Association News

Suydam highlights safety of OTC NSAIDs at meeting of FDA advisory committees

CHPA President Linda A. Suydam, D.P.A., presented the OTC manufacturers’ perspective on the safety of nonsteroidal anti-inflammatory drugs (NSAIDs) February 17 before FDA's joint meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. While the meeting focused on overall benefit-to-risk considerations for COX-2 selective NSAIDs, Suydam's presentation drew a clear distinction between the use of Rx drugs and OTC medicines, and emphasized that OTCs differ from prescription drugs in indication, dose, and duration of use:

• All OTC analgesics are safe and effective when taken properly. No one should take more than the recommended dose or take an OTC analgesic for an extended period of time without consulting a physician.

• One important facet to the difference between OTC medicines and prescription drugs is the OTC label, which contains information deemed necessary by both the manufacturer and FDA, and provides important information consumers use to decide if the medicine is appropriate for use, how to take the product, and when to see a physician, if necessary.

• Naproxen was thoroughly reviewed in 1993 at a joint meeting of the Arthritis Drugs and Over-the-Counter Drugs advisory committees, was confirmed as effective and safe, and FDA switched the drug from prescription to over-the-counter status the following year.

• The OTC naproxen label clearly states, among other warnings, to stop use and ask a doctor if any new symptoms appear or if pain becomes worse or lasts more than 10 days.

• OTC analgesics are not intended to be used for long duration unless under the direction of a physician, which is clearly stated on the label.

As with any medicine, concluded Suydam, carefully reading and following label directions on over-the-counter medicines is the best way for consumers to ensure safe and effective use.

CHPA has additional information about NSAIDs online.

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


Time is drawing nigh for the AEC

There is still time to register for CHPA's Annual Executive Conference (AEC), but the clock is ticking. A yearly highlight for the industry, the AEC is set for March 10-12 at The Fairmont Turnberry Isle Resort & Club, Aventura, Florida.

Friday morning sessions have a strong policy focus

The AEC business program kicks off Friday morning, March 11, at a breakfast sponsored by Hearst Magazines. Addressing the group will be former U.S. Senator John Breaux. Breaux represented his Louisiana district in the House of Representatives for 14 years, and then served as a member of the U.S. Senate from 1986 until his retirement this past term. He is well known for his work on health and financial issues during his congressional service and will be sharing his perspectives on where healthcare policy is headed.

Next on the Friday program is the First General Session. Information Resources, Inc. (IRI), is sponsoring the session at which Stephen Johnson, IRI's executive vice president and general manager, Healthcare Solutions Group, will preside.

The General Session features CHPA Chairman Tim Hayes, senior vice president and region head, North America, Bayer HealthCare LLC, and CHPA President Linda A. Suydam, D.P.A., who will provide members with their "State of the Association" addresses.

Keynoting the First General Session is FDA's Acting Deputy Commissioner for Operations Janet Woodcock, M.D. Woodcock, who joined the Agency in 1986, served as the director of FDA's Center for Drug Evaluation and Research from 1994 until stepping into the deputy commissioner role in 2004. She has spearheaded the Agency’s work on the critical path initiative for medical product development and is heavily involved in FDA’s plans to strengthen its drug safety program.

Another new addition to the Wall Street panel is a vice president of the Boston Consulting Group (BCG) Sharon Marcil, who will serve as the fourth panelist. BCG provides companies with strategy and management advice to help create and sustain competitive advantage. She has a depth of experience in BCG's consumer products practice and will add her own unique perspective to the panel.

Register now!

February is more than half over and the AEC just around the bend. For registration information, members should visit the Members Only section of CHPA's web site. Please note that CHPA's room block at the hotel was released February 8. For hotel reservations, visit www.fairmont.com/tir/chpa.

CHPA contacts: Kass Kassouf and Maria Sarabia |  Back to the top


The 2005 RSC will explore consumer behavior

Best-selling author Mary Lou Quinlan will keynote the meeting

Make plans now to attend CHPA’s 2005 Regulatory and Scientific Conference (RSC) May 5-6 at the Mandarin Oriental hotel in Washington, D.C. It’s all about “Choices Consumers Make: Understanding Consumer Behavior to Enhance Self-Care.”

Quinlan has earned many awards, including Woman of the Year from Advertising Women of New York in 1995 and the 1997 Matrix Award from New York Women in Communications. In 2003, she penned the best-selling marketing book, Just Ask a Woman, Cracking the Code of What Women Want and How They Buy. Capitalizing on her extensive career experience, Quinlan will enlighten RSC attendees about what women say and do regarding healthcare.

