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March 21, 2003 |
No. 6-03 |
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CONTENTS FDA proposes bar code regulation for drugs CHPA elects board and officers at AEC Hayes named chairman-elect of CHPA CHPA welcomes the newest members of the Association AEC 2003 sets the pace for a new kind of annual meeting General session speakers provide a wealth of information Breakfast session speakers go head-to-head Speakers at concurrent sessions take on DTC ads, FDA regulations, and multicultural marketing FDA to seek input on risk management activities Agency updates its how-to handbook on effective collaborations FDA launches comprehensive campaign to reduce medication errors CHPA staff travel inside the Beltway and beyond Poison prevention gains momentum CFH and FDA urge parents to read labels, pay attention to medicine ingredients Hispanic families now have health info at their fingertips 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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FDA proposes bar code regulation for drugs Certain OTC products will require bar codes containing the drugs’ National Drug Code (NDC) in a number of years, if FDA finalizes a proposed rule published March 14. According to the proposal—supported by CHPA—OTCs dispensed pursuant to an order and commonly used in hospitals would be required to provide bar-coded NDCs to reduce preventable adverse drug events associated with medication errors. The rule as proposed also would apply to all Rx drugs (except physician samples), biological products, and vaccines. The proposal would require the bar code to appear on the drugs’ labels: immediate containers, outside containers, and individually packaged tablets if they have unique NDC numbers. The use of bar codes is intended to improve patient safety by enabling health professionals "to verify that the right drug in the right dose in the right route of administration is being dispensed to the right patient at the right time," according to FDA. ___________________ FDA
expects bar coding to result in over 413,000 fewer adverse drug events
over the course of 20 years. FDA’s proposal to include only those OTCs that are used by
prescription and commonly used in hospitals is a result of comments the
Agency received, including those from CHPA. The Association argued in a
submission
filed July 26, 2002, that bar codes other than universal product codes on
retail packages for OTCs used in consumer settings would not add value nor
contribute to patient safety. (See August
2, 2002, XNL.) "Labeling," CHPA President Linda A.
Suydam, D.P.A., stressed following the publication of the proposal,
"is still the most appropriate tool to prevent medication errors
among consumers who use OTC products."
FDA intends to issue a final rule on the matter this year, following review of comments it receives during the 90-day comment period. The Agency has determined that drug manufacturers, repackers, relabelers, and private label distributors of OTCs subject to the rule—less than 10 percent of OTCs, or 9,800 packages, according to FDA estimates—will have three years following publication of a final rule to use up existing labels and make new labels bearing the bar codes. CHPA will comment on particular aspects of the rule to assure it maintains efficiencies in OTC distribution. CHPA contact: David Spangler |
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CHPA elects board and officers at AEC Directors and officers of CHPA were elected March 15 during the Association’s Annual Executive Conference (AEC). Richard K. Green, president and chief operating officer, Blistex Inc., was reelected CHPA chairman. Timothy G. Hayes, senior vice president & region head, North America, Consumer Care Division, Bayer HealthCare LLC, was named chairman-elect. Charles J. Hinkaty, president, Del Pharmaceuticals, Inc., was reelected immediate past chairman. Elected to CHPA’s Board of Directors for the first time were:
Reelected to the CHPA Board of Directors were:
Returning to the CHPA board were:
Elected as vice chairmen to the CHPA Executive Committee for the first time were:
Reelected as vice chairmen to the CHPA Executive Committee were:
Reelected as honorary vice chairman was:
CHPA contacts: Roman Blazauskas and Virginia Cox |
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Hayes named chairman-elect of CHPA Bayer senior VP, region head slated to lead trade association
