FDA, industry workshops to inform on drug quality systems

Industry has three opportunities this summer to learn about the Agency's progress on its pharmaceutical current Good Manufacturing Practices (cGMPs) initiative (See August 30, 2002, XNL, and February 21 XNL) in the form of the FDA/Industry Summer Workshop series. The series will take place in three different, convenient locations. In June, the workshop will be in New Jersey. In July, it moves to Puerto Rico. The final workshop will take place in Illinois in August. 

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FDA/Industry Summer Workshops

June 16, 2003
Sheraton Meadowlands Hotel
East Rutherford, New Jersey

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July 14, 2003
San Juan Marriott Resort
San Juan, Puerto Rico

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August 12, 2003
Hyatt Regency Chicago
Chicago, Illinois

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These sessions are designed to bring both pharmaceutical professionals and FDA officials from the field together to exchange views. With FDA's evolving risk-based approach to GMPs, such face-to-face educational opportunities can provide invaluable instruction to industry to improve compliance with regulations. The workshops will explain various aspects of the Agency's cGMP initiative, including:

• FDA's current thinking and goals,

• Industry's perceptions,

• Drivers for change,

• Costs and compliance implications,

• Obstacles, and 

• Industry's and FDA's experiences in quality systems.

Other associations sponsoring the workshops in addition to CHPA include the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association, and the International Pharmaceutical Excipients Council of the Americas.

More information is available on CHPA's web site. 

CHPA contact: Fred Razzaghi

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Detailed information and registration materials can be found in the Members Only section of CHPA's web site.

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CHPA educates FDA on the challenges of label changes

CHPA’s Scientific Affairs Committee and the Agency sponsored a joint educational seminar for FDAers May 15 to explain the overall process and challenges of designing, obtaining, and implementing labels for OTC products. Association member company personnel, specifically specialists in regulatory affairs and packaging, educated FDA participants on:

• OTC label components;
• FDA and non-Agency requirements of the label and their purpose;
• The processes industry goes through to either create or make a change to OTC labels; and 
• The challenges of making labeling changes, such as those involving timing to market, inventory management, physical limitations, and retailer requirements. 

More than 100 FDAers attended the seminar. A joint CHPA/FDA steering committee is currently working on future seminars to exchange information on other topics related to the regulation of OTC drug products. 

CHPA contact: Dr. Lorna Totman

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Industry coalition files comments on various Part 11 issues 

With other Industry Coalition on 21 CFR Part 11 members, CHPA filed comments April 28 supporting the risk-based approach taken in the FDA draft guidance on the scope and application of the electronic records and signatures rule. However, the comments reminded the Agency that “integrating risk-based processes into Part 11 computer system validation, audit trails, and electronic data retention will take time and this reality should be clearly recognized in FDA’s plans for future guidance, enforcement, and internal training.”

The coalition also echoed its support of ongoing dialogue to address critical issues to ensure effective compliance. One critical issue highlighted in the April 28 comments was computer validation. Developed by FDA’s Center for Devices and Radiological Health, the guidance on this subject “is a sound document” according to the coalition. The second critical area involves the Agency’s Compliance Policy Guide. The coalition praised FDA for withdrawing the guide, opting instead to exercise discretion prior to taking regulatory action. In its comments, the coalition suggested that the Agency “make an effort to work with the field inspectors to explain how this [discretion] will be conceptually applied in practice.” 

The coalition—members of which include the various trade associations representing manufacturers of FDA-regulated products, including CHPA—pledged to continue to work with the Agency on future guidances. 

CHPA contact: Fred Razzaghi

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FDA issues second set of food safety regs

The Agency proposed May 9 the last set of food safety regulations required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The two proposed regulations were announced in a May 6 press release and cover establishing and maintaining records among food firms and administrative detention of foods, including dietary supplements, that may pose a risk to the public. The first set of proposed regulations—registration of food facilities and prior notice—were published earlier this year (See February 7 XNL). CHPA commented on both the registration and prior notice proposals April 4. 

The recently issued proposal regarding record keeping is designed to let FDA track foods implicated in emergencies. The rule would require manufacturers, processors, packers, distributors, receivers, holders, and importers of foods to record the immediate source and subsequent receiver of any food. Companies can keep these records in any form—paper or electronic—they prefer, provided their records are complete. FDA plans to publish a final rule on the subject by December 12. 

