Association News

CHPA teams with Tennessee governor to stop teen meth use

First state-wide meth abuse awareness campaign launched

CHPA announced the introduction of a health education campaign in Tennessee aimed at reducing drug use among teenagers while strengthening anti-drug attitudes. Tennessee Governor Phil Bredesen launched the innovative Methamphetamine Health Education Campaign March 30 at the state’s methamphetamine conference, “Methamphetamine Response: A Multi-Discipline Approach.” Bredesen signed the Meth-Free Tennessee Act into law the same day.

The Partnership for a Drug-Free America, in conjunction with CHPA, developed this two-year media initiative aimed at reducing substance abuse among adolescents by speaking about health consequences to both teens and parents. The program’s goal is to help reduce meth and club drug use among youth by encouraging anti-drug attitudes and increasing parent-youth dialogue. The campaign combines public service advertising and print education messages with a public relations effort that involves specially-trained pediatricians reaching out to parents and teens. 

“This research-based initiative will help teenagers and parents better understand the health risks posed by methamphetamine, while also encouraging parents and other caregivers to talk with their children about the potentially lethal effects of this insidious drug,” said Governor Bredesen. Prior to the press conference, over 40 state officials, including members of the governor's Meth Task Force, elected officials, and substance abuse advocates, received an in-depth briefing about the program by CHPA and the Partnership. President and CEO of the Partnership Steve Pasierb, CHPA Vice President of Communications and Strategic Initiatives Virginia Cox, and Community Anti-Drug Coalitions Across Tennessee Executive Director Pam White were on hand to explain the initiative and answer questions.

The Partnership’s Methamphetamine Health Education Campaign has been pilot-tested in St. Louis, Missouri, and Phoenix, Arizona, since June 2003 with positive results (See June 12, 2003, XNL and June 26, 2003, XNL). Tennessee, with the support of the state’s governor, serves as the first state-wide expansion of the successful program.

Tennessee was selected as one of the regions of focus based on the prevalence of methamphetamine abuse in the state. “Experience has proven that focusing exclusively on the drug cartels and small toxic labs hasn’t worked; it’s time to focus squarely on reducing the demand for this dangerous and addictive drug,” said CHPA President Linda A. Suydam, D.P.A. “The cold, hard reality is that even occasional use of these drugs can result in harm.”

“Reducing the demand for these drugs is the real challenge, and is central to this effort to educate parents and teens about the real health risks involved,” Partnership President Steve Pasierb said.

“CHPA continues its commitment to effectively addressing the methamphetamine problem in this country, and we are pleased to team with the Partnership and the state of Tennessee to fight this plague,” continued Suydam. CHPA and the Partnership will expand the program in 2005.

CHPA contacts: Virginia Cox and Elizabeth Assey | Back to the top


2005 RSC delves into consumer behavior

CHPA’s premier scientific meeting is fast approaching and promises to offer unique insights into consumer decision-making. The theme for the 2005 Regulatory and Scientific Conference (RSC) is “Choices Consumers Make: Understanding Consumer Behavior to Enhance Self-Care.” Register today online, as you don’t want to miss this important conference May 5-6 at the Mandarin Oriental hotel in Washington, D.C.

Attendees at the May RSC will get an in-depth perspective into:

• Why consumers do what they do.

• Why consumers make particular healthcare decisions.

• How a better understanding of consumer behaviors can enhance self-care.

The RSC program for the first day focuses on consumer behavior: how it is assessed and what we know.  A special feature is a keynote address by Mary Lou Quinlan, a well-known author and founder of the Just Ask a Woman strategic marketing consultancy. Quinlan will enlighten attendees about what women say and do regarding healthcare.

Other informational and useful presentations will provide an overview of various research techniques that can be used to study consumer behavior. Qualitative techniques can be used to delve into consumers’ motivations, language, habits, and lifestyles, while quantitative techniques are used to develop statistically representative samples of segments of the population. One particular qualitative technique, the Zaltman Metaphor Elicitation Technique (ZMET), will be discussed by its innovator, Gerald Zaltman, Ph.D., professor emeritus, Harvard Business School at the meeting. Other qualitative and quantitative techniques will be presented by Ray Luther, associate director, consumer market knowledge, Procter & Gamble Pharmaceuticals, and Annie Weber, senior vice president, Roper Public Affairs Division, NOP World.