Others presentations at the RSC will explore the fundamentals and application of consumer research methods. Confirmed speakers include Gerald Zaltman, Ph.D., a member of Harvard University’s ”Mind, Brain, and Behavior Interfaculty Initiative” and co-director of the Mind of the Market Laboratory, and Steve Bodhaine, chief operating officer of The Segmentation Company, a division of Yankelovich Partners.

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Regulatory and Scientific Conference
May 5-6, 2005
Mandarin Oriental hotel
Washington, D.C.
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The RSC also features three workshops that provide opportunities for learning and interaction among conference participants. The workshop topics include consumer segmentation, questionnaire development, and understanding consumer preferences and decisions related to OTC products.

The RSC program and registration materials will be available soon on CHPA's web site.

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


Industry News
Nutritional Supplement Activities

CHPA tells FDA that dietary ingredients should be defined as DSHEA intended

CHPA filed comments with FDA February 1 urging the Agency not to alter the broad definition of dietary ingredients as stated in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The Association submitted its comments in response to an FDA request for information in the October 20, 2004, Federal Register concerning the Agency's premarket notification program for new dietary ingredients (NDIs) (See October 22, 2004, XNL).

The Association also recommended that "old" dietary ingredients, or those marketed prior to October 15, 1994, should be grandfathered, regardless of their omission from current dietary ingredient publications, if a manufacturer is able to produce legitimate documentation of its marketing history. CHPA pointed out that this issue also is made clear in DSHEA.

In addition, the Association supported the inclusion of the types of chemical identifiers for NDIs, such as chemical name, empirical and structural information, and quantitative composition, as listed in FDA's Federal Register notice. CHPA noted, however, that specific information submitted in an NDI filing should be provided on an ingredient-specific basis.

To establish that a dietary ingredient is “reasonably expected to be safe,” CHPA recommended that FDA use a model similar to that of GRAS (generally recognized as safe) and that the Agency consider safety evaluations conducted by outside, independent experts.

Finally, CHPA applauded FDA for undertaking the task of providing clarifying information on the premarket notification program and encouraged continued dialogue between the Agency, industry, and other interested parties as a guidance is developed.

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


Federal Agency Update

Acting FDA Chief Crawford is slated for a permanent role as commissioner

President George W. Bush issued a February 14 White House statement announcing his intention to nominate Lester M. Crawford, D.V.M., Ph.D., as the commissioner of FDA. Crawford was named deputy commissioner of the Agency in February 2002 and is currently serving his second stint as acting commissioner since Mark B. McClellan, M.D., Ph.D., vacated his post last March.

In response to this news, U.S. Department of Health and Human Services Secretary Michael O. Leavitt released a statement declaring Crawford to be an outstanding choice for the position. "With Dr. Crawford's leadership, FDA will provide the world's safest drugs and empower citizens with the tools they need to make informed choices about their health," Leavitt said.

Before coming to FDA, Crawford served as the director of the Center for Food and Nutrition Policy at Georgetown University and Virginia Tech. He is a member of the National Academy of Sciences Institute of Medicine and a fellow of both the Royal Society of Medicine in the United Kingdom and the International Society of Food Science and Technology. Crawford also acted as an advisor to the World Health Organization for almost 20 years.

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FDA seeks $1.9 billion for FY 2006

President George W. Bush released his fiscal year (FY)  2006 budget of the United States Government February 7. Included in the $642 billion U.S. Department of Health and Human Services' budget proposal is a $1.9 billion request for FDA, which is a 4.5 percent increase over FY 2005. While a large percentage of the funding is designated to the Agency's counterterrorism program, there are monies available for the safety surveillance program for drugs currently marketed.

The President also is proposing additional resources for federal law enforcement and drug interdiction operations through the Drug Enforcement Administration and the Office of National Drug Control Policy (ONDCP). These proposals, however, are accompanied by a substantial reduction in federal assistance to state and local law enforcement.

Following the release of the President's proposed budget, U.S. Representative Mark Souder (R-Ind.), chairman of the Subcommittee on Criminal Justice, Drug Policy, and Human Resources, held a hearing February 10 entitled “Fiscal Year 2006 Drug Budget.” Chairman Souder and other subcommittee members expressed some concerns over program cuts and issued public assurances that the budget proposal would be closely scrutinized.

FDA's FY 2006 budget request is available online.

CHPA contacts: Kevin Kraushaar and Mike Becker |  Back to the top


NDAC to evaluate the plausibility of switching Rx topical corticosteroids

FDA issued a February 17 Federal Register notice announcing that the Agency's Nonprescription Drugs Advisory Committee (NDAC) will meet jointly with its Dermatologic and Ophthalmic Advisory Committee March 24 at the Hilton Washington D.C./North Gaithersburg in Gaithersburg, Maryland. The purpose of the meeting is to determine what safety factors should be considered in order to evaluate the Rx-to-OTC switch of topical corticosteroids.

