AEC 2003 is destined to be a success, thanks to the generosity of sponsors

New CHPA sponsors Three additional member companies have added their support for the 2003 Annual Executive Conference (AEC): DPT Laboratories, Ltd., is offering an all-day hospitality lounge during AEC registration on Thursday, March 13.
G&J USA Publishing will be hosting an after-hours cocktail get-together in the main lobby of the hotel on Thursday evening, March 13.    Cardinal Health is supplying the welcome tote bags for the member products.

The final event of the conference, ACNielsen’s "Sports Night," promises to be an evening of fun and casual competition, ending with the highlight of the evening, the grand prizes:

• Arnold Worldwide New York – set of new Titleist golf clubs
• Bates Worldwide – $1,000 Sports Memorabilia gift certificate
• Carrafiello Diehl & Associates, Inc.– Skip Barber School for Auto Racing gift certificate for two
• Grey Worldwide, Inc.– Apple iPod digital music player
• Saatchi & Saatchi – SONY flat-screen television
• The Seiden Group – New York weekend for two at Sherry Netherland Hotel/Yankees tickets
• J. Walter Thompson Company – diamond sports jewelry

__________________

Additional grand prize sponsors
 are most welcome! Contact 
CHPA's Meetings Department
 for details
__________________

Additional sponsor opportunities

There are still a few sponsorship opportunities available for March 14. The AEC buffet lunch and coffee break for the concurrent sessions are still open to interested parties. Contact CHPA’s Kass Kassouf at kkassouf@chpa-info.org for more information.

Hotel room block to be released

CHPA’s room block at the Turnberry Isle Resort & Club will be released to the public February 13. Hotel space may be available after that date, but it cannot be guaranteed. We urge all members to protect a room now. You have until February 19 to cancel reservations without a penalty and still receive a refund.

CHPA contacts: Kass Kassouf and Maria Sarabia

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CHPA's MarketPlace 2003 is where the members will be

If you are a member of CHPA, you probably have at least heard about the Association's new venture called MarketPlace. But do you know why you should attend?  Because this is a once-a-year only, exclusive, member opportunity that offers over 10 hours of interaction between key executives from CHPA's Active and Associate member companies.

CHPA MarketPlace is going to be one amazing day of member meetings broken down into 20-minute time slots. Additional networking time is also provided by way of breakfast, lunch, and an early-evening reception.

CHPA staff will present a preliminary list of exhibitors  at the March 13-15 Annual Executive Conference (AEC). If you are an Associate member planning to participate in MarketPlace, please e-mail a list of 10 of the companies you would like to meet with to ptaylor@chpa-info.org no later than February 20. Be sure to also include a brief description of what you plan to present to those companies. Exhibitors are encouraged to tailor each presentation to each specific audience.

Special rate available! Exhibitors who register for both the AEC and CHPA MarketPlace are eligible for the special MarketPlace registration fee of $900; register online using the AEC registration. MarketPlace-only registration materials will be be available shortly.

CHPA contacts: Ted Peterson and Phyllis Taylor

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OTCs receive a healthy boost in FDA's FY 2004 budget proposal

President George W. Bush's FDA budget request for fiscal year (FY) 2004 (October 1, 2003 - September 30, 2004) includes a $1 million increase for OTC medicines. This change, announced in a a February 3 FDA Talk Paper, is the first time in years that a specific monetary increase for OTCs has been made.  The entire budget request for the Agency totals $1.7 billion.

The Agency intends to use the $1 million increase to:

• Improve the OTC drug review process;
• Expedite the review of Rx-to-OTC switches and evaluate five to 10 foreign OTC drugs as potential U.S. switch candidates; 
• Develop and work toward finalizing Monographs for OTC analgesics, antiseptics, laxatives, and sunscreens;
• Fund consumer behavior research on OTC risk management; and
• Initiate a process and establish timelines for completion of unfinished OTC monographs.

According to FDA's FY 2004 budget report, Promoting Public Health Through Patient, Food, and Consumer Safety, the Agency plans on spending approximately $10.4 million on the entire OTC drug program. The U.S. Congress will begin the appropriations hearing process in the near future.

CHPA contact: Kevin Kraushaar

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Draft guidance for industry on 21 CFR Part 11 is withdrawn

FDA announced in the February 4 issue of the Federal Register that it has opted to withdraw its draft guidance entitled "Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records." According to the notice, the Agency believes that the guidance, issued in November of last year, may no longer represent FDA's approach under its current good manufacturing practice (cGMP) initiative (see August 30, 2002, XNL). FDA plans to reevaluate the draft guidance under the cGMP initiative to determine whether the guidance should be reissued.

