CHPA and FDA are on the same page with dietary supplement GMPs

CHPA submitted comments to FDA's Center for Food Safety and Applied Nutrition (CFSAN) August 9 requesting that the Agency "commit to the finalization of Good Manufacturing Practices (GMPs) for dietary supplements as one of its highest priorities for fiscal year 2005." The Association issued this recommendation in response to CFSAN's June 24 request for input to help shape the center's 2005 workplan (See July 2 XNL).

In its comments, CHPA reiterated its long-time support for dietary supplement GMPs and asked that priority be given to the promulgation of a final rule by the end of 2004. The Association further stated that "effective GMP regulations are consistent with the industry's objectives of providing quality products through quality systems and quality assurance."

CHPA's submission to CFSAN came on the heels of an FDA announcement in which the Agency's Acting Commissioner Lester M. Crawford, D.V.M., Ph.D., outlined FDA's priorities for the next six months. In an August 2 FDA news release, Crawford included GMPs for both dietary supplements and drugs as two of the Agency's "important anticipated major actions." 

In the area of dietary supplements, Crawford indicated in the news release that FDA is "planning to finalize the first GMP guidance for dietary supplement manufacturers by this coming winter." With respect to drugs, Crawford said that the current GMP project launched two years ago (See August 30, 2002, XNL) will be completed by this fall.

CHPA contact: Dr. Doug Bierer

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MCS offers interaction with regulators

The Manufacturing Controls Seminar (MCS), scheduled for September 30 to October 1 in Parsippany, New Jersey, offers an excellent opportunity for attendees to interact with FDA's senior management officials on regulatory, scientific, technical, and compliance matters. The Agency's Northeast regional director, New Jersey District director, and the Washington, D.C., associate commissioner for regulatory affairs, will all be on hand and accessible to attendees.

In addition, CHPA's Manufacturing Controls Committee (MCC) is developing an information-loaded program focusing on the major issues of importance to the industry. Some of the highlights of the MCS will include:

• A workshop on a process risk assessment procedure applicable to a variety of internal processes.
• Two workshops under the manufacturing science heading that will focus on process analytical technology and lean manufacturing.
• A workshop on the European Union directives and rules governing pharmaceutical manufacturing.
• The latest developments on CFR Part 11 and how it relates to the Good Manufacturing Practices initiative.
• The United States Pharmacopeial Convention, Inc., will present its proposed compendial acquisition campaign for attendees' input.
• The MCC's stability working group will present an alternative approach to product stability by applying a science-based approach.

The goal of the MCC is to develop a meaningful and educational MCS program that will provide industry directors and senior management with solutions for day-to-day problems. CHPA members should plan to attend and watch for other highlights of the MCS in upcoming issues of the XNL.

Register now to ensure your place at the 2004 MCS. A registration form is available in the Meetings section of www.chpa-info.org. Program materials will be made available shortly. Individuals planning to attend the MCS should contact the Hilton Parsippany directly at (877) 671-5746 and mention the CHPA room block.

CHPA contact: Fred Razzaghi

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Has your company registered for Market Exchange?

September is almost upon us, which means that the 2004 CHPA Market Exchange is coming up fast. Active members who plan to attend are encouraged to register before the August 18 deadline in order to be included in the printed registration book. Individuals handling appointment scheduling for their companies should check the updated attendance list in the Members Only section of www.chpa-info.org daily to ensure the most accurate listing of companies participating.

_______________________

CHPA 2004 Market Exchange
September 23
Hilton East Brunswick
East Brunswick, New Jersey
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All table hosts have received guidelines concerning their companies' participation in Market Exchange. CHPA must receive the company description form that was enclosed with the guidelines by August 18 for the information to be included in the printed registration book.

Members may either register for Market Exchange online or download the form and fax it to CHPA. Either option is available in the Members Only section of CHPA's web site. E-mail CHPA's Susan DiBartolo if you do not have a password for this secured area.