Hayes has been active within the industry trade group’s leadership for a number of years. He was first elected to the Association’s Board of Directors in 2000. He also was appointed to CHPA’s Executive Committee and named chairman of the Association’s Finance Committee the same year. He became a vice chairman of CHPA in 2001. "Tim Hayes is such an asset to the self-care industry and to the Association," said CHPA President Linda A. Suydam, D.P.A. "His expertise will be invaluable as CHPA examines how today’s consumers and the healthcare system benefit from quality over-the-counter medicines and nutritional supplements." Hayes joined the Bayer Consumer Care Division in 1992, bringing with him 12 years of experience in the consumer products business at The Quaker Oats Company. Since then, he has held positions of increasing responsibility in Bayer Consumer Care trade marketing, sales, and strategic business management, serving most recently as senior vice president, Consumer Care U.S.A. In his current position, Hayes is responsible for Bayer’s over-the-counter medicine and dietary supplements businesses in the United States and Canada. Hayes is a member of the National Association of Chain Drug Stores Advisory Board. In 1998 and 1999, he chaired the American Heart Association Morris County American Heart Walk, which led the state of New Jersey in funds raised. Hayes received his degree in business and marketing from Furman University in South Carolina. He resides in New Jersey with his wife and three sons. CHPA contacts: Roman Blazauskas and Virginia Cox |
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CHPA welcomes the newest members of the Association The CHPA Board of Directors elected four Active and 11 Associate members March 15 at the 2003 Annual Executive Conference. For more detailed information concerning any of these companies, contact Phyllis Taylor in the CHPA Member Services department. Active members: ACCESS PRODUCT MARKETING, Alpharetta, Georgia; Robert T. Guest, president, will be the Official Representative (OR). Access manufactures Dex 4 and private label glucose tablets for use by diabetics. McLANE COMPANY, INC., Temple, Texas; Kimberly A. Woodard, manager, governmental affairs & corporate communications, will be the OR. McLane manufactures the Consumer Value Products brand of OTC products, sold predominantly through convenience stores. MECHANICAL SERVANTS, INC., Melrose Park, Illinois; Edward Edick, vice president, chief operating officer, will be the OR. The nature of Mechanical Servants’ business is the secondary repackaging of nonprescription drugs, sundries, and health and beauty care items into single-portion, instant-use, convenience sizes. RESICAL, INC., Orchard Park, New York; D. Brooks Cole, president, will be the OR. ResiCal produces Calmol4 Hemorrhoidal Suppositories and Resinol Medicated Ointment. Cole was previously active in CHPA while with The Mentholatum Company, Enamelon, and U.S. Dermatologics, and was a member of the CHPA Board of Directors. Associate members: STEPHEN-BRADFORD SEARCH, New York, New York [individual consultant]; Stacey Mann, director, will be the OR. The company is an executive search firm specializing in the OTC/pharmaceutical industries. Its areas of expertise include brand, strategic, promotion, consumer and trade marketing, market research, consumer affairs, and sales and business development. BUCHANAN INGERSOLL P.C., New York, New York [specialized service]; Sharon Blinkoff will be the OR. Buchanan Ingersoll is a full-service law firm with more than 350 attorneys in 14 offices throughout the United States and Europe. The firm offers legal services to clients from private entrepreneurs to publicly held, multinational conglomerates. The firm has an active food and drug law practice that provides legal counsel on the full range of issues for FDA-regulated products in the U.S. and the European Union. BURDOCK GROUP, Vero Beach, Florida [individual consultant]; Michelle Kantzler, business development, will be the OR. Burdock Group offers consulting on the launch and maintenance of product line extensions. In addition, the company works with FDA in a variety of applications including risk and safety assessment and efficacy assessment for claims substantiation. It also performs investigations, literature searches, and work on regulatory and toxicology issues. EXEL, Mechanicsburg, Pennsylvania [specialized service (logistics company)]; Mark W. Richards, senior vice president, development & account management, Americas, will be the OR. Exel is an integrated third-party logistics supplier to the consumer packaged goods industry. HAMACHER RESOURCE GROUP, Milwaukee, Wisconsin [specialized service]; David Wendland, vice president, will be the OR. Hamacher provides marketing services and retail business intelligence to manufacturers, retailers, and distributors within the healthcare industry. It also provides services in the areas of design, development, and deployment of retail marketing and merchandising expertise on behalf of retail drugstores, working with clients to increase sales and boost the productivity of retail space. HAYES REILLY ASSOCIATES, LLC, Morristown, New Jersey [individual consultant]; Hayes Reilly will be the OR. This consultancy is a boutique retained executive search firm, focusing on the consumer products