Radiological Health programs staff, the Small Business staff, the Regional Computer Center staff, and the Regional Training office. Prior to that role, he was Director of Investigations in the Denver District office and previously served as a Supervisory Investigator and an Investigator for several years. He served as a trainer for the agency in several of their national training programs, including courses on law and evidence development for FDA investigators and chemists. He held special training credentials for clinical investigations, and had extensive experience in all FDA-regulated industries.

He is an expert in Good Clinical Practices, Good Manufacturing Practices (for finished dosage form as well as active pharmaceuticals), and Good Laboratory Procedures. And he has conducted numerous audits covering the production of sterile APIs and sterile finished dosage form drugs, vaccines and blood products.

He lived and worked in the United Kingdom for two years and has direct experience in the auditing of vaccine productions facilities in Europe. This includes audits of adenoviral vaccine intermediates for phase I, and II clinical studies, recombinant MVA (Modified Vaccine Ankara Virus) and retroviral vectors. In addition, he has direct experience in the auditing of blood fractionation. He has significant experience in conducting audits of plants producing medical gas by air separation and by chemical production.

After leaving the agency, he became a senior consultant for AAC/Kendle. He joined EAS Consulting Group in January 2010.

“John is a key member of our consulting team,” says EAS President Ed Steele. “We are very fortunate to have someone with his extensive knowledge and expertise available for our clients.”

FDA Shows Renewed Interest in Part 11 Compliance

FDA is showing renewed interest in Electronic Records and Signatures (21 CFR, Part 11) compliance for drug products. In a July 9, 2010 announcement FDA’s Center for Drug Evaluation and Research indicated that they will begin a series of inspections focused on 21 CFR, Part 11, Electronic Records; Electronic Signatures compliance. FDA will be taking the necessary enforcement actions if warranted as a result of the findings during these inspections. Their actions will be based on conditions that do not fall under the enforcement discretion as described in the August 2003 Guidance – “Part 11, Electronic Records; Electronic Signatures – Scope and Application”.

The publication of Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application dated August 2003 changed the interpretation of Electronic Record and Electronic Signatures compliance requirements. Some of these changes were received with mixed emotions. Some of these changes implied FDA’s use of enforcement discretion on certain requirements. Currently, the agency has not issued any new guidance or rules to provide clarification to industry.

EAS can assist your firm with Part 11 compliance, training, auditing and general consulting.

Reportable Food Registry Report Contains No Surprises

FDA’s report on data for the first seven months of the Reportable Food Registry lists 1,844 total entries, of which just 125 were “primary” reports, the rest being subsequent reports relating to those. A single primary report of Salmonella in hydrolyzed vegetable protein accounted for 1,001 of the total entries.

The breakdown of issues reported reflects known patterns of contamination in food products, with Salmonella accounting for 37 percent, followed by allergens (35 percent), Listeria (13 percent), other contaminants (seven percent), uneviscerated fish (three percent), E. coli O157:H7 (two percent), and foreign objects (two percent).

The agency has a “triage” process in place whereby a Risk Control Review team meets three times a week to decide what to do about each report. This team includes representatives from the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the Office of Emergency Operations and the Office of Regulatory Affairs.

The FDA District Office for the geographic area from which the report originated also takes part in the review. The RFR report avoids sensitive issues such as the burden that the program has placed on agency resources, especially on the District Offices that have to do the legwork to follow up on each report.

Former CFSAN Director Robert Brackett Joins NCFST

Robert Brackett

Robert Brackett, former director of FDA’s Center for Food Safety and Applied Nutrition, has joined the National Center for Food Safety and Technology at Illinois Institute of Technology’s Moffett Campus in Chicago, where he is now the director and vice president.

He was most recently the senior vice president and chief science and regulatory officer for the Grocery Manufacturers Association, a position he held since 2007.

From 1994 until 2000, he served as Professor of Food Science and Technology in the Center for Food Safety at the University of Georgia, where he was an active researcher in the area of food microbiology. He has also served on the faculty of North Carolina State University, as Extension Food Safety Specialist and Assistant Professor. He received his B.S. in bacteriology and his M.S. and Ph.D. in food microbiology, all from the University of Wisconsin-Madison.

What's New on FDA's Website
July Updates

Listed below are links to new additions to the FDA website for the month of July, 2010. Use of this section of EAS-e-News is intended to provide an "easy" way to keep current with FDA news and information.

FDA Press Announcements
Recalls and Safety Alerts
Congressional Testimony
Enforcement Reports
What's New by Topic

EAS in Action

EAS Welcomes New Senior Consultant

David S. Miller

In his 30-year career in the pharma sector, David S. Miller has acquired advanced expertise as a compliance auditor, trainer and developer of quality assurance policies and procedures for multinational pharmaceutical companies.

Most recently, he was global compliance auditor at Warner Chilcott Pharmaceuticals, which acquired Procter & Gamble Pharmaceuticals in October 2009.

Mr. Miller joined P&GP North America in 1982 as a compliance auditor, and advanced to become global compliance auditor in late 1995. From December 2001 to October 2009, he was P&GP’s principal scientist and compliance specialist. In this role, he conducted compliance audits at P&GP plants as well as those of contract manufacturers and API suppliers in North America, Europe, and Asia.

He is a recognized expert in solid oral, biological, and aseptic product manufacturing. In addition, his work has included the development of validation training programs, as well as pre-approval inspections, corrective action audits, and licensing and acquisition, among other QA-related activities.

“I am delighted to welcome David to our consulting team,” says EAS President Ed Steele. “Our pharma clients now have access to his extensive knowledge to fulfill their compliance and training needs.”

