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March 7, 2003 |
No. 5-03 |
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CONTENTS CHPA applauds FDA's proposed standards for dietary supplements FDA gets clearance on dietary supplement label surveys FDA Commissioner supports additional funds for OTCs House Committee passes bill reform Exhibitor slots are filling up quickly for CHPA MarketPlace CHPA provides strategic recommendations to USP FDA holds small business town meeting New draft guidance reflects FDA's new thinking on Part 11 requirements FDA establishes public docket for cGMPs Bayer's Gary Balkema to chair WSMI Staff travel inside the Beltway and beyond GlaxoSmithKline's Cathy Sohn named HBA's 2003 "Woman of the Year" CFH offers telephone emergency stickers for National Poison Prevention Week Posters available from Poison Prevention Week Council Dickinson appointed president of CRN FDA's McClellan to keynote PQRI conference Use
the table of contents to jump directly to a story of interest, or use the
scroll bars. "Back to the top" options after every story will take
you to the beginning of the table of contents. |
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CHPA applauds FDA’s proposed standards for dietary supplements Consumers will benefit from uniform Good Manufacturing Practices CHPA and its members applaud FDA for releasing the Agency’s long-awaited proposed regulation to require current Good Manufacturing Practices (cGMPs) for the makers of America’s dietary supplement products. "CHPA has been on public record for many years as a proponent of increased standards for dietary supplement manufacturing," said CHPA President Linda A. Suydam, D.P.A. "Today’s move by FDA should further bolster consumer confidence in the dietary supplement products they take without limiting access to them." As proposed, the cGMPs will establish uniform standards for the dietary supplement industry to make certain that the products consumers are purchasing are of high quality and do not contain any contaminants or impurities. Additionally, dietary supplement products must be accurately labeled so that consumers have a full understanding of the type and amount of ingredients each individual product contains. "CHPA has always supported the full implementation of the Dietary Supplement Health and Education Act of 1994," said Sudyam. "The publication of the proposed cGMP rule is a good step toward that." The Association is also very supportive of FDA providing the industry with the opportunity to comment on the proposed rule. "We are still analyzing all of this new information," Suydam stated. "On whole, we are looking at the cGMPs in a very favorable light; however, there may be a few details that we need to work on," she added. "We look forward to working with FDA in this process." FDA plans to officially publish the proposed cGMP regulation in the March 13 Federal Register. The comment period is 90 days from that date. Click
here for a copy of FDA's press release. CHPA contacts: Donna Edenhart and Mimi Pappas
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FDA gets clearance on dietary supplement label surveys In a March 7 Federal Register housekeeping notice, FDA received an okay to conduct consumer surveys on food and dietary supplement labeling issues over the next year. FDA notes such surveys allow the Agency to test proposed label statements and gather information about consumer behavior to support regulatory and enforcement decisions. CHPA contact: David Spangler |
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FDA Commissioner supports additional funds for OTCs
All of these efforts would have significant consumer benefits by providing greater and broader access to OTC drug products, reducing some healthcare costs, and increasing competition in the market place. McClellan also stated in his remarks that OTC medicines play an increasingly vital role in America’s healthcare system and provide an effective means to reduce consumer costs for specified ailments. The trend toward self-medication has increased significantly in recent years as healthcare costs have risen and consumers want to be empowered to treat minor ailments with safe and effective OTC drugs. CHPA has written to the appropriations subcommittee in support of the FDA funding request. In a March 5 letter to House Agriculture Appropriations Subcommittee Chairman Henry Bonilla (R-Tex.) from CHPA President Linda A. Suydam, D.P.A., the Association reiterated its support for Rx-to-OTC switch activities at FDA. CHPA states that the money should be used to improve on the long history of cooperation between the Agency and the innovator drug companies and additional resources should be used at FDA to clean out the switch application "in-box" and expedite switch applications currently under review by the Agency. The commissioner is scheduled to testify before the Senate Appropriations Subcommittee March 19. The Congress will begin drafting the annual appropriations bill for the Agency in April. CHPA contact: Kevin Kraushaar |
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House committee passes legal reform The House Energy and Commerce Committee has completed action on the Health Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003, a bill that is intended to provide healthcare litigation reform. Most of the bill deals with the skyrocketing cost of medical malpractice insurance premiums. The bill also contains a Government Standards Defense (GSD) against punitive damages for medical products, including drugs, regulated by FDA. If it becomes law, the bill provides that drug manufacturers that comply with government regulations would have a defense against punitive damages, absent proof of fraud or malfeasance, which result from the use of these products. The U.S. House of Representatives is expected to take up the measure on the floor within the next two weeks. CHPA is working with Committee staff to include report language to insure that OTC drugs marketed pursuant to monographs and tentative final monographs are covered by the provision. CHPA staff contact: Kevin Kraushaar |
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Exhibitor slots are filling up quickly for CHPA MarketPlace
