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
EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
 January 2010
In this Issue:
Upcoming EAS Events
  • FDLI Hot Topics Conference Session: FDA Enforcement of New Dietary Supplement GMPs [more]

From the Desk of the President:
Looking Forward to a New Decade

Ed Steele, President Dear Reader,

I hope you had a peaceful New Year and that you are now energized for the challenges—and opportunities—that 2010 is sure to bring.

As we kick off the year, I would like to draw your attention to one new development that may have a significant impact on the marketing of dietary supplements. The Federal Trade Commission is becoming more active in enforcing the substantiation of dietary supplement claims. And the Commission is collaborating more closely with FDA and with the Justice Department.

According to David C. Vladeck, director of FTC's Bureau of Consumer Protection, the Commission plans to strongly enforce the requirement for "competent and reliable scientific evidence" in substantiating health claims.

"We will be looking for more precise injunctive language in future orders that will provide clearer guidance to defendants and courts alike as to the amount and type of scientific evidence that will be required in future advertising," Vladeck said, in a presentation before the Council for Responsible Nutrition's annual symposium, October 22. The Commission will also "seek orders that harmonize with laws and regulations administered by the FDA," he said.

Another FTC goal, Vladeck said, will be to address situations where a given piece of research, although it may have been conducted according to established protocols, achieved results inconsistent with the weight of scientific evidence in the relevant field. "One outlier study should not be the sole basis of support for a claim that a product will confer a benefit – particularly a health benefit," he said.

The Commission has established three working groups to share information regarding conventional foods, dietary supplements, and over-the-counter drugs. Staff from the FTC, FDA, and the Office of Consumer Litigation of the Justice Department are conducting regular telephone conferences to increase coordination for strategic planning and case selection.

EAS Consulting Group will be closely monitoring any new initiatives by the Commission that may impact companies regulated by FDA. We expect to see an increasing number of coordinated "Internet sweeps" aimed at identifying unsupported health claims.

Our January issue features an article by Dean Cirotta on the cost-effectiveness of hiring consultants. With 20-years of operational experience in the pharmaceutical industry, he has an insider's perspective on this topic. Dean is also the subject of our Who's Who at EAS section.

I am pleased to announce that EAS has opened a new office in Rockville, Md., which will serve as the contact point for our regulatory information and submission services (see details below).

As always, I hope you continue to find EAS-e-News useful and I encourage you to share its contents with your colleagues.

Sincerely,
Ed Steele Signature
Ed Steele,
President

Issue of the Month
Consulting: A Cost Effective Method of Supplementing Your Staff
By EAS Senior Consultant Dean Cirotta
As a former president and COO of a small pharmaceutical company, I often hired highly qualified consultants to perform tasks for which I did not have experienced staff or when my staff could not accomplish the goal in a reasonable timeframe while still performing their assigned duties. Now that I have joined EAS as a senior consultant, it may seem self-serving to discuss the benefits of consultants. But I assure you that my comments are accurate all the same.

By hiring consultants with the appropriate experience and skills you can realize many benefits. For example, a consultant can focus on the goal at hand, without the interruptions of daily corporate activities, and can complete the assignment in a timely fashion. In my 22 years of experience in the pharmaceutical industry, I have seen many situations in which consultants helped complete a task at a more affordable price, as an alternative to hiring a permanent senior executive with similar skills.

Tasks for which I found hiring a consultant to be efficient in both cost and time included internal audits, vendor audits, SOP writing, training sessions, CAPA identification and implementation, validation protocol writing and execution, and the preparation of regulatory submissions. Also, I found that having my staff work side-by-side with the consultants gave them an opportunity to learn a great deal and improve their skills. This type of one-on-one training can often be more effective than off-site seminars.

Many consultants have decades of FDA and/or industry experience and have had the opportunity to work with successful companies in the industry. So they have seen how tasks can be completed in many different and effective ways. Their wide experience enables consultants to provide solutions that your staff may not have considered, usually resulting in a much more efficient solution to a problem.

When budget cuts, staff reductions and growing workloads are daily challenges for every member of management, it is more critical than ever to find ways to accomplish more with less. The next time you are struggling with multiple tasks, lack of internal experience, tight timelines and staff constraints, you could consider enlisting the assistance of an experienced consultant.

Who's Who at EAS:
Meet EAS Senior Consultant Dean Cirotta

Dean Cirotta Dean Cirotta recently joined EAS Consulting Group as part of the group's expansion of services to the pharmaceuticals sector. Mr. Cirotta has 20 years of experience in a range of pharmaceuticals firms, including senior management roles with responsibility for regulatory affairs, compliance and quality assurance.

Immediately prior to joining EAS, he was president and chief operating officer of UPM Pharmaceuticals in Baltimore, Md, a subsidiary of SJ Strategic Investments, Bristol, Tenn. From March 2004 to March 2006, he was executive vice president of regulatory affairs and quality assurance for SJ Strategic Investments. His responsibilities included regulatory affairs and QA operations for the group's two wholly-owned subsidiaries, Leitner Pharmaceuticals and UPM. From March 2006 to December 2007, he was president and COO of Leitner.