According to FDA's advisory committee meeting agenda, the committee discussions will center specifically on what safety data are necessary to evaluate the potential for hypothalamic, pituitary, adrenal, and growth suppression as well as other systemic and local adverse events.

Interested parties may submit comments to the committees on this issue either in writing or by making an oral presentation at the meeting. Written comments should be submitted by March 17 to FDA's Teresa A. Watkins. Oral presentations will be scheduled between approximately 1:00 and 2:00 p.m. Those wishing to present oral comments should provide details to Watkins by March 17.

For up-to-date information on this joint meeting, contact FDA's Advisory Committee information line at 1(800) 741-8138 and enter code 3014512534 or 3014512541.

CHPA contact: Dr. Doug Bierer |  Back to the top

Drug Safety Oversight Board and increased transparency are part of FDA's new "vision"

U.S. Department of Health and Human Service Secretary Michael O. Leavitt and Acting FDA Commissioner Lester M. Crawford, D.V.M., Ph.D., proclaimed a new vision for FDA during a February 15 FDA briefing. According to an FDA Fact Sheet, Leavitt and Crawford are seeking to "promote a culture of openness and enhanced oversight within the Agency."

During his remarks, Crawford said that the new plan includes the creation of an independent Drug Safety Oversight Board (DSB) that will oversee the Center for Drug Evaluation and Research's management of drug safety and provide emerging information to healthcare providers and patients about medicine risks and benefits. He explained that the DSB will be made up of FDA staff and medical experts from other government agencies to be appointed by the FDA commissioner. The board also will consult with outside medical experts and patient and consumer groups.

Additionally, Crawford said that the new vision includes a measure to provide targeted drug safety information directly to the consumer. Crawford stated that FDA will increase the transparency of its decisionmaking process by expanding existing communication channels and establishing new ones. To help with this effort, the Agency is proposing a new Drug Watch web page where emerging data and risk information will be posted in the form of information sheets for healthcare professionals and consumers.

"The public has spoken and they want more oversight and openness," said Leavitt in an HHS press release concerning the new FDA vision. "They want to know what we know, what we do with the information, and why we do it. "

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FDA public hearing addresses the reporting of adverse events to institutional review boards

FDA announced in the February 8 Federal Register that it will hold a public hearing March 21 with the purpose of obtaining information on the submission and review of adverse events reported to institutional review boards (IRBs) during clinical investigations. The hearing will be held from 9:00 a.m. to 5:00 p.m. at FDA's Rockville, Maryland, location.

In its Federal Register notice, the Agency says it is aware the IRB community is concerned that the adverse event reporting process is burdensome, inefficient, and ineffective in providing it with the information necessary to ensure that human subjects are adequately protected during the course of a clinical study. FDA is holding the public hearing to better understand and ultimately address these concerns.

To present comments during the hearing, contact FDA's Nancy L. Stanisic by March 4. Written and electronic comments are due April 21. Because of limited seating, FDA recommends individuals register online for the hearing as soon as possible.

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ICH draft guidance on Q8 pharmaceutical development is available for comment

FDA issued a notice in the February 9 Federal Register stating that a draft guidance prepared by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is now available for public review and comment.

The draft document, entitled Q8 Pharmaceutical Development, is intended to help with the development of studies that will provide scientific understanding to support the establishment of specifications and manufacturing controls and serve as the basis for evaluating risk management over the life cycle of the pharmaceutical product.

FDA notes that the draft guidance does not apply to submissions for drug products during the clinical research stages. The Agency, however, says that the principles described in the document are important to consider during drug product development.

Comments on the draft are due April 11.

CHPA contact: Fred Razzaghi |  Back to the top


In Brief
 

2005 CHPA member dues reminder CHPA member dues statements for 2005 were sent out December 1, 2004. Dues for Active members should be calculated on total net sales of OTC and nutritional supplement products. For advertising agency members, dues should be calculated on total billings for these products. All Active and Associate member dues payments were due January 31, 2005. Payments not received by February 28, 2005, are subject to a one percent per month late fee. Please note: 2005 Annual Executive Conference registration confirmations will be provisional until member dues are paid. If you have not received your statement or have questions, please contact CHPA’s Roman Blazauskas or Hyacinth Fray via e-mail or at (202) 429-9260.

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FDANews audioconference teaches how to prepare for systems-based inspections

FDANews is offering an audioconference on preparing for systems-based inspections February 28 from 1:30 – 3:00 p.m. The 90-minute audioconference will be hosted by Martin Browning, founder and president of EduQuest, and former FDA investigator. Browning will share his insights on the systems-based approach to FDA inspections, touching on such topics as the six systems and critical elements Agency investigators are targeting, the role of risk management, and the importance of conducting mock inspections. For more information on this program, visit www.fdanews.com/wbi/conferences/inspections.html.

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