Interest in the inaugural CHPA MarketPlace event is better than anticipated! To date, 21 companies have taken advantage of the "early bird" exhibitor rate by registering with their Annual Executive Conference (AEC) registration. An additional 13 have signed-up in response to the request for appointments with specific companies (see February 7 XNL), for a total of 34 exhibitors to date. A list of these exhibitors will be provided to attendees at the AEC. Exhibitors are asked to send an e-mail to CHPA's Phyllis Taylor at ptaylor@chpa-info.org with a list of 10 companies with which they wish to make appointments. CHPA will schedule meetings with seven of those requested, with the remainder of the day’s appointments set up by each exhibiting company. Exhibitors are asked not to set their own appointments until after their CHPA-scheduled appointments are sent to them later this spring. This opportunity is available only to CHPA members, and space is limited to 50 tables. Additional information on registration and appointment scheduling will be sent in early April. CHPA encourages exhibitors to tailor each presentation to the specific company. This is a tremendous opportunity to present your company’s products and services to new or former customers. Don't wait – space is limited! Exhibitors who attend the AEC will receive the special CHPA MarketPlace Early Bird "Exhibitor" rate of $900. The regular exhibitor rate is $1,400 per table; the fee for each additional person per table is $300. CHPA staff contacts: Ted Peterson and Phyllis Taylor |
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CHPA provides strategic recommendations to USP CHPA's R. William Soller, Ph.D., senior vice president and director of regulatory and scientific affairs, was among the list of presenters at the hemiquinquennial conference of the United States Pharmacopeial Convention, Inc. (USP). The hemiquinquennial is USP's strategic planning conference that culminates in the organization's quinquennial meeting where USP adopts resolutions that represent strategic planning objectives for its five-year program of work. During his comments at the March 1-5 meeting, Soller called on USP to focus on a few specific areas in anticipation of the organization's quinquennial meeting in 2005. He urged the invited delegates to frame their proposals in the context of a risk management approach to USP priorities stressing that "risk management is what defines relevance for regulatory-related organizations today." Soller encouraged USP to define its program activities in the context of what is most important in assuring the safety of patients and consumers, through quality and information initiatives. He also recommended that USP define parameters for the resolution-generating process for the 2005 quinquinnial allowing for sufficient time for the organization to receive evidence-based proposals. Soller pointed out that this step would reduce the need to downgrade resolutions to feasibility studies versus actual programmatic activities. Finally, reporting briefly on a survey of CHPA members, Soller supported the many effective functions USP performs while commenting on the continuing need to focus on customer service. This focus will help USP receive wide support for its role in helping to ensure the quality and safety of drugs and dietary supplements. For a copy of Soller's presentation at USP's hemiquinquennial, click here. CHPA contact: Dr. Bill Soller |
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FDA holds small business town meeting FDA's Center for Drug Evaluation and Research held a small business town meeting for the pharmaceutical industry March 5 in Philadelphia, Pennsylvania. The meeting response was so great that FDA had to find a larger room and cut off registration at 150 people. Topics at the town meeting included:
A common theme at the meeting was the availability of practical information on FDA’s web site. Attendees learned that a promising new web site for the Agency's Division of Over-the-Counter Drug Products will be up and running soon. According to FDA, this site will have links to OTC-related Federal Register notices, ingredient references, and other regulatory information. Drug category and subject lists will link directly to monograph documents. CHPA contact: Dr. Lorna Totman |
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New draft guidance reflects FDA's new thinking on Part 11 requirements After withdrawing its first draft guidance on 21 CFR Part 11 (see February 7 XNL), FDA announced that it has completed a revised draft for industry called "Part 11, Electronic Records; Electronic Signatures—Scope and Application." According to the Agency's announcement in the February 25 Federal Register, this updated version better explains FDA's new thinking concerning Part 11 requirements and application. As a result of the development of its current Good Manufacturing Practice initiative (see February 21 XNL), the Agency stated that it is planning a reexamination of Part 11 as it applies to all FDA-regulated products. This may result in revisions to certain Part 11 provisions. The Agency also pointed out that while the reexamination is underway, it intends to exercise enforcement discretion to the validation, audit trail, record retention, and record copying requirements of Part 11. In addition to the availability of the new draft guidance, FDA also announced that it was withdrawing its Compliance Policy Guide and previously published Part 11 draft guidance documents on validation, glossary of terms, time stamps, and maintenance of electronic records. Comments on "Part 11, Electronic Records; Electronic Signatures—Scope and Application" are due by April 28. CHPA contact: Fred Razzaghi |
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FDA establishes public docket for cGMPs FDA announced in the February 27 Federal Register that it has created a public document for information pertaining to its pharmaceutical current Good Manufacturing Practice (cGMP) initiative. The Agency stated its intention to ensure that all information submitted to FDA on the cGMP initiative regarding a risk-based approach to the regulation of drug manufacturing and product quality is available to the public in an expeditious manner. CHPA contact: Fred Razzaghi |
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Bayer's Gary Balkema to chair WSMI
CHPA contact: David Spangler |
