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The catalog, training materials, schedule and on-line registration can be found under Training at http://oitweb/.
FDA on Dec. 21 proposed a new format for prescription drug labeling that will help reduce medical errors, which according to the National Academy of Sciences may be responsible for as many as 98,000 U.S. deaths annually. FDA believes that this new, user-friendly format will reduce errors in drug prescribing.
"Today's proposal is FDA's latest initiative to improve the labeling of the products it regulates," said FDA Commissioner Jane E. Henney, M.D. "This proposal is particularly valuable because it will make important information available in a clear, consistent and readable format that is essential to proper prescribing practices."
Prescription drug product labeling, also known as the package insert, represents a primary means of providing critical information about drugs to practitioners. As part of the drug review process, FDA reviews and approves drug product labeling that is initially proposed by manufacturers.
An FDA study showed that practitioners found drug product labeling to be lengthy, complex and hard to use. The proposed new format would provide user-friendly labeling that would allow practitioners to quickly find the most important information about the product.
One major change is inclusion of a new introductory "Highlights" section of bulleted prescribing information. This section would include the information that practitioners most commonly refer to and view as most important. It would provide the location of further details elsewhere in the labeling.
The proposed new labeling is expected to reduce practitioners' time spent looking for information, decrease the number of preventable medical errors and improve treatment effectiveness. The information will be easier to find, read and use.
Because these labeling revisions represent considerable effort and are most critical for newer and less familiar drugs, the proposal will apply only to relatively new prescription drug products.
Written comments are due to FDA by March 21. A copy of the proposed rule is available in HTML at http://www.fda.gov/ohrms/dockets/98fr/122200a.htm or in PDF at http://www.fda.gov/ohrms/dockets/98fr/122200a.pdf.
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FDA on Dec. 8 approved a new treatment for atopic dermatitis (eczema)-a non-contagious skin condition that can cause redness, itching and oozing lesions. The drug is tacrolimus (Protopic), an ointment for patients with moderate to severe eczema, for whom standard eczema therapies are deemed inadvisable because of potential risks, or who are not adequately treated by or who are intolerant of standard eczema therapies.
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On Nov. 28, FDA announced that Glaxo Wellcome, of Research Triangle Park, N.C., had informed the Agency that it would voluntarily withdraw alosetron (Lotronex) tablets from the market. Alosetron is a prescription medication approved to treat irritable bowel syndrome in women.
The company's action followed a meeting where the Agency discussed with Glaxo Wellcome risk management options that included restricting the distribution of the drug or marketing withdrawal.
The action followed FDA analyses of the post-marketing reports of serious adverse events, which included five reports of death in patients taking alosetron.
The Center's Lotronex information Web page (http://www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm) has more information, including a letter from the Center director to consumers.
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FDA on Nov. 15 announced approval of Trizivir for the treatment of HIV in adults and adolescents. Each dose of Trizivir is a fixed-dose combination of abacavir (Ziagen), zidovudine (Retrovir), and lamivudine (Epivir), three nucleoside reverse transcriptase inhibitors already approved by FDA. Because Trizivir combines a single dose of three drugs into one pill, it may be easier for some patients to comply with their medication regimen. Each component of Trizivir is also available separately.
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FDA on Nov. 6 announced it is taking steps that may lead to removal phenylpropanolamine from all drug products and has requested that all drug companies discontinue marketing products containing the ingredient.
FDA issued a public health advisory concerning the risk of hemorrhagic stroke, or bleeding into the brain, associated with phenylpropanolamine, an ingredient used in many over-the-counter and prescription cough and cold medications as a decongestant and in OTC weight loss products.
Adverse events reported with these products led to concerns that this ingredient might increase the risk of hemorrhagic strokes.
Manufacturers of products containing phenylpropanolamine worked with FDA to plan a research program to clarify whether any increase in risk exists.
Scientists at Yale University School of Medicine conducted the study in which the researchers found an association between phenylpropanolamine use and stroke in women.