Sponsorships are still available for the 2004 CHPA Market Exchange. Interested companies should contact Ted Peterson or Phyllis Taylor for more information.

CHPA contacts: Ted Peterson and Phyllis Taylor

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New online resource provides parents with information about teen health risks

CHPA and NWHRC work together to keep kids safe and healthy

The National Women's Health Resource Center (NWHRC) launched a comprehensive Internet resource August 2 that arms parents with valuable information on how to keep teens safe and healthy. The Back-to-School Teen Health Kit for Parents, made possible with funding from CHPA, provides a checklist for parents about the warning signs of depression and eating disorders, as well as tips to encourage teens to eat a balanced diet and get plenty of exercise, and make the most of their annual visit to a healthcare professional.

"Just because they're no longer toddlers, parents shouldn't think that 'wellness visits' to healthcare professionals are no longer necessary," said NWHRC President and CEO Amy Niles. "In fact, teen health check-ups are an important way for parents and teens to learn about a variety of teen health issues, such as depression, obesity, drug abuse, and smoking, as well as learn when preventive health screenings, such as blood pressure and cholesterol testing should occur."

Parents also will appreciate the "New Trends in Teen Drug Abuse" section that discusses experimentation with and abuse of illicit drugs such as alcohol, ecstasy (MDMA), and methamphetamine; prescription pain relievers; inhalants; and OTC cough medicines containing dextromethorphan. An important component of the kit is "How to Raise Healthy, Drug-Free Teens," a frank and informative question-and-answer article highlighting the views of leading experts in adolescent medicine.

"Parenting has never been more challenging," said CHPA President Linda A. Suydam, D.P.A. "That is why this comprehensive material from NWHRC is so valuable, especially now as kids are starting a new school year full of new activities and friends. The 'Back-to-School' kit helps parents navigate the at-times precarious terrain of providing guidance to teenagers, from recognizing eating disorders and medication abuse to encouraging positive behaviors and academic performance."

The Back-to-School Teen Health Kit for Parents can be found at www.healthywomen.org.

CHPA contact: Mimi Pappas

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Howard joins CHPA's Regulatory and Scientific Affairs Department

CHPA recently announced the addition of Marcia D. Howard, Ph.D., to the Association's scientific staff. Howard assumes the lead on CHPA's scientific and regulatory efforts on nutritional supplement issues.

"We are so pleased to have a person with Marcia's expertise join our incomparable science team," said CHPA President Linda A. Suydam, D.P.A. "She will be a valuable resource to our members and staff, especially now as the Association works more closely with FDA to advance its Center for Food Safety and Applied Nutrition's program priorities."

In her role as associate director of scientific affairs, Howard will be the principal staff executive on nutritional supplements. In addition, she will play a critical part in the planning and coordination of the Association's annual Regulatory and Scientific Conference, scheduled for May 5-6, 2005 (See July 30 XNL). Howard also will assist other CHPA scientists on OTC medicine topics and actively participate in the CHPA Educational Foundation's work to better understand consumer behavior with respect to the safe use of OTC medicines and nutritional supplements.

Howard comes to CHPA from the Department of Physiological Sciences at the Oklahoma State University College of Veterinary Medicine. Prior to that, she served as a graduate assistant at the School of Pharmacy at the University of Louisiana at Monroe; a claim representative and underwriter at State Farm Insurance Company; and a research technician at the Frederick Cancer Research Facility at Program Resources, Incorporated.

Howard has degrees in biochemistry and pharmaceutical sciences. She is a student member of the Society of Toxicology, as well as a member of the International Neurotoxicology Association and the Southern Regional Educational Board Chapter of the Compact for Faculty Diversity.

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Meth Watch debuts at CADCA workshop

CHPA participated in the Community Anti-Drug Coalitions Association's (CADCA's) third annual mid-year training institute, which took place August 2-5 in Chicago, Illinois. The workshop was designed for community leaders, drug prevention personnel, and education professionals interested in making strides in reducing drug abuse through local initiatives.