and healthcare industries. Its specialty is placing professionals at the director level and above. TRANSLOCAL HEALTH CORPORATION, Springhouse, Pennsylvania [Internet service, print media, specialized service]; Kenneth Freirich, chief executive officer, will be the OR. TransLocal licenses in-depth, objective, disease- and condition-specific, preventive health information from Johns Hopkins to the healthcare industry that is translated and localized for populations in the U.S. and major markets around the world. It provides unbiased, third-party information to both OTC and prescription manufacturers and their customers and patients. Freirich was previously with IntelliHealth. TRICORBRAUN, St. Louis, Missouri [packager]; Keith Strope, president & chief executive officer, will be the OR. TricorBraun is a supplier of glass and plastic containers, closures, dispensers, and tubes, representing most major container and closure manufacturers in the United States and maintaining several strategic supplier relationships in Europe and the Pacific Rim. The company has 27 branch locations in the U.S. and Canada alone. It develops new package designs in both glass and plastics, and serves as a stocking distributor of closures, pumps, sprayers, pharmaceutical cotton and rayon coil, and other ancillary packaging components. UNIGEN PHARMACEUTICALS, INC., Broomfield, Colorado [supplier, testing & research service]; Derek H. Hall, president & chief executive officer, will be the OR. Unigen is a research and development company that discovers proprietary ingredients from natural sources utilizing pharmaceutical research standards. UPS SUPPLY CHAIN SOLUTIONS, Alpharetta, Georgia [specialized service (logistics company)]; Duane Sizemore, vice president, healthcare, will be the OR. UPS Supply Chain Solutions has brought together a portfolio of services to get products to market faster and for less cost, accelerate cash flows, minimize inventory, and consolidate the complex network of providers required to compete in a global marketplace. From multi-modal transport and freight forwarding to customs clearance and international trade and logistics consulting, UPS can design facilities, handle distribution, manage inventory and returns, insure cargo, move goods and information and funds, and reduce mailing costs, thereby streamlining the overall supply chain. USF PROCESSORS, division of USF Logistics, Dallas, Texas [specialized service (logistics company)]; Harold Anderson, executive vice president-business development, will be the OR. USF Logistics is a fully integrated logistics company offering a full complement of services to the healthcare industry. USF Processors specializes in reverse logistics. CHPA contact: Phyllis Taylor |
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AEC 2003 sets the pace for a new kind of annual meeting
CHPA President Suydam (left) and CHPA Chairman Green (right) thank AEC Business Program Committee Chairman Patrick M. Lonergan (center), partner, president, NUMARK Laboratories, and his committee of volunteers for two information-packed and entertaining days at AEC 2003. CHPA’s 2003 Annual Executive Conference (AEC) has now become a chapter in the Association’s history book. If you were not among the 300-plus attendees at Turnberry Isle in Aventura, Florida, however, you may be wondering how the debut of the "new and improved AEC" went. While the conference was a day lighter in time, the business program was much heavier in content. Or, as CHPA Chairman Richard K. Green, president and chief operating officer, Blistex Inc., remarked during the meeting: "We have to squeeze 10 pounds in a five-pound bag." Members who were able to join us at The Turnberry have had a few days to reflect on their own personal experiences. The following stories provide a synopsis of events for the rest of you to draw your own conclusions. |
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General session speakers provide a wealth of information Green and Suydam speak to members on priorities, emergent issues
CHPA’s Chairman Richard K. Green (center), president and chief operating officer, Blistex Inc., and President Linda A. Suydam, D.P.A.(left), spoke to the Association’s membership in a Q&A session at the Second General Session of the AEC. Moderating the event was Catherine A. Sohn, Pharm.D.(right), vice president, worldwide business development, GlaxoSmithKline Consumer Healthcare Worldwide. Because this was the first AEC at which Green and Suydam officially presided in their respective roles as chairman and president of the Association, each was asked to reflect on the past months and to talk briefly about some of CHPA’s new initiatives. _______________ "I
think we really challenged ourselves this year and I have had great
support from an excellent Executive Committee and Board of