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Regulatory and Scientific Conference
May 5-6, 2005
Mandarin Oriental
Washington, D.C.
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Three interactive workshops intended to increase understanding and make proposals for self-care enhancement will provide opportunities for learning and interaction among RSC attendees. The workshop topics are consumer segmentation, questionnaire development, and understanding consumer preferences and decisions related to OTC use.

The second day of the program will consolidate the learnings of the first day and identify factors that could enable better self-care. Charles J. Ganley, M.D., director, Division of Over-the-Counter Drug Products, Office of Drug Evaluation V, Center for Drug Evaluation and Research, FDA, will speak on current OTC drug issues at the Agency, including expanding appropriate OTC access. Steven L. Bodhaine, group president, Yankelovich Partners, Inc., will present late-breaking results from a large-scale study of consumer preventative healthcare behaviors. Other experts from FDA and academia will join several of the conference speakers in a panel discussion on how knowledge gained about consumer behavior could be applied to enhance self-care.

The RSC program and registration brochure is available online. Room reservations should be made directly at the Mandarin Oriental Washington at (888) 888-1778. CHPA attendees can make reservations online at www.mandarinoriental.com/washington. After clicking on “Reservations,” enter code 45105H in the “Corporate/Promotion Code” box. The cut-off date for the CHPA room block is April 13.

 CHPA thanks this year’s RSC sponsors:

CHPA contacts: Dr. Lorna Totman and Dr. Marcia Howard | Back to the top


FDA/industry summer workshops focus on cGMPs

FDA and industry hosts are offering three opportunities this summer to get the latest, most in-depth information on the evolving approach to risk management and current Good Manufacturing Practices (cGMPs) in the United States. Summer workshops, hosted by FDA, CHPA, and other trade groups, will cover some of the applications the industry is using in assessing risk as well as the quality system aspects of risk management. The subject is especially critical now that FDA has moved into the implementation phase of its quality initiative and will be reporting on progress in some of these areas.

Three sessions available!
 

June 6, 2005 Hilton Parsippany Parsippany, NJ

July 14, 2005 Hyatt Regency Chicago, IL

August 4, 2005 Sheraton Delfina Santa Monica, CA

Workshops will be held in New Jersey in June, Illinois in July, and California in August. Professionals within the operations, laboratory controls, quality assurance, supply chain, and management controls are encouraged to participate in a workshop. Investigators and compliance professionals from FDA also should pick a date and location to attend.

Program and registrations materials may be downloaded from CHPA' s web site. Online meeting registration also is available.

CHPA contact:  Fred Razzaghi |  Back to the top

CHPA on the Road

CHPA staff travel inside the Beltway and beyond

CHPA's David Spangler, vice president-international and assistant general counsel, traveled to Hollywood, Florida, March 30-31 to participate in ACNielsen's "Consumer 360 Conference," which focused on marketing information developments...

CHPA's Marcia Howard, Ph.D., associate director of scientific affairs, attended a U.S. Department of Health and Human Services meeting March 24-25 in Bethesda, Maryland. "Assessing the Health Effects of Bioactive Food Components" was the conference theme (See related story)...

CHPA's Doug Bierer, Ph.D., vice president of regulatory and scientific affairs, and Marcia Howard, Ph.D., associate director of scientific affairs, attended the Institute of Food Technologists' (IFT's) press conference March 24 at the National Press Club in Washington, D.C. IFT released its expert report on functional foods during the event (See related story)...

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Industry News
Federal Agency Update

FDA advisory committees recommend safety profile for Rx-to-OTC switch of corticosteroids

Two FDA expert panels recommended March 24 that dermatologic corticosteroids approved for OTC marketing should be shown to cause zero serious systemic effects in clinical trials with at least 1,000 patients. FDA's Nonprescription Drugs Advisory Committee met in joint session with the Dermatologic and Ophthalmic Drugs Advisory Committee to consider what safety profile would be needed for a dermatologic corticosteroid to be switched from Rx-to-OTC status. 

The meeting was convened by FDA in light of interest expressed by several manufacturers in switching corticosteroids with higher potency hydrocortisone, the only corticosteroid currently allowed to be marketed OTC. The joint advisory committee was asked to consider a proposed paradigm to evaluate potential systemic effects, including adrenal suppression, and localized skin effects. Committee members were told to keep in mind that any corticosteroid product made available OTC would likely be labeled with symptom-relief claims and directions for limited duration of use similar to those for currently available OTC products.