Earlier in his career, from 1987 to 1993, he was a senior regulatory compliance auditor with Glaxo in Research Triangle Park, N.C. Later, he worked with Shionogi Qualicaps, and Merz Pharmaceuticals. In 1999, he joined King Pharmaceuticals as a senior director of regulatory affairs. From June 2002 to March 2004, he held senior regulatory affairs positions at the pharmaceutical division of Bausch & Lomb in Rochester, N.Y., first as vice president of U.S. regulatory affairs, then as vice president of global regulatory affairs. He led the international regulatory team responsible for U.S. approval of Zylet and Retisert, two products used to treat eye inflammation.

Mr. Cirotta has a Bachelor of Science degree in chemistry from the University of North Carolina at Greensboro and a Master's degree in business administration from the University of North Carolina at Chapel Hill.

"I am delighted to have Dean Cirotta on our team of senior consultants," says EAS President Ed Steele. "His hands-on experience with a range of different operations gives him a perspective that will be very helpful for our clients."

What's New on FDA's Website:

Listed below are links to new additions to the FDA website for the month of December, 2009. 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 Releases
Recalls and Safety Alerts
Enforcement Reports
What's New by Topic
EAS in Action:
EAS Opens Rockville Office

EAS has opened a new office at 600 Jefferson Street, Suite 310, Rockville, Md., which is the new contact point for our regulatory information and submission services. The recently-appointed EAS Director of Regulatory Information and Submissions, Charles "Chris" Celeste, is based at the Rockville office.

EAS offers a range of pharmaceutical regulatory consulting and auditing services including application management, U.S. agent services, establishment registration and product listing, and cGMP quality system and pre-approval audits of manufacturers and vendors. Other key services include:
  • DMF, IND, ANDA, NDA, and BLA submissions;
  • Review of Chemistry and Manufacturing Control submissions.
  • Conducting cGMP, GLP and GCP audits.
EAS also offers a wide range of information services, including Freedom of Information Act submissions or searches to locate documents published or released through means other than FOIA.

To see a full list of services, click here.

Mr. Celeste can be contacted by phone by dialing the Alexandria headquarters number (703) 684-4408, where the receptionist will transfer the call.

EAS Supports Fight for Air Climb


EAS is once again supporting a former colleague, Dr. William Sietsema, in a fund-raising effort for the American Lung Association. Bill, who is vice president of clinical and regulatory strategic planning at Kendle International, is co-captain of Team Kendle, which will climb the 45-floor Carew Tower in downtown Cincinnati, Ohio, on February 28. Team Kendle was the leading fund-raising team in last year's event.

Proceeds from the Fight for Air Climb—formerly known as "Climb the Carew"—will help pay for the development of new treatments and educational programs aimed at reducing the impact of respiratory illness. The association works to eradicate numerous lung diseases such as asthma, lung cancer, emphysema, chronic bronchitis, cystic fibrosis and others.

To support the team's effort, click here.

EAS Sponsors FDLI Annual Holiday and Leadership Awards Reception

Once again EAS sponsored the Food and Drug Law Institute's Annual Holiday and Leadership Awards Reception. This year's event was held at The Madison Hotel in Washington, D.C., December 15.

This annual event gave all who attended an opportunity to socialize and exchange holiday greetings. It also offered the FDLI an opportunity to announce this year's distinguished service and leadership awards. Recipients of the 2009 Distinguished Service and Leadership Awards included:
  • Donald O. Beers and Elizabeth H. Dickinson, both Associate Chief Counsels for Drugs in FDA's Office of the Chief Counsel;
  • Arthur N. Levine, Senior Counsel with the law firm of Arnold & Porter LLP; and
  • Marlene K. Tandy, M.D., who works in the law department of Johnson & Johnson, representing the DePuy and Ethicon Endo-Surgery operating companies in matters involving FDA, as well as healthcare compliance and Health Insurance Portability and Accountability Act of 1996 issues.
FDLI has issued 50 awards since the program's inception in 1993.

Participants Rate EAS In-House GMP Seminar

EAS recently conducted an in-house dietary supplement GMP seminar for a large distributor of supplements for athletes and body builders. The seminar was presented by William Ment and Robert Fish, two former FDA staffers who are now EAS senior consultants. In-house seminars offer a very cost-effective way to train relevant personnel without incurring high travel and accommodation costs. In-house training also allows a program to be tailored to a company's specific needs. Here are some of the comments we received from participants in the recent seminar:
  • "Extremely valuable and critical to the survival of our company."
  • "A ‘must experience' for all managerial staff at all dietary supplement companies."
  • "This is my second time taking this seminar and I learned a lot of new things."
  • "Mr. Fish and Mr. Ment are very knowledgeable in all areas."
Upcoming Events

FDLI Hot Topics Conference Session:
FDA Enforcement of New Dietary Supplement GMPs
January 27, 2010
Park Hyatt Washington Hotel
Washington, D.C.
Speaker: EAS Senior Consultant William Ment
Click here to register.

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		 $ 184.99
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		 $ 209.99 / set
To purchase any items listed above download our Order Form
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