2010 IFT Expo Was “Best Ever”

IFT annual meeting and expo

The Institute of Food Technologists 2010 annual meeting and expo, held in Chicago, July 17-20, was the best ever in terms of traffic to the EAS exhibit booth, according to EAS President Ed Steele.

“Of all the trade shows I have been to, the traffic past our booth at this IFT event was the greatest I have ever seen,” Steele says. He believes the increase in traffic correlates with the heightened interest in food safety.

The event drew an estimated 21,500 food scientists, suppliers, marketers, and others from around the world. The technical portion of the meeting including more than 1,000 presentations covering topics ranging from new health and safety benefits and product innovations to the latest consumer favorites, fears, and trends.

Congratulations to Maria Hernandez, Abbott Laboratories, winner of the free iPod Nano drawing for participants who left their business cards at the EAS booth.

The next IFT annual meeting and expo will be held in New Orleans.

EAS-e-Docs
Latest Additions to the EAS-e-Docs Service

EAS-e-Docs

Here are the most recent additions to our new EAS-e-Docs service, which provides easy access to selected documents that we believe will help industry in complying with FDA’s laws and regulations:

Foods:

A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration: The Reportable Food Registry. This report presents FDA’s experience with the Reportable Food Registry (RFR) from the opening of the Reportable Food electronic portal on September 8, 2009, until March 31, 2010.

Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON) in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed. In response to a May 14, 2010 letter to Dr. Bernadette Dunham, Director, Center for Veterinary Medicine (CVM), from the National Grain and Feed Association and American Feed Industry Association, CVM conducted a review of the recent scientific literature and determined that the 1993 advisory levels for DON in grains and grain by products destined for cattle can be revised. Recent studies demonstrate that higher levels of DON in feed for cattle would not appear to present an animal or public health hazard.

Drugs:

ICH; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter. This draft guidance provides the results of the ICH Q4B evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. It is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region.

ICH; Draft Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonization Regions; Annex 14 on Bacterial Endotoxins Test General Chapter. The draft guidance provides the results of the ICH Q4B evaluation of the Bacterial Endotoxins Test General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. It is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region.

ICH; Draft Recommendation for the Revision of the Permitted Daily Exposure for the Solvent Cumene According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents. This draft recommendation is for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ‘‘Q3C: Impurities: Residual Solvents.’’ The draft recommendation was prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Medical Devices:

Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers. This guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for HDEs.

Tobacco:

Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs. This draft guidance document is intended to assist tobacco retailers who wish to implement effective training programs for employees.

A free copy of these and other valuable documents will be sent to you by email upon request from the EAS-e-Docs page of the EAS website. Click here for a full list of available documents.

Upcoming Events

Dietary Supplement GMP Seminar

EAS will hold a dietary supplement GMP seminar September 14-15, 2010 at the EAS training facility in Alexandria, Va, to explain compliance requirements of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements. Visit the EAS web site for more details.

Learn How to Comply With Dietary Supplement Labeling Regulations

EAS has scheduled a Dietary Supplement Labeling Seminar at the EAS training facility in Alexandria, Va, November 16-17, 2010, at which participants will learn how to prepare supplement labels that comply with FDA requirements. This seminar is designed for individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of dietary supplements, including those responsible for preparing or reviewing labels. Participants get an opportunity to apply learning in practical work sessions to facilitate their understanding of the regulations. They also receive the popular hardback labeling reference, Dietary Supplement Labeling Compliance Review, authored by EAS Senior Consultant, James Summers with contributions by EAS Vice President, Elizabeth “Betty” Campbell. Visit the EAS web site for more details.

Upcoming Events

Binzhou International Sustainable and Economic Development Conference
August 25-27, 2010
Binzhou, Shandong Province, China
Presenter: Douglas Nelson
(Contact EAS for details)

Food Forum USA
September 2, 2010
Hannover, Germany
Presenter: Gisela Leon
(Contact EAS for details)

Dietary Supplement GMP Seminar:
Sept. 14-15, 2010
EAS Headquarters
Alexandria, Va.
(Contact EAS for details).

Supply Side West
October 19-23, 2010
Las Vegas, Nev.
Booth 24120

2010 Regulatory Affairs Professional Society Annual Conference and Exhibition
October 24-27, 2010
San Jose, Calif.
Booth 435

China International Food Safety and Quality Conference
November 10-11, 2010
Shanghai, China
(Contact EAS for details)

Dietary Supplement Labeling Compliance Review Seminar
November 16, 2010
EAS Headquarters
Alexandria, Va.
(Contact EAS for details).

Order Publications and Regulatory Tools

EAS Labeling Type Size Guide EAS Labeling Type Size Guide

A handy tool for measuring type size, package dimensions and line width on food, dietary supplement, cosmetic and OTC drug labels.		 $ 9.00
Code of Federal Regulations, A pocket Guide

Dietary Supplement GMP Regulation -
A Pocket Guide

A 4"x6" bound copy of 21 CFR Part 111 designed to fit in shirt pockets of management and plant personnel.

 < 25 $ 10.00 each
25-50 $ 9.00 each
50-100 $ 8.00 each
> 100 $ 7.00 each
Dietary Supplement Labeling Compliance Review, 3rd edition Dietary Supplement Labeling Compliance Review, 3rd edition

A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell

Hardbound book		 $ 194.99
Food Labeling Compliance Review, 4th edition Food Labeling Compliance Review, 4th edition

A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell.

Hardbound book and CD		 $ 229.00 / set
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