The increased risk of hemorrhagic stroke was detected among women using the drug for weight control, and for nasal decongestion, in the three days after starting use of the medication. Men may also be at risk. FDA believes that although the risk of hemorrhagic stroke is very low, even with phenylpropanolamine use, the conditions for which these products are used do not appear to warrant an increased risk of this serious event.
Information about the history of phenylpropanolamine, the Public Health Advisory, and the stroke study results can be found at http://www.fda.gov/cder/drug/infopage/ppa/default.htm.
Immediately after the public health advisory, the Center experienced high public interest in the subject. About 1,000 telephone calls a day were received in the Division of Drug Information, said Barbara Daciek, a DDI consumer safety officer. The Center's phenylpropanolamine Web pages recorded about 250,000 hits in their first two days online, according to CDER webmaster Paul Stauffer.
By Jean Yager and Deborah Kallgren
When was the last time you attended a professional development program that kept your interest from start to finish? An event that involved you in the action instead of making you feel like a spectator in a room full of talking heads? An experience so chock full of useful information that you could take it back to your job and apply the ideas and concepts right away?
For a number of CDER and CBER project managers, just such an event for occurred this May at the third Joint Training Workshop on the Process of Pharmaceutical Drug Development and Review sponsored by FDA and the Drug Information Association. The two-and-a-half day training event was held in Bethesda for about 250 regulatory affairs and project management professionals from industry and FDA. They learned about each other's processes, identified factors critical to successful drug development and review and strengthened their skills as team players.
Keynote speakers were Center Director Janet Woodcock, M.D., and Senior Associate Commissioner Linda Suydam. Both underscored the importance of leveraging opportunities, such as the workshop, to improve FDA's regulatory and scientific knowledge base, reduce the risk involved with new drug and biologic products and better accomplish our shared goal of providing safe and effective drugs to the public.
Following these presentations, the program shifted into high gear with the introduction of "key factors." Thanks to the creative talents of the CDRH studio "wizards," a football film presented a parody of the new drug approval process called the "NDA Bowl." There were jabbering commentators, a charismatic quarterback, huddles, penalty flags, crazy commercials and a live mascot who moved in and out of the video to get the crowd into the game. Participants learned about the four key elements that facilitate good FDA-industry interactions: effective communication, adherence to commitments, meaningful information exchange and clarity of expectations. Important regulatory guidance was included in the script.
Next, industry and Agency attendees learned how to work together in the fast-paced teambuilding exercise, "Gold of the Desert Kings." Teams formulated and carried out plans to survive crossing a hostile desert environment in order to mine gold. The team mining the most gold and surviving the desert won. This portion of the workshop, more than any other, had folks on their feet, rolling up their sleeves and working together to achieve a common goal. There was the thrill of victory, and the agony of defeat was clearly shown by a stuffed vulture that appeared on a team table when survival was no longer an option. Participants learned that the key factors were pivotal in winning the game and the value of team collaboration couldn't have been clearer or more enjoyable.
A three-act play that followed described the roles of regulatory affairs professionals and project managers in a pharmaceutical company and those of a regulatory project manager in CDER. Three actors carried on parallel monologues as they moved through the three phases of drug development and the NDA review. They identified areas where industry and FDA needs were similar and areas where there were differences. The messages were easy to absorb. After each act, roving reporters actively engaged the audience in the discussion. This question-and-answer session was clearly a high point for focusing on lessons learned.
Later, real life case studies were presented in a fireside chat format. The actual industry and FDA regulatory officials who worked on the product development and review presented each case. Both negative and positive aspects were disclosed to maximize the learning experience.
The program closed as participants once again teamed up to work their way through a "virtual" drug development scenario. Each table was asked to pretend that they were the development team for a new product fraught with issues. Their mission was to create an interactive plan to address these problems proactively and bring in an approvable submission. This required that each team successfully apply information and learning gained from earlier portions of the workshop.