The proposal regarding administrative detention covers aspects of FDA's authority to detain any food that poses a credible threat to public health. The proposal outlines the Agency procedures for executing expedited enforcement actions against perishable foods, how FDA will detain foods, and the process for appealing a detention order. 

The Agency invites stakeholders to comment electronically on these proposals by July 8. 

CHPA contact: Steve Mister

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ODS plans for the future

The National Institutes of Health’s Office of Dietary Supplements (ODS) held a strategic planning session May 8-9 in Bethesda, Maryland, to review the progress it has made in the past five years and to look forward to the coming five years. CHPA attended the meeting with others from industry, academia, and various governmental agencies. 

ODS received favorable reviews of its accomplishments over the past five years during the session, especially in the key program area of developing and communicating information about dietary supplements. Other goals in the office’s original 1998-2003 strategic plan were:

1. Evaluation of the role of dietary supplements in disease prevention and risk reduction, 
2. Examination of the role dietary supplements play in physical and mental health and performance, 
3. Exploration of dietary supplements’ biochemical and cellular effects, and 
4. Improvement of scientific methodology. 

ODS’s original goals were deemed appropriate for the 2004-2009 strategic plan by attendees. They, however, did call for more emphasis on new methodologies to look at wellness endpoints and a continued focus on determining strength, purity, and standards for botanicals. ODS was urged to become the organization that FDA and other governmental agencies seek for advice in this area and to include in its goals coordination among user groups. Another recommendation was to add dietary supplement safety explicitly to the ODS goals.

ODS is accepting additional comments through at least June 27 on its goals for 2004-2009 at ODSPlan@od.nih.gov. Comments will be synthesized and a revised version will be crafted with input from a steering committee. A draft version of the 2004-2009 goals should be publicly available in the fall, with final publication anticipated by year’s end. 

CHPA contacts: Dr. Doug Bierer and Dr. Lorna Totman

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FDA extends the comment deadline for dietary supplement GMPs 

The Agency provided advance notice May 16 that it intends to extend the comment period on the proposed rule for dietary supplement Good Manufacturing Practices (GMPs). The Federal Register notice that will officially announce the new comment deadline of August 11 is scheduled for publication May 19. 

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Reauthorization of the National Youth Anti-Drug Media Campaign moves forward

On May 15, the House Government Reform Subcommittee on Criminal Justice, Drug Policy, and Human Resources passed HR 2086, the Office of National Drug Control Policy Reauthorization Act of 2003, which includes the reauthorization of the National Youth Anti-Drug Media Campaign for the next five years. The bill now heads to the full committee where it is expected to be addressed in the next few weeks. HR 2086 has also been referred to the House Judiciary, Energy and Commerce, and Intelligence committees.  

While supportive of the National Youth Anti-Drug Media Campaign (See April 18 XNL), CHPA has concerns with the campaign strategy development process outlined in the bill, and will be working with staff in both the House and Senate to amend this section of the bill.

CHPA contacts: Kevin Kraushaar and Amber Thyson

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FDA rules sodium sulfide 1 percent GRAS/E

FDA reversed its previous decision on sodium sulfide 1 percent in a gel vehicle by ruling the active ingredient is generally recognized as safe and effective (GRAS/E) for OTC ingrown toenail relief. This decision reverses a 1993 final rule and removes the ingredient from the list of nonmonograph OTC active ingredients for ingrown toenail relief. The May 7 final rule notes that such products are used with retainer rings to keep the product in the application area. The rule is effective June 6. 

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Agency publishes "Photosafety Testing" guidance

FDA announced May 7 the availability of a guidance for industry on when to test for photoirritation and assess the potential of both topical and systemic drugs to cause certain skin cancers. The document stresses a science-based approach that seeks to ensure appropriate assessment of photosafety while reducing unnecessary testing. 

CHPA contact: Dr. Lorna Totman

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NCTR Science Advisory Board will meet

The May 9 Federal Register announced the Science Advisory Board of the National Center for Toxicological Research will meet June 19-20. Among the subjects that will be discussed is the formation of a Pharmaceutical Safety Working Group. A portion of the meeting, which will take place in Jefferson, Arkansas, will be closed to the public. Up-to-date information is available on the FDA Advisory Committee Information Line at 1 (800) 741-8138, code 12559.  

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HHS launches health web sites for Asian-Pacific Americans

In recognition of Asian-Pacific American Heritage Month, U.S. Department of Health and Human Services (HHS) Secretary Tommy G. Thompson announced the creation of two web sites specifically designed for this audience. 