CHPA contact: Fred Razzaghi

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FDA seeks information to update its mercury list

In accordance with the Food and Drug Administration Modernization Act of 1997, FDA is currently seeking information to update an Agency document on drug and food products that contain mercury compounds. As announced in the February 3 Federal Register, a list of products was compiled and made available in document form in November 1999 (see December 3, 1999, XNL). Because FDA is aware that some of the products on the list may have been reformulated since that time, it is calling on manufacturers and distributors to advise the Agency of any such changes. In addition, FDA is requesting copies of the revised labeling for products that have been reformulated. All comments and information regarding this issue are due by April 4. A copy of the 1999 mercury list entitled "Mercury in Drug and Biologic Products" is available at www.fda/gov/cder/fdama/mercury300.htm.

CHPA contact: Dr. Lorna Totman

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Rosebraugh named deputy director of CDER's OTC division

Effective January 27, Curtis Rosebraugh, M.D., assumed the position of deputy director of the Division of OTC Drug Products in FDA's Center for Drug Evaluation and Research (CDER). Rosebraugh, who is board certified in internal medicine, first joined FDA in 2000 as a medical officer in the Division of Pulmonary Drug Products. Prior to that he was completing a fellowship in clinical pharmacology at Georgetown University and a Masters in public health from the Johns Hopkins School of Public Health. During his time with the Agency, he has served on several committees and has been actively involved in the Center for Education Research and Therapeutics program at Georgetown University.

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FDA amends tentative schedule of advisory committee meetings

FDA published an amended tentative schedule of 2003 public advisory committee meetings in the February 7 Federal Register. The tentative dates for 2003 Nonprescription Drugs Advisory Committee (NDAC) meetings have changed since the original schedule was posted in the December 19, 2002, Federal Register (see December 20, 2002 XNL). The new dates are currently listed as June 12-13 and September 16-17. The tentative dates for the Dietary Supplements Sub-Committee are March 27-28 and September 22-23. Any additional changes to the schedule will be posted on FDA's web site at www.fda.gov/oc/advisory/default.htm. 

CHPA contact: Dr. Lorna Totman 

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FDA issues proposed rules impacting the registration, importation of dietary supplements

FDA released proposed regulations in the February 3 Federal Register implementing portions of the Public Health Security and Bioterrorism Act that Congress enacted last June. These provisions will require all food facilities that manufacture, process, package, or hold food that is intended for consumption in the United States (including dietary supplements) to register with the Agency. Additionally, the law requires that persons importing articles of food (including dietary supplements) into the United States must provide FDA with prior notice of the importation before arrival.

Facilities registration

This proposed regulation requires that all facilities where "food," including dietary supplements, is manufactured, processed, packaged, or held, register with FDA, providing the name and type of the facility, address, and an emergency contact for the facility. A foreign facility also must register if it is the last place in which food is processed or packaged prior to being imported into the United States. A facility must register under Bioterrorism Act requirements, even if it is already registered with FDA pursuant to other laws. Although this information will not be publicly available, FDA may share its database of registrants with state authorities and other government agencies. No registrations will be accepted prior to October 12, 2003, but all facilities must be registered by December 12, in compliance with the deadline in the statute. There are both civil and criminal penalties for failure to register. The proposed regulation is available at www.fda.gov/OHRMS/DOCKETS/98fr/03-2443.pdf. Comments are due by April 4.

Prior notice of imports

This proposed regulation implements the statutory requirement that FDA receive prior notification of all food imports before they arrive in the United States. Under the regulations, this notice must be received no more than five days before arrival and no less than noon on the calendar day prior to arrival. These notifications must be made electronically and differ from the existing notice requirements for the U.S. Customs Service. Once a notification has been filed within the permissible time frame, it may be amended up to two hours before arrival of the food articles. The proposal specifies that each article, and not merely the entire shipment, must be identified in the notice. If an importer fails to properly file these notices, the article of food may be detained or seized with the importer responsible for any transportation or storage costs. The proposed regulation is available at www.fda.gov/OHRMS/DOCKETS/98fr/03-2444.pdf. Comments are due by April 4.

Implementation costs

In a February 4 statement issued by U.S. Department of Health and Human Services Secretary Tommy G. Thompson, $20.5 million of FDA's fiscal year 2004 budget will be directed toward activities that implement the Bioterrorism Act. Of that amount, $10.5 million will be used to implement the registration and import systems.

CHPA contacts: Steve Mister and Dr. Leila Saldanha

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NCCAM selects its first deputy director

Following a nationwide search, the National Institutes of Health (NIH) announced January 27 that  Margaret A. Chesney, Ph.D., has been chosen as the first deputy director of the National Center for Complementary and Alternative Medicine (NCCAM). Chesney's recent career experience includes acting as a senior visiting scientist in NIH's Office of Women's Health and serving as a professor of medicine and epidemiology at the School of Medicine, University of California, San Francisco.