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Staff travel inside the Beltway and beyond Donna Edenhart, director of public affairs, and Mimi Pappas, public affairs associate, traveled to FDA's Parklawn office to meet with Agency staff February 25 on a variety of potential consumer education initiatives. The two Public Affairs staffers also were CHPA's representatives at the National Consumer League's two-day consumer health forum February 27-28 at the National Press Club. . . Dr. Bill Soller, senior vice president and director of scientific and regulatory affairs, was among the presenters at the hemiquinquennial conference of the United States Pharmacopeial Convention, Inc. (USP) in Phoenix, Arizona (see related story). . . Fred Razzaghi, director, technical affairs, and Dr. Lorna Totman, senior director of scientific affairs and toxicology, attended FDA's small business town meeting for the pharmaceutical industry in Philadelphia March 5 (see related story). . . On March 6, Kevin Kraushaar, vice president and director of government relations attended the U.S. House Appropriations Subcommittee on Agriculture hearing on FDA's 2004 budget (see related story). . . |
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GlaxoSmithKline's Cathy Sohn named HBA's 2003 "Woman of the Year"
During her 20-year career with GSK (formerly SmithKline Beecham), Sohn has held a number of positions involving their pharmaceutical business such as medical affairs, business development, and strategic alliances. In her current role in Consumer Healthcare, she is responsible for licensing, acquisitions, and partnerships as sources of growth for the global business. An active member of CHPA, Sohn is the current chair of the Association's International Affairs Committee and an ex officio member of the Board of Directors. Sohn also serves on the board of the World Self-Medication Industry. |
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CFH offers telephone emergency stickers for National Poison Prevention Week The Council on Family Health (CFH) is offering red and white emergency telephone stickers free to consumers during National Poison Prevention Week, March 16-22. The boldly colored peel-and-stick labels bear the nationwide poison control hotline number—1-800-222-1222—and can be affixed to a phone, the refrigerator, or a wall for easy access. They also provide space for the numbers of a family doctor and the local pharmacy.
"Prevention is paramount when it comes to accidental poisonings around the home," said CFH President Robert G. Donovan. The Council—a nonprofit education organization promoting responsible medicine use—recommends a number of easy but vital steps that Americans can take to help safeguard their families against accidental medicine poisonings. They include using child-resistant packaging, keeping medicines and dietary supplements out of the sight and reach of children, and knowing what to do in an emergency. Continued Donovan: "In the case of any accidental poisoning, getting professional help immediately is critical. Having the telephone numbers to medical professionals in plain sight could save a life." CFH’s emergency telephone stickers (two per household) are available at no charge year-round by sending a self-addressed, stamped envelope to: Council on Family Health, "Emergency Stickers," 1150 Connecticut Avenue, NW, Suite 1200-B, Washington, DC 20036. Companies and organizations may order bulk quantities (up to 50) on CFH’s web site at www.cfhinfo.org. |
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Posters available from Poison Prevention Week Council The Poison Prevention Week Council created posters for the observance of National Poison Prevention Week, March 16-22. The 11" x 17" black-and-white artwork is available to the public and may be purchased from Poison Prevention Week Council, P.O. Box 1543, Washington, D.C. 20013. The posters are available in quantities of 25 at a cost of $10.00, 50 copies at $18.00, and 100 copies at $32.00. Payment must accompany poster orders.
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Dickinson appointed president of CRN The Council for Responsible Nutrition's (CRN's) board of directors voted to make permanent the previously temporary role of Annette Dickinson, Ph.D., as the head of the dietary supplement trade association. Dickinson was officially named CRN's president February 27 after serving as the organization's acting president since January 2 (see January 10 XNL). |
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FDA's McClellan to keynote PQRI conference FDA Commission Mark B. McClellan, M.D., Ph.D., will provide the opening remarks at the Product Quality Research Institute's (PQRI's) April 3-4 conference in Arlington, Virginia. The conference program, dubbed Good Regulation Through Good Science, includes an array of other expert speakers representing academia, government, and industry. In addition to the special appearance by the commissioner of FDA, day one of the event also includes four PQRI breakout committee sessions hosted by members of the drug substance, drug product , biopharmaceutics, and manufacturing technical committees. Day two features a morning address by Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA, and several panel discussions on PQRI's prospects for the future. 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 burdens through sound science. CHPA is one of the founding member organizations and serves on its steering committee. For more information about PQRI, visit www.pqri.org. |
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FDA/Industry Summer Workshop
FDA/Industry Summer Workshop
FDA/Industry Summer Workshop
CHPA
MarketPlace
Manufacturing Controls
Seminar
Research
& Scientific Development Conference
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| Executive Newsletter is published every other week by the Consumer Healthcare Products Association |
| 1150 Connecticut Avenue, NW, Suite 1200, Washington, DC 20036 |
| Tel: (202) 429-9260 |
| Fax: (202) 223-6835 |
| Web site: www.chpa-info.org |
| Forward contact information changes to CHPA's Membership Department. |
| Forward editorial comments or questions to CHPA's Public Affairs Department. |
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| Copyright © 2003 by the Consumer Healthcare Products Association (CHPA). CHPA's Executive Newsletter is for general information purposes only. Information reported in this newsletter is compiled from various sources. All efforts are made to assure the accuracy of the content, but CHPA cannot guarantee the information. | |
| http://www.chpa-info.org | |
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