During the open public hearing portion of the meeting, J. Charles N. Ellis, M.D., University of Michigan Medical School, presented results from a survey study that showed consumers appropriately use OTC corticosteroids containing hydrocortisone according to label directions. The study, sponsored by GlaxoSmithKline, will be published in the Journal of the American Academy of Dermatology. Advisory committee members, however, were unconvinced that labeling warning statements would be sufficiently effective to prevent excessive use of an OTC corticosteroid product. A majority of committee members voted that no dermatologic corticosteroid should be approved for OTC availability if “maximal use”—high frequency and duration of application on at least 30 percent of the body surface—could potentially be fatal.

CHPA contact:  Dr. Lorna Totman |  Back to the top


NDAC recommends clinical trials to demonstrate efficacy of healthcare antiseptic products

FDA’s Nonprescription Drugs Advisory Committee (NDAC) unanimously rejected industry recommendations concerning the use of microbiologic surrogate endpoints to demonstrate the effectiveness of healthcare personnel hand washes, surgical hand scrubs, and patient preoperative skin preparations. NDAC members met March 23 to address outstanding issues, particularly concerning lowering threshold criteria for bacteria count reduction in effectiveness testing, required under the proposed monograph for healthcare antiseptics.

The Soap and Detergent Association and the Cosmetic, Toiletry, and Fragrance Association petitioned FDA to establish efficacy criteria for surrogate endpoints that reflect the performance of currently recognized effective products. The industry coalition asserted at the NDAC meeting that clinical effectiveness trials on healthcare antiseptics are impractical and cited medical literature reports supporting the conclusion that the industry-proposed microbial reduction criteria reflect clinical benefit.

Nevertheless, NDAC recommended that clinical trials be done to prove clinically relevant efficacy of healthcare antiseptics. The committee also recommended that antiseptic products be labeled with information for clinicians about what effectiveness criteria the product met in bacterial reduction tests and with a statement about the lack of data to support correlation of product performance in surrogate tests with true clinical benefit.

 CHPA contact: Dr. Lorna Totman |  Back to the top


Risk minimization guidances issued

FDA announced in a March 24 news release that the Agency has issued three final guidance documents entitled Premarketing Risk Assessment, Development and Use of Risk Minimization Action Plans, and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. According to a March 29 Federal Register notice, the guidances are intended to help assess and monitor the risks associated with drugs and biological products in clinical development and general use.

The Premarketing Risk Assessment guidance provides specific recommendations to companies for improving the assessment and reporting of safety during clinical drug development trials. The Development and Use of Risk Minimization Action Plans document suggests various tools to minimize the risks of products. The Pharmacovigilance Practices and Pharmacoepedemolgic Assessment guidance focuses on recommended reporting and analytical practices to monitor the safety concerns of products in general use.

FDA's Steve Galson, M.D., acting director, Center for Drug Evaluation and Research, says that the finalization of the documents fulfills one of the five initiatives announced by the Agency in November 2004 to further strengthen its drug safety program (See November 19, 2004, XNL). "Continuing to improve the way safety is assessed and monitored will lead to the earlier identification of safety problems and enable a more proactive approach to minimizing these risks," Galson asserted.

CHPA contact: Dr. Lorna Totman |  Back to the top


FDA, DIA schedule meeting on combination products and mutually conforming labeling

FDA, together with the Drug Information Association (DIA), announced a public meeting in the March 28 Federal Register to solicit input from stakeholders on the legal and public health issues that arise when sponsors seek to develop or market one type of drug, device, or biological product to be labeled for use with a different type of product that is already approved, under mutually conforming labeling. The meeting will be held May 10 from 8:30 a.m. to 5:00 p.m. in Bethesda, Maryland.

FDA notes that an increasing number of combination products are being developed by two independent sponsors that work together to bring the products to the marketplace with mutually conforming labeling. There are instances, however, in which the two sponsors do not work together because the sponsor of the approved product refuses to submit a supplemental application to include the new indication and route of administration in the product labeling.

The Agency is concerned that valuable new products may not be marketed because of sponsor fears about mutually conforming labeling. During the May 10 meeting FDA will explore, among other issues, whether the Agency should consider reviewing and potentially approving a new product labeled for use in conjunction with an approved product when there is no supplement for the combined use.