Directors." Sohn then asked Suydam to reiterate the Association’s priorities. "At last year’s annual meeting, the board identified five top priorities for the Association," she replied. "The first is enhancing relationships with FDA. The second is developing and promoting the benefits of OTCs and dietary supplement products in the overall healthcare system. The third is building the environment for Rx-to-OTC switch, something that Dr. McClellan touched on yesterday. [See related story.] The fourth is shaping and applying risk management principles on both ingredient and manufacturing issues. And the fifth is representing members’ interests on a variety of ingredient issues at both the state and federal levels." In response to a follow-up question, Suydam elaborated on how CHPA has been working with FDA. In addition to pointing out that the Agency has participated in a number of CHPA meetings, including the AEC, Suydam touched on a new program currently being developed: joint educational modules. "We have received a very positive response from FDA on the first session which will be held in May on labeling, specifically creation and implementation," Suydam informed members. Some of the other issues Green and Suydam addressed were the Association’s support of OTCs as tax deductible expenses, recent CHPA efforts in the states, what FDA’s newly released proposal on dietary supplement Good Manufacturing Practices means to the industry, and FDA’s proposed rule on bar coding for medications dispensed in single-unit packaging (See lead story). Green expanded on the issue of bar coding for the audience. "Because OTCs are used in hospitals," said Green, "CHPA has participated in FDA meetings on the subject and is preparing comments presenting the industry’s perspective on the proposed rule . . . We want to help provide suggestions to FDA on how to move forward in a practical and cost-efficient way." For a more complete review of Green and Suydam’s Q&A session, click here.FDA Commissioner Mark McClellan addresses the CHPA membership
The majority of McClellan’s comments focused on the Agency’s big picture priorities with respect to medicines, including OTCs, and the role they play in the overall healthcare system. "We need to provide the American public with the best health while avoiding heavy expenses," said McClellan. "We need to make sure that consumers have more options and lower costs and OTCs are very important in this process." |
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________ "The
OTC drug market is extremely important to promoting the health of the
public." |
McClellan stressed that FDA’s regulations and policies must be of a high standard, but cost-effective. "We are in the business of getting the most bang for the healthcare consumer buck," he said. The commissioner cited the goal of reducing preventable adverse events as one of the Agency’s top priorities. He stated that FDA was tackling this issue by using a three-pronged approach. The first piece of the process he mentioned was the Agency’s issuance of a proposed rule on bar coding for medicines, including OTCs, used in institutional settings. McClellan explained, "We think that this initiative can prevent up to 50 percent of medication errors." The second component the commissioner referred to was the Agency’s announcement of a new approach for international standards that is more risk-based for the collection of safety information. And the third and final piece McClellan said the Agency is aiming for is automatic reporting for adverse events. |
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In addition to covering drug-related topics during his remarks, the commissioner touched briefly on the area of dietary supplements, specifically the release of the Agency’s long-awaited proposed rule on Good Manufacturing Practices (GMPs). He said that FDA expects to finalize the rule sometime next year and that GMPs will greatly improve the quality of the dietary supplement market overall. Buckingham dispels myths about happy workers
According to Buckingham, good managers look for specific talents in individual staff members and then encourage the development of that talent. He stressed the importance of remembering, however, that there is a distinct difference between a talent and a skill. "If trained properly, an employee may be capable of learning a particular job, but it doesn’t necessarily mean that there is an inherent talent at play," he explained. Perhaps the most surprising information that Buckingham relayed during his presentation was with respect to employee engagement on the job. He said that employees are the most engaged during the first year of employment and that "the longer employees stay with an organization, the less engaged they become." Even more distressing, Buckingham shared the results of a recent survey that found that up to 70 percent of Americans are currently unengaged in their jobs. What’s so funny about healthcare economics?