In concluding remarks, Mark Elengold, CBER Deputy Director, Operations, emphasized the need to continue to work hard at improving communications between Agency and industry teams as a means of meeting joint goals. Exit polls of workshop participants and evaluations submitted to the organizers gave the program very high marks and confirmed the usefulness of the data and the effectiveness of the dynamic and highly interactive format.
Plans are underway to hold another workshop in May 2002 that will include not only project management and regulatory professionals but also FDA and industry scientists from representative disciplines. The scope of the workshop will likely expand through the diversification of the audience. However, we guarantee the same highly informative, engaging and entertaining format.
Jean Yager heads and Deborah Kallgren is a member of the Center's Project Management Staff located in OTCOM.
Castles, Swords and Shields may sound like something from medieval times, but it's actually an innovative and dynamic training program designed to provide a way for CDER staff to test and improve their knowledge of drug regulations, guidances, policies, basic drug development and FDA history.
The first Castle, Swords and Shields game was piloted on Nov. 16. Participants were organized into four teams with four to five members in each team. The objective was to scale the game board's castle wall by answering regulatory and development topics correctly and earning points. A correct answer won a chip. The team with the most chips captures the flag and wins the game. Teamwork is vital as the subject matter can range from the relatively easy to the more demanding. Participants found that working closely to pool their knowledge paid off in chips.
Competitive interactions intensified during "lightening rounds" when teams challenged one another to win more chips. Approximately 18 project managers from across the Center with varying levels of experience took part in this pilot. The important information gained from their evaluations will be used to refine the game play and structure.
Frequently the time spent in training doesn't provide immediate returns on the job. The strength of the Castles, Swords and Shields is that it provides participants a stimulating and entertaining means to gain valuable regulatory knowledge, strengthen existing understanding and reinforce teamwork skills all at once. Based on the enthusiastic and encouraging feedback we received from our trainees, this program delivers.
The developers of this game were Tawni Brice, Rita Hoffman, Lisa Hubbard, Deborah Kallgren, Diane Moore, Matthew Tarosky and Jean Yager.
They would like to extend their appreciation to CDER staff who participated in this first premier of this training program: Julieann DuBeau, Walter Ellenberg, Laura Governale, Anna Marie Homonnay, Alice Kacuba, Dan Keravich, Crystal King, Melodi McNeil, Karen Oliver, Maureen Pelosi, Dianne Spillman, Brian Strongin, Leslie Vaccari, Melissa Truffa and Debra Vause.
--Jean Yager and Deborah Kallgren
By Tony Chite
Unscramble the letters below to spell a part of the human body.
1. -G-Y-A-A-A-D-M-L
2. -L-A-P-L-E-T-A
3. -R-E-U-B-E-M-C-R
4. -L-U-N-A
5. -S-I-I-R
6. -T-R-A-I-N-E
7. -M-U-J-J-N-E-U
8. -N-E-P-L-E-S
Answer key: 1.-amygdala; 2.-patella; 3.-cerebrum; 4.-ulna; 5.-iris; 6.-retina; 7.-jejunum; 8.-spleen.
Tony Chite is a pharmacist and CSO in CDER's DFOI.
By Jack Morin
CDER received the W. Edwards Deming Outstanding Training Award (above), because of its:
CDER's Competency Based Training Program provides an organized structure for career development. With the program, critical knowledge needed by staff is identified, prioritized and presented in a logical sequence. It also ensures that the content included in our courses, workshops and seminars focuses on the drug review process and related work requirements. This enables CDER staff to increase their productivity with a shorter learning curve. In addition, continuing education for experienced staff builds upon foundational knowledge and skills making more efficient use of Center resources.
Facilitated by the Division of Training and Development, the competencies and learning pathways were developed by the following CDER staff:
Tanya L. Abbott, Funmilayo O. Ajayi, Ph.D., Aisar H. Atrakchi, Ph.D., Dorothy C. Ballmann, Paula G. Bourkland, Heidi N. Burch, Sonia C. Castillo, Ph.D., Aloka G, Chakravarty, Ph.D., Tien-Mien Chen, Ph.D., Ling Chin, M.D., and Sandra L. Coffin.