CADCA Chairman and CEO Major General Arthur T. Dean opened the conference highlighting many of the efforts to combat drug abuse, including the national Meth Watch program. CHPA was one of four invited exhibitors at the conference and received overwhelming interest in the Meth Watch program from prevention advocates throughout the nation. Over 400 CADCA members were on hand to learn more about how to coordinate with Meth Watch organizers in their states.

Meth Watch programs currently are underway in Indiana, Kansas, North Dakota, Oregon, South Dakota, Tennessee, and Washington. The following states participated in CHPA's leadership training in July and are in the process of starting Meth Watch programs: Alabama, Arizona, California, Georgia, Illinois, Iowa, Michigan, Minnesota, Missouri, Montana, North Carolina, Pennsylvania, South Carolina, Texas, Utah, and Virginia.

CHPA contacts: Elizabeth Assey and Virginia Cox

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DEA proposes heightened storage security for pseudoephedrine, ephedrine

Manufacturers and distributors would be required to store pseudoephedrine and ephedrine ingredients and finished products in a secure safe or steel cabinet, cage, or room and to install a monitored alarm system, under a rule proposed by Drug Enforcement Administration (DEA). According to the notice published in the July 30 Federal Register, importers and exporters also would be affected, but retailers would not.

Safes or steel cabinets would need alarm systems that signal police or a security protection company on a 24-hour basis in the event of an attempted unauthorized entry. The alarm system would be required only if more than one kilo of pseduoephedrine or ephedrine, combined, were stored at any one time.

DEA says the new security measures are needed because it "has noted an increase in the number of thefts from distributors and manufacturers." DEA adds that the "medium level" security procedures are similar to those now used by registrants handling Schedule III through V controlled substances.

Comments on the proposed rule are due October 28.

CHPA contact: Kevin Kraushaar

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FDA seeks to amend OTC nasal decongestant monograph

FDA issued a proposed rule in the August 2 Federal Register that would amend the final monograph for OTC nasal decongestant products. As proposed, the rule would remove from product labeling the indication "for the temporary relief of nasal congestion associated with sinusitis." It also would prohibit the use of the terms "sinusitis" and "associated with sinusitis" elsewhere on the label. According to the Agency, it is concerned that the use of the sinusitis indication or related terms on product labeling may mislead consumers into thinking that oral and topical OTC nasal decongestants can be used for self-treating sinusitis, thereby delaying proper medical diagnosis and subsequent treatment.

The Agency proposes the following compliance dates for nasal decongestant products marketed under the OTC monograph:

• Twenty-four months after the publication of a final rule for products with annual sales less than $25,000, and
• Eighteen months after the publication of a final rule for all other such drug products.

Comments on the proposed rule are due by November 1.

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

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Comments on glucosamine and chondroitin are no longer needed

FDA issued a notice in the August 5 Federal Register withdrawing an earlier notice published in the June 3 Federal Register in which the Agency sought comments on a collection of information. The collection, entitled "Experimental Study of Petitioned Health Claims on Glucosamine and Chondroitin Sulfate," was submitted by FDA to the Office of Management and Budget (OMB) for emergency processing. According to FDA, the Agency is withdrawing the June 3 notice because it contained a number of errors. Additionally, FDA is withdrawing the request for OMB approval of the proposed collection of information because the Agency is currently reevaluating the overall design and objective of the study.

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FDA releases drug user fees for FY 2005

FDA published a notice in the August 2 Federal Register that establishes prescription drug user fee rates for fiscal year (FY) 2005. Base revenue amounts for application fees, establishment fees, and product fees for FY 2005 are determined by the Prescription Drug User Fee Amendments of 2002. However, the statute states that FDA should adjust those rates annually for inflation and workload.