Guests at The Turnberry who walked past the Second General Session room sign billing economist Uwe E. Reinhardt, Ph.D., as a speaker must have been curious when they heard fits of laughter emanating from behind the closed doors of the ballroom. But if you were fortunate enough to have been among the AEC attendees, you witnessed first-hand that session speaker Reinhardt not only has a gift for economics, but a tremendous sense of humor, as well. In between his engaging jokes and witticisms, however, he managed to sneak in a truckload of useful information. According to this professor of economics who hails from Princeton University, the healthcare gross domestic product (GDP) in the United States isn’t in as bad a shape as some might think. "[The Centers for Medicare & Medicaid Services] predicts we will be spending 17 percent of the GPD in 2011 on healthcare," he said. "Can we afford the 17 percent?" he asked. "The answer is yes," according to the economist, "because the non-health GDP will be considerably larger." Reinhardt furthered this point by adding that "healthcare economists will tell you that hospitals drive the health spending, not the drug prices." Reinhardt continued his presentation by explaining that American consumers do not like to make trade-offs between healthcare and other things of value. "They’d rather sacrifice education than healthcare," he said. "Most other nations are willing to ration healthcare somewhat for the sake of other things." Regarding OTC products and how they fit in the overall healthcare system, Reinhardt suggested that health insurers pick up the tab for consumers, particularly for products that make the switch from prescription status. "OTCs are a God-send to [consumers]," he explained, "because they can access [nonprescription medicines] without having to make a side payment to a physician." Wal-Mart executive shares retail merchandising strategies
David Pinto (right), editor, Chain Drug Review, moderated a special one-on-one conversation with Douglas Degn (left), executive vice president, food and consumables merchandising, Wal-Mart Stores, Inc., at the First General Session of the AEC. Degn entertained members by showing both his and Wal-Mart’s sense of humor by opening with a Saturday Night Live clip that poked fun at the massive size of the retail giant. When Pinto asked Degn to discuss how Wal-Mart determines what merchandise to stock in which locations, Degn replied: "Why do they sell umbrellas in Seattle?" He revealed that Wal-Mart strongly factors in the demographics for each store in an attempt to tailor the products to stock for each specific market. As far as Wal-Mart’s famous low-pricing strategy, Degn said that the retailer tries to cater to those American consumers who live paycheck to paycheck. |
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Breakfast session speakers go head-to-head Barnicle warns of the necessary evils of media "Too many people believe that the gossip they hear on 24-hour cable news channels is the real news," said political commentator Mike Barnicle at the Hearst Magazines-sponsored breakfast session of the AEC. "The Internet, talk-radio programming, and 24-hour cable news is potentially good in the long range," he offered, "but do we actually really think about the content?" Barnicle provided his own unique and often cynical opinion on the influence of the media on today’s society. Citing the recent coverage of the return of missing teenager Elizabeth Smart, Barnicle credited the media for playing a key role in finding her. "After searching for her for nine months, it only took about 12 minutes to find her after the media aired the lead," he said. "Unfortunately, the same media that helped bring her home will ruin her and her family in the next few weeks by asking questions like, ‘Why didn’t you run?’" Barnicle then turned his attention to politics and pointed at cable news television as being partially responsible for the conflict between the Republican and Democratic parties. "Years ago, the two parties may have had differences, but they got along too because they spent time together. Today," he went on to conclude, "they don’t even bother. They go head to head on cable television."
Tucker Carlson talks about the "nice" Congress, the president, and war In almost classic Crossfire fashion, political columnist Tucker Carlson totally contradicted Mike Barnicle’s views on the Republican and Democratic parties. (See previous story.) "There are few mean people in Congress anymore," said Carlson. "People just will not put up with bad manners." While these liberal comments were surprisingly uncharacteristic of this usually sharp-tongued conservative, Carlson explained to attendees of the Reader’s Digest Breakfast Session that the tragedy of September 11 has made politics much less predictable. Carlson went on to say that because the American public "likes the federal government more than it ever has," the type of debating done shifts on Capitol Hill. He used the topic of prescription drug benefits as an example of this political change, stating that "it’s not a question of whether the government should be involved, it’s how big the benefit should be." In a more Tuckeresque style, Carlson staunchly defended President George W. Bush, calling him "an extremely effective leader." He said that political figures in America today must be able to speak the language of both parties in order to succeed. "If you listen closely," Carlson suggested, "you will notice that every one of Bush’s speeches starts out with liberal issues, but then he throws in kernels of conservatism." And on the issue of war, Carlson said that it was "absurd" for people to believe that the war is for oil. "In my opinion, Bush is pushing this war because he believes in it." |
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Speakers at concurrent sessions focus on DTC ads, FDA regulations, and multicultural marketing DTC advertising session: Ads hold promise for the OTC marketer