E. Douglas Kramer, M.D., Philip M. Colangelo, Pharm.D., Ph.D., Eldridge F. Coles, Thomas A. Cunningham, Velma L. Cunningham, Joseph J. DeGeorge, Ph.D., Kuldeep R. Dhariwal, Ph.D., Angelica Dorantes, Ph.D., Patricia L. Downs, Amy L. Ellis, Ph.D., John L. Emelio, Jr., and Emmanuel O. Fadiran, Ph.D.
James G. Farrelly, Ph.D., Glenna G. Fitzgerald, Ph.D., Noreen A. Gomez, Alice L. Gray, Kenneth L. Hastings, Dr.P.H., Carol H. Hall, Anita G. Harrell, Devota D. Herbert, Karen M. Higgins, Sc.D., Robin A. Huff, Ph.D., Patricia F. Hughes, Ph.D., Patricia A. Johnson, Barbara M. Jones, Joyce Ann Korvick, M.D., E. Douglas Kramer, M.D., Kofi A. Kumi, Ph.D., and See-Yan Lam, Pharm.D., Ph.D.
Sheryl L. Lard-Whiteford, Ph.D., Sue-Chih Lee, Ph.D., Sally J. Lewis, Kooros Mahjoob, Ph.D., Iftekhar Mahmood, Ph.D., Maureen D. Majors, Frederic J. Marsik, Ph.D., Patrick J. Marroum, Ph.D., Jamie M. Metz, Veronica E. Milstead, Rebecca E. Nalley, Shriniwas G. Nerukar, Ph.D., Janice L. Newcomb, Peggy A. Noland, Carol T. Norwood, Susan H. O'Malley, William W. Oswald, Larry A. Ouderkirk, Dawn M. Reid, Charles A. Resnick, Ph.D., and Delores A. Rhodes.
Laura E. Riddle, Kathy A. Rios, Lawrence F. Sancilio, Ph.D., Wendelyn J. Schmidt, Ph.D., John R. Senior, M.D., Daniel A. Shames, M.D., Janice M. Sheehy, Barbara E. Shekitka, Albert T. Sheldon, Ph.D., Robert M. Shore, Pharm.D., Ronald W. Steigerwalt, Ph.D., He Sun, Ph.D., Vijaya K. Tammara, Ph.D., and Sandra Van Buskirk.
Victor H. Vail, Richard T. Vengazo, Vera K. Viehmann, Zakaria Wahba, Ph.D., Michelle L. Walling, Juandy S. Walston, Dan Wang, Ph.D., Andrea B. Weir, Ph.D., Karen R. Weller, Laura M. West, Leslie DeLaPena Wheelock, Grant A. Williams, M.D., Rosa L. Williams, Tonya R. Wise and Matthew A. Zell.
Also, about 600 CDER staff completed the training needs assessment, and more than 200 CDER staff participate in revising and developing courses annually.
Jack Morin is a writer-editor in DTD.
This is my favorite column of the year. I get to poke through all the back issues and find out just how busy CDER has been. I am always amazed at the large number of your friends and colleagues who took time from their busy schedules to share something important with you. We had contributions from a large cross-section of the Center, two student interns and two authors from outside CDER.
Here are the folks who contributed bylined articles in 2000:
Jackie Barber, R. Daniel Benz, Ph.D., Celeste Bové, Melissa Chapman, Mei-Ling Chen, Ph.D., Tony Chite, Yuan-yuan Chiu, Ph.D., Patrick Clarke, Bronwyn Collier, Joseph Contrera, Ph.D., Juliann DuBeau, Linda Emilio, Emmanuel Fadiran, Ph.D., Elaine Frost, Janet Gentry, and Mark Goldberger, M.D.