Persons wishing to speak at the public meeting should contact DIA's Amanda Carmody by April 26. Written comments are due by July 8.

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FDA's Food Advisory Committee seeks industry rep

FDA issued a request in the March 22 Federal Register for nominations for a nonvoting industry representative to serve on the Center for Food Safety and Applied Nutrition's (CFSAN's) Food Advisory Committee. This committee provides advice and recommendations primarily to the director of CFSAN on emerging food safety, science, nutrition, and other food-related health issues.

Nominees may either be self-nominated or nominated by an organization.  Industry organizations wishing to participate in the selection of the industry representative should send a letter indicating this interest to FDA. All nominations and letters of interest should be sent to CFSAN's Marcia Moore by April 21.

CHPA contact: Dr. Marcia Howard |  Back to the top


FDA's Science Board meets on drug safety programs

FDA published a notice in the March 31 Federal Register announcing that its Science Board will meet April 15 in the Agency's Rockville, Maryland, location. FDA has convened the meeting for the Science Board to discuss the following two topics: 1) The Agency's pre- and post-marketing safety programs for drugs and biologics, and 2) Good Manufacturing Practices for vaccines; blood; and cell, tissue, and gene products.

The meeting is open to the public and FDA welcomes oral presentations as well as written submissions. Those wishing to speak at the meeting should notify FDA's Jan Johannessen before April 8. Written comments are due April 8.

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FDA reviews its 2004 achievements

FDA issued a talk paper March 22 on what the Agency deems to be its major accomplishments from last year. FDA specifically cited the following five areas as among the goals it achieved in 2004:

• New initiatives were introduced to help combat critical health threats such as obesity, counterfeit drugs, and medical errors;

• A greater number of products were approved, including many new generics;

• The security of the food supply was strengthened against potential bioterrorist acts;

• Food safety was improved through major initiatives and actions; and

• The paperwork process was streamlined in an effort to reduce errors, reform outdated practices, and enhance new product innovation.

In the area of drug safety, FDA pointed to the measures initiated by the Agency's Acting Commissioner Lester M. Crawford, Ph.D., D.V.M., in November of last year (See November 19, 2004, XNL). Additional efforts touted in the talk paper include the Agency's current Good Manufacturing Practices overhaul and its Critical Path Initiative.

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HHS Secretary Leavitt increases his senior staff by six

U.S. Department of Health and Human Services (HHS) Secretary Michael O. Leavitt has named new six additions to serve on his team. The appointments include a chief of staff, deputy chief of staff, and four counselors.

According to a March 28 HHS news release, Rich McKeown was selected as chief of staff. McKeown previously served as chief of staff to Secretary Leavitt at the U.S. Environmental Protection Agency and the Utah Governor's Office. At HHS, McKeown will oversee operations for all department functions.

Veteran HHS employee Kerry Weems was chosen as deputy chief of staff. Weems has worked at HHS for 21 years, most recently serving as acting assistant secretary for budget, technology, and finance. In this new role, Weems will assist the chief of staff and serve as a policy advisor.

Additional appointments include Jennifer Young as acting senior counselor for health policy, William F. Raub as acting counselor for science policy, Richard M. Campanelli as acting counselor for human service policy, and Natalie Gochnour as counselor to the secretary.

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Nutritional Supplement Activities

Bioactive food components considered at HHS ad hoc meeting

A U.S. Department of Health and Human Services (HHS) federal ad hoc working group held a meeting March 24-25 on "Assessing the Health Effects of Bioactive Food Components" at the National Institutes of Health (NIH) campus in Bethesda, Maryland. Presentations at the two-day meeting were given by a host of speakers from the United States and abroad, including Joseph M. Betz, Ph.D., Office of Dietary Supplements, NIH;, Paul M. Coates, Ph.D., Office of Dietary Supplements, NIH;, Patricia M. Danzon, Ph.D., University of Pennsylvania; John W. Erdman, Jr., Ph.D., University of Illinois; Barbara O. Schneeman, Ph.D., Center for Food Safety and Applied Nutrition, FDA; Michael Müller, Ph.D., Wageningen University; and Martin Wiseman, Ph.D., University of Southampton and World Cancer Research Fund International.