CHPA members attending the direct-to-consumer (DTC) advertising concurrent session gained valuable insights into how to capitalize on the changes in professional and consumer attitudes toward OTCs created by DTC ads. The expert panel consisted of Robert C. Burruss, executive vice president, managing partner, Grey Worldwide, Inc.; Edwin P. Slaughter, corporate director, market research and library services, Rodale, Inc.; and Edward C. Kuehnle, group president, North America, Information Resources, Inc. Burruss told attendees that "DTC has a market-conditioning effect on the OTC consumer, which can help OTC products in the same category." Consumers become more informed, more involved, and more competent to self-treat and self-diagnose as a result. Not only are consumers likely to talk to their doctors about medicines they’ve heard about through DTC, says Burruss, but compliance rates also are higher for these medications. Burruss suggested that OTC marketers can capitalize on the effects of DTC by performing clinical trials that compare their products to the Rx brands, marketing OTCs more to doctors, and exploiting the advantages OTCs offer over prescription drugs. In his comments, Slaughter stated that DTC advertising has caused the healthcare market to evolve into a self-care market. DTC advertising has created an "empowerment loop": Consumers see an ad, ask for the advertised drug, and become more vested in the outcome. Additionally, Slaughter pointed out, continued marketing serves as a reminder to keep taking the product. Even though research indicates that 13 percent of consumers, or 26 million people, have switched from an OTC to an Rx medicine because of DTC advertising, overall, the use of OTC products increases along with Rx use. DTC also may prepare consumers for eventual self-treatment of chronic conditions with OTC switch medications, according to Slaughter. _______________ DTC
advertising has created a consumer
"empowerment loop." Kuehnle expanded on the concomitant-use consumer. He encouraged attendees to think about the OTC consumer, the Rx patient, and the retail customer as one individual. The pharmaceutical market is a complex interaction of product categories and distribution channels, and the majority of consumers view DTC ads as informative, making them want to learn more about the products, he suggested. "Understanding concomitant users and how they perceive DTC ads," Kuehnle summed up, "is important to better marketing of OTCs." FDA perspectives session: How the Agency regulates OTCs
Switch The dynamic nature of the current switch process was at the heart of Kweder's discourse on the subject. While she noted that application for switch is usually made by a new drug application (NDA) sponsor, she pointed out that this area is changing and that more third parties may submit Citizen Petitions in the future. She also intimated that FDA may initiate the switch process in the future, but stressed that an application by anyone other than the original sponsor would be very resource intensive for the Agency. She admitted that perhaps the Agency has not done a good job of defining the standards for Rx-to-OTC switch and that the OTC division was looking into setting forth guidance on such standards. She also stated that safety is the first concern for a product going over the counter and effectiveness is second. Kweder suggested workshops would be helpful in shaping a framework for future switches involving more challenging issues. Labeling and innovation While Kweder conceded that initial feedback on the Drug Facts label has been very positive, she told concurrent session attendees that the Agency is still evaluating its effectiveness as a risk management tool. She also talked about the future trends in the OTC arena and challenged the group to explore more innovations in the interest of public health, focusing on chronic conditions, new technology, and improved adverse event reporting. She stated that the biggest obstacle to OTC development is predicting and influencing consumer behavior. Hispanic marketing session: Marketing to the Latino community is becoming mainstream
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General
sessions, breakfast sessions, luncheons, dinners, receptions, the
hospitality lounge, scholarships, the fun run,
AEC goodie bags and prizes, sports competitions (Click
here to see who won the events), the Sports Night...
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Forty tables have already been reserved. |
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Legal reform passes House The U.S. House of Representatives passed HR 5—the Health, Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003—by a vote of 229-196 March 13. While most of the bill provides healthcare litigation reform to deal with the skyrocketing cost of medical malpractice insurance premiums, the bill also includes a Government Standards Defense (GSD) for medical products regulated by FDA. If enacted, it would provide a defense against punitive damages for drug manufacturers that comply with government standards, absent proof of fraud or malfeasance. The bill has been received in the Senate, where it is expected to be referred to the Health, Education, Labor, and Pensions Committee. The Senate is expected to draft its own bill for consideration by committee in April. Working with Energy and Commerce committee staff, CHPA was successful in getting report language included to ensure that OTC drugs marketed pursuant to both final and tentative final monographs are covered by the GSD provision. CHPA contact: Kevin Kraushaar |
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FDA to seek input on risk management activities The Agency announced March 7 that it will conduct a public workshop on risk management activities for drug and biological products. FDA will use the April 9-11 workshop as an initial step in producing guidance for industry on the subject. Each day of the three-day workshop will focus on a separate aspect of the Agency's risk management programs.