Erik Henrikson, Robin Huff, Ph.D., Shelly Johnson, Christine Kaibni, Deborah Kallgren, Lydia Velazquez Kieffer, Pharm.D., Kofi Kumi, Ph.D., Larry Lesko, Ph.D., David Lester, Ph.D., Sherunda Lister, Murray Lumpkin, M.D., Darek Maciasz, Nasser Mahmud, Edwin Matthews, Ph.D., Nanette McAtee, E. Jane McCarthy, Ph.D., Judy McIntyre, Edward Miracco, and Justina Molzon, M.S.Pharm., J.D.
Jim Morrison, Dave Moss, Sakti P. Mukherjee, M.D., D.Sc., Janice Newcomb, Chris Nguyen, Linda Papio, Maureen Pelosi, Judith Racoosin, M.D., MPH, C. Russ Rutledge, Arzu Selen, Ph.D., Tony Sims, Nancy Smith, Ph.D., John A. Spencer, Ph.D., Vaiyapuri Subramaniam, R.Ph., M.S., and Gloria Marquez Sundaresan.
The Communications Results Team, The RAC Representatives, Claudia R. Turner, Ph.D., Rajendra Uppoor, Ph.D., R.Ph., Debbie Werfel, Dale F. Wilcox, Ron Wilson, Janet Woodcock, M.D., Jean Yager, Robert Young and Karen Zawalick.
More work behind the scenes to help bring you the Pike by supplying information and checking facts.
Foremost among these are the people in the Office of Information Technology who team up to bring you their monthly column. They are:
Sheila Andrew, Greg Brolund, Melissa Chapman, Don Duggan, Peter Fabry, Janet Gentry, Mary Ann Holovac, Rich Johnson, Lana Kostecka, Ralph Lillie, Mark Magee, Tim Mahoney, Jim Marshall, Linda Sigg, Mike Simms, Vali Tschirgi, David Wardrop and Jayne Ware.
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World Aids Day was Dec. 1, and HHS always reminds us of the toll this disease takes. As of June 2000, AIDS had been reported among 753,907 persons in the United States, and 438,795 of these persons have died. An estimated 311,701 persons were reported to be living with AIDS. Although deaths from AIDS began to decline in 1996, primarily because of the use of effective combination antiretroviral therapy, AIDS deaths and AIDS incidence trends began to level by 1999. Since 1992, HIV incidence has been relatively stable. An estimated 40,000 new HIV infections are expected to occur each year. The number of persons living with HIV and AIDS at the end of 1998 ranged from 800,000 to 900,000. Among these persons, approximately one-third do not know they are infected with HIV. In addition, about four out of every 100 Americans engage in behaviors that put them at high risk for HIV infection.
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If you enjoyed the essays in the Pike by CDER alum and former Pike editorial board member G. Alexander "Zan" Fleming, M.D., you may be interested in reading his editorial in the Dec. 21 New England Journal of Medicine at http://www.nejm.org/content/2000/0343/0025/1886.asp.
The Pike is published electronically on the X:drive in Cdernews and on the World Wide Web at: http://www.fda.gov/cder/pike.htm. Photocopies are available in the Medical Library (Parklawn Room 11B-40) and its branches (Corporate Boulevard Room S-121 and Woodmont II Room 3001).
Views and opinions expressed are those of the authors and do not necessarily reflect official FDA or CDER policies. All material in the Pike is in the public domain and may be freely copied or printed.
Editorial Board
Celeste Bové
Charlene Cherry
Rose Cunningham
Bonnie Dunn
Pam Fagelson
Elaine Frost
Timothy Mahoney
Edward Miracco
Melissa Moncavage
Jim Morrison
Ellen Shapiro
Ted Sherwood
Tony Sims
Nancy Smith
Wendy Stanfield
Gloria Sundaresan
Marcia Trenter
Diane Walker
Grant Williams
Pamela Winbourne
Have ideas, news or comments to contribute?
Please contact a member
of the Editorial Board or:
News Along the Pike
CDER Office of Training
and Communications (HFD-200)
Parklawn Building, Room 12B-45
Editor: Norman "Joe" Oliver (OLIVERN)
Associate Editor: Patrick Clarke
Phone: (301) 827-1670
Fax: (301) 827-3055
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Last Updated: March 08, 2001
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