A variety of topics, such as bioactive food components in global public health, challenges in characterizing and identifying components in botanical products, and nutrigenomics, were contemplated by meeting participants in order to begin identifying guiding principles for categorizing, prioritizing, and assessing the health effects of bioactive food components. NIH scientific consultant and meeting organizer Leila G. Saldahna, Ph.D., presented a summary of comments submitted in response to a September 2004 Federal Register notice on a proposed definition of bioactive food components. CHPA submitted comments on this topic November 1, 2004.

At the conclusion of the symposium, it was generally agreed that more dialogue is necessary to achieve the goals of the ad hoc working group. A case study on this subject will be held April 1 in San Diego, California. More information on that event is available online.

 CHPA contact: Dr. Marcia Howard |  Back to the top


IFT releases functional foods report

The Institute for Food Technologists (IFT) held a press conference March 24 in Washington, D.C., to announce its expert report on functional foods. This is the third expert report released by IFT, a not-for-profit international scientific society comprised of persons working in food science, technology, and related professions, and represents insights generated by extensive deliberation of the multidisciplinary panel.

The report’s recommendations to ensure functional foods are safe and effective are:

• Identifying the relationship between a food component and its health benefits;

• Demonstrating efficacy and determining intake levels needed for the desired effect;

• Demonstrating safety at efficacious levels;

• Developing suitable food vehicles for the food components;

• Demonstrating scientific sufficiency to support evidence of efficacy;

• Communicating benefits to consumers; and

• Conducting in-market confirmation for efficacy and safety.

Speakers at the press conference, which included Diane F. Birt, Ph.D., Iowa State University; Fergus Clydesdale, Ph.D., University of Massachusetts, Amherst; and Gilbert A. Leveille, Ph.D., Cargill, Inc., outlined a seven-step scientific process for introducing functional foods into the marketplace. They also recommended creating incentives for companies that invest in functional food research, noting that citizens will ultimately benefit from increased research. Additional key points the speakers noted for consideration include collaboration between regulatory agencies, manufacturers, and the scientific community to generate effective and efficient research in the area of functional foods, scientific credibility, and clarification of food claims to facilitate better choices by consumers.

A copy of the full report, which will be used in outreach efforts to legislators, regulators, and the media, is available online.

CHPA contact: Dr. Marcia Howard |  Back to the top


 

International Perspectives

European Commission seeks to improve mutual recognition procedure

The European Commission invites public comments on its draft proposal, Guideline on the Definition of a Potential Serious Risk to Public Health, in the context of the European Union's (EU's) mutual recognition procedure for medicinal products.

The mutual recognition procedure has proven difficult in the past when EU member states objected to a marketing authorization from other member states. In the 2004 revision to EU pharmaceutical law, the standard for objections was raised to "serious risk" in an effort to reduce the number of objections. The commission has now spelled out what it considers such a risk, including citing examples in the areas of efficacy, safety, quality, overall risk-benefit, and product information.

The Association of the European Self-Medication Industry (AESGP) is generally supportive of the draft guideline and is in the process of preparing comments for the commission.

Implementation developments under the 2004 EU pharmaceutical law is one of the issues that will be discussed during the June 1-3 World Self-Medication Industry and AESGP meeting in Geneva, Switzerland (See March 4 XNL).  Program and registration materials are available online.

CHPA contact: David Spangler |  Back to the top


In Brief

FDLI annual educational conference explores every avenue of food and drug regulation

With the theme of "Preparing for the Next Century of Food and Drug Regulation," the Food and Drug Law Institute's (FDLI's) annual meeting promises to leave no food and drug regulation stone unturned. Scheduled for April 6-8 in Washington, D.C., this year's meeting features a special panel of experts who will debate the effectiveness of FDA's drug safety program. In addition, a series of concurrent sessions will cover such diverse topics as international harmonization, clinical trial registries, FDA center priorities, and dietary supplement ingredients. Among the scheduled FDA speakers are Lester M. Crawford, D.V.M., Ph.D., acting commissioner, and John M. Taylor III, associate commissioner for regulatory affairs. For more information on the conference, visit FDLI online.

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Take a crash course “inside-the-Beltway”

TheCapitol.Net recently released its spring 2005 course catalog on legislative, communications, and media training educational opportunities. All classes are held in Washington, D.C., and can be tailored for on-site training. Courses range from two hours to five days in length, and include seminars on preparing and delivery congressional testimony, communicating effectively with Capitol Hill, and advocacy campaigns in Washington. For more information and to register, visit www.TheCapitol.Net.

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