FDA working groups have already produced concept papers outlining the Agency’s opinions on the above topics. The workshop will be held at the National Transportation Safety Board Boardroom and Conference Center in Washington, D.C. For more information on the workshop and to review the concept papers, click here.CHPA contact: Dr. Lorna Totman |
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Science Board to meet The March 18 Federal Register announced an upcoming public meeting of FDA’s Science Board. The meeting will take place April 9, from 8:00 a.m. to 4:30 p.m., in Rockville, Maryland. Included on the agenda is a status update on the pharmaceutical manufacturing initiative. Persons wishing to submit written comments or requesting to make oral presentations at the meeting should contact FDA’s Susan Bond by March 28. |
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Agency updates its how-to handbook on effective collaborations Recognizing the importance of collaborating with industries it regulates, academia, and consumers, FDA has updated its Leveraging Handbook for staff. The manual describes for FDAers the purpose of leveraging and how it can be used to help the Agency effectively and efficiently accomplish its mission to protect and promote the public health. The handbook helps explain the steps FDA staff need to take to enter into leveraging agreements, provides an overview of leveraging mechanisms, lays out legal and ethical points staff need to consider, and describes the internal review and sign-off process at the Agency. |
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FDA launches comprehensive campaign to reduce medication errors The Agency published reams of paper March 14, proposing new rules designed to improve patient safety by reducing preventable adverse events associated with drug and biologic products. The first concerned bar coding. (See lead story.) A second proposed rule describes amendments to pre- and postmarketing safety reporting regulations for drugs under new and abbreviated new drug applications. The proposal seeks to both improve the quality and usefulness of safety reports submitted to the Agency as well as to facilitate the consistency of safety reporting around the world. |
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CHPA staff travel inside the Beltway and beyond CHPA President Linda Suydam, Vice President and Director of Government Relations Kevin Kraushaar, and other Association staff attended the Women's Policy Inc. Congressional Dinner March 19 honoring new women members of the 108th Congress. Suydam and Kraushaar also attended a special VIP reception with select congressional members prior to the dinner... |
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Poison prevention gains momentum The benefits of child-resistant packaging were touted at the March 10 press conference announcing National Poison Prevention Week. "Using child-resistant packaging is certainly one of the most effective ways to save children’s lives," said Hal Stratton, chairman of the U.S. Consumer Product Safety Commission (CPSC), in remarks at the Bethesda, Maryland, press conference. CPSC has required child-resistant packaging on 30 different substances since 1972. Members of the Poison Prevention Week Council—including CHPA—were on hand at the press conference to help CPSC and the American Association of Poison Control Centers raise public awareness to the issue of accidental poisonings in the home. According to Peter G. Mayberry, chairman of the council, "There continue to be upwards of a million poison exposures involving small children each year." The council recommends that household products that may harm small children be locked and stored out of children’s reach. And in the case of an accidental poisoning, the council reminds Americans that there is a toll-free, nationwide telephone number available that connects callers with their local poison control centers. That number is (800) 222-1222. The 42nd annual National Poison Prevention Week ends today. For more information about the Poison Prevention Week Council and the publications it offers consumers, visit its web site at www.poisonprevention.org. To order telephone stickers bearing the toll-free poison control number, visit the Council on Family Health at www.cfhinfo.org.CHPA contact: Dr. Lorna Totman |
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FDA to conduct cGMP workshop FDA and the Product Quality Research Initiative, or PQRI, have announced a joint educational offering, "A Drug Quality System for the 21st Century." The workshop will take place April 22-24 in Washington, D.C. The public workshop is designed to present an overview of FDA activities and assessments on risk-based current Good Manufacturing Practices (cGMPs), integrated quality systems, changes without prior approval, and manufacturing science. The full agenda and registration details are posted online. |
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Hispanic families now have health info at their fingertips The U.S. Department of Health and Human Services (HHS) and the National Alliance for Hispanic Health announced the creation of a new, bilingual resource for Hispanics: the toll-free "Su Familia" National Hispanic Family Health Helpline. By calling (866) SU-FAMILIA, Hispanics can receive basic health information to help them prevent and manage chronic conditions, as well as information on local health providers and federally supported programs. The resource is part of HHS’s initiative to eliminate health disparities. For more information, visit the National Alliance for Hispanic Health online under "resources." |
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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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| 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. | |
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Timothy
G. Hayes, senior vice president and region head, North America,
Consumer Care Division, Bayer HealthCare LLC, was named chairman-elect of
CHPA by the Association’s Board of Directors at CHPA’s Annual
Executive Conference March 15. (See previous story.) Hayes will succeed the current chairman, Richard
K. Green, president and chief operating officer, Blistex Inc., in
2004.