The drug user fee rates for FY 2005 are as follows:

• Application fees—$672,000 for an application requiring clinical data or $336,000 for an application that does not require clinical data or a supplement requiring clinical data
• Establishment fees—$262,000
• Product fees—$41,710

The fees are effective October 1 through September 30, 2005. Invoices for establishment and product fees for FY 2005 will be issued by FDA in August.

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U.S. government should stay the course on Codex, says CHPA

In an August 9 letter to FDA, CHPA encouraged the U.S. government to stay the course on its position taken in the Codex vitamin and mineral supplement draft guidelines. The Association applauded the government for its strong role in getting the draft to step five of the eight-step process. CHPA noted that it believes the United States will continue to be instrumental in seeing the guidelines move through the approval process of the Codex Committee on Nutrition and Foods for Special Dietary Uses.

Regarding the content of the guidelines, CHPA said that it is critical for the draft to continue to appropriately stress that any maximum levels of vitamins and minerals be based on safety assessments and not on the arbitrary application of a percentage of recommended daily intake. The Association also stated that the draft guidelines should continue to reflect the importance of consumer choice and access to safe vitamin and mineral supplements that are labeled in a truthful and non-misleading manner.

CHPA contact: David Spangler

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CHPA staff travel inside the Beltway and beyond

CHPA's Director of Communications and Media Relations Elizabeth Assey traveled to Chicago, Illinois, August 2-5, to attend the Community Anti-Drug Coalitions Association's (CADCA's) third annual mid-year training institute. CHPA staff hosted an exhibition booth at the event in order to share details of the national Meth Watch program (See related story)...

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NBJ offers web seminar on the dietary supplement marketplace

The Nutrition Business Journal (NBJ) is hosting an online seminar to feature its annual report on the nutrition industry, with a special emphasis on the 2004 dietary supplement market, which NBJ defines as vitamins, minerals, herbs, botanicals, specialty supplements, sports nutrition, and meal replacements. The virtual conference will be held September 9 from 7:00 - 8:30 a.m. (EDT). Data presented will include market definition and research methodology, consumer sales and growth for each product subcategory, product sales breakdowns and growth by distribution channel, and listings and market shares of leading manufacturers. For more information, visit NBJ's web site.

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University of Florida research center investigates food-drug interactions

A new research center, established by the University of Florida's College of Pharmacy and the Tufts University School of Medicine, has brought together researchers in pharmacy, medicine, and food science, with the purpose of investigating known food-drug interactions and to anticipate new ones. The staff of the Center for Food-Drug Interaction Research and Education first will focus on grapefruit juice and how it affects the body's ability to break down certain drugs. The goal of the center is to increase awareness within the consumer population as well as the healthcare community. For additional details on the center, click here.

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Temple University to hold open house on M.S. program

Temple University's School of Pharmacy is hosting an open house on its training program in FDA regulatory requirements, quality principles, clinical practices, drug regulation, and research and development through its Master of Science (M.S.) degree and certificate programs in quality assurance and regulatory affairs. The program, established in 1968, continues to produce management leaders in the pharmaceutical, biotech, healthcare, chemical, and industrial sectors. The open house will be held August 25 from 5:30 to 7:30 p.m. in Fort Washington, Pennsylvania. For more information on this event, visit www.temple.edu/pharmacy_qara/ or e-mail qara@temple.edu.

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CHPA Market Exchange
September 23, 2004
Hilton East Brunswick
East Brunswick, NJ

Manufacturing Controls Seminar
September 30-October 1, 2004
Hilton Parsippany
Parsippany, NJ

Business Development Conference
November 3-4, 2004
The Westin
Providence, RI

2005 CHPA Annual Executive Conference
March 10-12, 2005
Fairmont Turnberry Isle Resort & Club
Aventura, FL

2005 Regulatory & Scientific Conference
May 5-6, 2005
Mandarin Oriental Hotel
Washington, DC

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