In her new NCCAM role, Chesney will work with Stephen E. Straus, M.D., director of NCCAM, in planning, directing, and managing the programs and resources of the center. She officially assumes these duties February 10.

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Staff travel inside the Beltway and beyond

As part of her ongoing visits to member companies, CHPA President Linda Suydam traveled to Chattem, Inc. in Chattanooga, Tennessee January 21-22 to meet with CHPA board member Zan Guerry and Alec Taylor. She also paid a visit to CHPA board member Peter Miller of Johnson & Johnson • Merck Consumer Pharmaceuticals Co., and CHPA board member Bill McComb of McNeil Consumer & Specialty Pharmaceuticals in Philadelphia, Pennsylvania, January 29  . . . 

Ted Peterson, vice president for corporate development, and David Spangler, vice president - international and assistant general counsel, joined CHPA Business Program Committee Chairman Pat Lonergan of NUMARK Laboratories, and CHPA Chairman Dick Green of Blistex, Inc., in Chicago, Illinois, January 27 to meet with Annual Executive Conference sponsors Cargill Health & Food Technology and Information Resources, Inc. . . .

CHPA President Linda Suydam attended a White House briefing January 30 to hear about President George Bush's economic plan as outlined in his recent State of the Union address . . .

Dr. Lorna Totman, senior director of scientific affairs and toxicology, attended a session on cholesterol lowering drugs at the February 3 Annual Winter Meeting of the Toxicology Forum in Washington, D.C. . . . 

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PQRI conference to focus on good regulation through good science

The Product Quality Research Institute (PQRI) is planning a conference for April 3-4 in Arlington, Virginia. The conference program is heavily weighted with expert speakers representing academia, government, and industry who will discuss a wide variety of regulatory and scientific topics. Day one of the event includes four PQRI breakout committee sessions hosted by members of the drug substance technical committee, drug product technical committee, biopharmaceutics technical committee, and manufacturing technical committee. Day two includes a morning address by Janet Woodcock, M.D., director, Center for Drug Evaluation and Research (CDER), FDA, who will discuss CDER's priorities, good manufacturing practices, and where PQRI fits in the process. For more information about the conference, contact Sylvia Gantt at GanttS@pqri.org. 

PQRI is a non-profit corporation that serves as a neutral forum for academia, government, and industry to conduct research with the goal of reducing regulatory burden through sound science. CHPA is one of the founding member organizations of PQRI and serves on its steering committee. For more information about PQRI, visit www.pqri.org.

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FDA announces town meeting for small pharmaceutical manufacturers

FDA has scheduled a town meeting for small businesses regarding the Agency's requirements for approval and marketing of drug products. The meeting will be held March 5 from 12:00 to 4:00 p.m. at the William J. Green Federal Building in Philadelphia, Pennsylvania. Agenda topics for discussion include: OTC monographs, labeling, registration, listing, Agency meetings process, imports and exports, financial incentives, and navigating the FDA web site. The complete meeting announcement is available in the February 4 Federal Register. To attend, complete the meeting registration form by February 14.

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Pharmaceutical Advisory Committee to meet in March

A public meeting of FDA's Pharmaceutical Advisory Committee has been scheduled for March 12-13. As announced in the February 3 Federal Register, the meeting agenda for the first day includes a discussion on topical dermatological drug product nomenclature. Among the items to be discussed on the second day are the future direction of the Pharmacology/Toxicology Subcommittee and dose content uniformity in aerosol products. The meeting will be held on both dates from 8:30 a.m. to 5:00 p.m. at the Center for Drug Evaluation and Research Advisory Committee conference room in Rockville, Maryland. For more information, contact Kathleen Reedy at REEDYK@cder.fda.gov.

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Speakers at FDLI's annual conference to share formulations for success

The Food and Drug Law Institute is holding its 46th annual educational conference March 31-April 2 in Washington, D.C. "Regulation, Science, Business, and the Law: Formulations for Success," will present over 100 speakers discussing and debating the critical issues facing FDA-regulated industries. It also provides opportunities for networking with peers in industry, government, and the private bar. For more information or to register for the conference, visit www.fdli.org.

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CHPA Annual Executive Conference
March 13-15, 2003
Turnberry Isle Resort & Club
19999 West Country Club Drive
Aventura, Florida

CHPA MarketPlace
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

Research & Scientific Development Conference
November 6-7, 2003
The Fairmont Washington
2401 M Street, NW
Washington, D.C.

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