Healthfinder® now features a special consumer-oriented section for Asian Americans, native Hawaiians, and other Pacific Islanders. The section is located at http://www.healthfinder.gov/justforyou/, and is the third special population healthfinder® section developed. 

Asian American Health is a new web site of the National Institutes of Health's National Library of Medicine. It features census data on major Asian American populations, as well as cultural information, links to health policy offices, online medical databases, and publications. 

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Japan association changes name, leadership 

At its general meeting May 7, the Proprietary Association of Japan made a number of major announcements, including a name change to, in the English language, the Japan Self-Medication Industry (JSMI). 

JSMI also announced that Shinji Nitta was retiring as president of the association and would assume the position of honorary adviser to the group. Nitta had a long and distinguished tenure with the association, serving as its president since 1985. Previously, he held a number of senior positions in Japan’s Ministry of Health, Labour, and Welfare. A search for a successor is ongoing.

JSMI also elected an incoming chairman at the meeting. Sachiaki Ibe, president, Zeria Pharmaceutical Co., Ltd., was named to the post. 

CHPA contact: David Spangler

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CHPA staff travel inside the Beltway and beyond

CHPA President Linda Suydam received FDA's Commissioner’s Special Citation award May 9 for her work as a member of the User Fee Legislative Team during her tenure at the Agency. Commissioner Mark McClellan presented the award at the FDA Honor Awards Ceremony. The group was chosen “for exemplary performance and teamwork leading to the successful passage of the Prescription Drug and Medical Device User Fee Acts of 2002”....  

Staff from CHPA's Government Relations department participated in the John Chafee Awards Dinner May 14. The department's vice president, Kevin Kraushaar, and associate, Amber Thyson, attended the D.C. event, which was sponsored by the Republican Main Street Partnership. The featured speaker and guest of honor was White House Chief of Staff Andrew Card. Several members of Congress attended the event, as did Maryland Governor Bob Ehrlich...

CHPA staff was out in force May 14 to show support for the Campaign for Tobacco Free Kids. CHPA's president and staff attended the 2003 Youth Advocates of the Year Awards Gala in Washington, D.C., to honor young activists against tobacco addiction and related diseases. Honorees received scholarships and grants...

On May 8, CHPA Vice President-International and Assistant General Counsel Dave Spangler visited with incoming World Self-Medication Industry (WSMI) chairman Gary Balkema from Bayer HealthCare LLC to discuss WSMI's priorities. Balkema will take the reigns of WSMI at the federation's June 3 board meeting in Cannes, France...

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DIA readies for its 39th annual meeting

The Drug Information Association (DIA) is putting the finishing touches on the agenda for its 39th annual meeting. Scheduled for June 15-19 in San Antonio, Texas, the meeting will feature over 350 sessions on various interest areas, including clinical safety and pharmacovigilance, good clinical practices, public policy and law, and regulatory affairs. FDA Senior Associate Commissioner Murray M. Lumpkin, M.D., serves as the meeting chairperson. For more information or to register online, visit DIA's web site. 

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AAPS will explore advances in pharmaceutical processing

The American Association of Pharmaceutical Scientists (AAPS) will host a meeting June 19-20 to focus on process analytical technologies, or PAT, and other issues of importance to the industry. Through lectures and exhibits, experts in the field will provide attendees with perspectives on PAT, updates on excipient functionality and harmonization, and more. Visit AAPS online for detailed information on this New Jersey conference.

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FDA/Industry Summer Workshop
June 16, 2003
Sheraton Meadowlands
East Rutherford, New Jersey

FDA/Industry Summer Workshop
July 14, 2003
San Juan Marriott Resort & Stellaris Casino
San Juan, Puerto Rico

FDA/Industry Summer Workshop
August 12, 2003
Hyatt Regency Chicago
Chicago, Illinois

CHPA MarketPlace 2003: The First CHPA Business Exchange
September 18, 2003
Hilton East Brunswick
13 Tower Center Blvd.
East Brunswick, New Jersey

Manufacturing Controls Seminar
October 9-10, 2003
Hilton Parsippany Hotel
One Hilton Court
Parsippany, New Jersey

Regulatory and Scientific Conference
November 6-7, 2003
The Fairmont Washington
2401 M Street, NW
Washington, D.C.

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