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The catalog, training materials, schedule and on-line registration can be found at
http://oitweb/.By Arzu Selen, Ph.D. and Dale F. Wilcox
The new Academics to CDER Program uses the capacity and skills of local academic institutions to enhance and increase the opportunities for scientific education in the Center. The program's first activity, "Pharmacokinetics and Pharmacodynamics for CDER Reviewers," was developed jointly by the Center and Georgetown University's Center for Drug Development Science.
This course, held in six half-day sessions from Feb. 17 to March 23, was attended by 112 scientists and medical officers from CDER, CBER and CVM, as well as 17 Georgetown fellows.
The instruction consisted of lectures, breakout sessions to examine case studies and a panel discussion. The course focused on fundamental pharmacokinetic and pharmacodynamic concepts and illustrated how they applied to regulatory decision-making. Scientists from academia, industry, CDER's Office of Clinical Pharmacology and Biopharmaceutics and CBER developed the lectures. The examples for the breakout sessions were selected from reviews conducted in OCPB. These examples were prepared by the Office of Training and Communications, OCPB and the Quantitative Research Methods Staff from the Office of Biostatistics.
The diverse background of the lecturers and the faculty facilitated an in-depth overview of fundamental concepts, critical factors that influence study outcomes and decision-making during drug candidate selection, development and review.
The applications of the scientific principles in guidance documents was presented in the lectures, panel discussion and illustrated by examples in the breakout sessions. The examples demonstrated the impact of pharmacokinetic and pharmacodynamic studies on drug development and patient care as reflected in optimized dosing recommendations in drug labels. The occasional difficulties encountered in these studies were also recognized and presented. The course discussed how effective use of these tools will contribute to optimized drug development programs and individualized therapy.
The course curriculum was developed in response to an OTCOM core competencies assessment conducted last year that identified the knowledge and skills reviewers need.
OCPB Director Larry Lesko, Ph.D., and Georgetown's Carl Peck, M.D., led the planning committee that included Georgetown's Charles Grudzinskas, Ph.D., and, from CDER, John Senior, M.D., Shiew-Mei Huang, Ph.D., Stella Machado, Ph.D., and Daniel Shames, M.D., and the course coordinators, Peter Lee, Ph.D., and Arzu Selen, Ph.D., both from OCPB, and Dale Wilcox from the Division of Training and Development.
Future plans include identifying other opportunities for collaboration with academia. An additional component of the Academics to CDER Program will be a visiting professor lecture series scheduled to begin in September.
Arzu Selen is Deputy Director of DPE III in OCPB, and Dale Wilcox is Deputy Director of DTD in OTCOM.
By Karen Zawalick
CDER medical officers and invited speakers can now earn Category 1 continuing medical education credit for lecturing at an accredited CDER educational activity such as a training course, scientific rounds and scientific seminar.
As a result of a December decision by the American Medical Association, an approved provider of CME such as CDER may now award up to two Category 1 credits for every one hour of lecture up to a maximum of 10 hours per year. The learning activity must be designated for Category 1 CME. A copy of the course or seminar announcement will be accepted as proof of participation.
Please contact me (ZAWALICKK) for more information.
Karen Zawalick is an education specialist in the Division of Training and Development.
By Tony Chite
1. Congress passed the Prescription Drug User Fee Act, which authorized user fees from drug companies to hire more scientists to review new drugs in:
a. 1989 b. 1991 c. 1992 d. 1993
2. Congress reauthorized PDUFA and passed the Food and Drug Administration Modernization Act. FDAMA codified a number of practices that had become common in the Agency, such as, expanding the use of "accelerated approval" mechanisms for drugs for life-threatening conditions and using surrogate endpoints in clinical trials. It also included a number of mechanisms for speeding FDA review and changed the legal standard for new drug approval to a single clinical trial (instead of two). These actions took place in:
a. 1995 b. 1997 c. 1998 d. 1996
3. Who did not serve as a Commissioner of Food and Drugs:
a. C. Everett Koop, M.D. b. Harvey Wiley, M.D. c. Frank E. Young, M.D., Ph.D. d. Arthur Hull Hayes, M.D. e. Jane E. Henney, M.D.
4. In 1930, under an agricultural appropriations act, the name of the Food and Drug Administration was shortened from:
a. Food, Drug and Narcotic Administration b. Food, Drug and Cosmetic Administration c. Food, Drug and Device Administration d. Food, Drug and Insecticide Administration
5. In 1862, President Lincoln appointed Charles M. Wetherill to serve in the new Department of Agriculture. This was the beginning of the Bureau of Chemistry, which was the predecessor of the:
a. Food and Drug Administration; b. National Institutes of Health; c. Drug Enforcement Administration; d. Bureau of Alcohol, Tobacco and Firearms
Tony Chite is a CSO in CDER's Freedom of Information Division.
Answers: 1c; 2b; 3a; 4d; 5a.
FDA approved a new drug, gemtuzumab ozogomicin, on May 18, for the treatment of CD33 positive acute myeloid leukemia. The drug is approved for patients 60 years or older who have relapsed for the first time and are poor candidates for cytotoxic therapy. Mylotarg was approved as an orphan drug, a drug intended for the treatment of rare diseases or conditions.
This new treatment is given in IV form as a 2-hour infusion in two doses given 14 days apart. Standard chemotherapy is given in the hospital for seven days and requires patients to be hospitalized for an extended period of time.
Myeloid leukemia is characterized by a rapid accumulation of abnormal white blood cells in the blood and bone marrow, resulting in severe anemia, infection and hemorrhage during the course of the disease.
Three clinical studies with Mylotarg involved 142 patients with surrogate markers based on rates of complete remission. A total of 80 patients were age 60 or older. Side effects included liver toxicity. During the clinical trials 14 percent to 24 percent of patients showed elevations in liver enzymes leading to clinical liver disease and jaundice.
The drug is manufactured under the trade name Mylotarg by Wyeth Ayerst of Philadelphia.
FDA announced June 8 that it will extend until Dec. 31, 2002, implementation of a comprehensive final sunscreen monograph. This announcement reflects the Agency's Oct. 1 decision in a citizen's-petition response to allow additional time for the completion of a comprehensive sunscreen monograph that is expected to include standards for both ultraviolet A and ultraviolet B radiation.
To comply with the FDA Modernization Act of 1997, the Agency had published a final OTC monograph for sunscreen products in the Federal Register of May 21, 1999. The monograph did not, however, address certain issues involving active ingredients, labeling and test methods for products intended to provide UVA coverage.
FDA is amending the date the sunscreen monograph takes effect to accommodate the final completion of standards for UVA formulation ingredients, labeling and testing. The completed monograph may also address issues associated with the testing and labeling of sun protection factor values above SPF 30.
FDA will also consider ways to integrate UVA and UVB indications. As a result of the amendment to the effective date, sunscreen products are not required to comply with the general OTC labeling rule until Dec. 31, 2002.
HHS Secretary Donna E. Shalala announced on May 23 several new initiatives to further strengthen protections of human research subjects in clinical trials. The department's actions are designed to heighten government oversight of biomedical research and to reinforce to research institutions their responsibility to oversee their clinical researchers and institutional review boards.
"In the last few years, we've seen dramatic advances in the effort to find new therapies for cancer and other diseases, and we've taken new steps to protect the safety of patients in clinical trials," Shalala said. "But the explosion in biomedical research has also brought new challenges, as more researchers are becoming involved in commercial ventures that may create new ethical dilemmas."
The HHS actions focus on:
Shalala also stressed the responsibility of the leaders of universities and academic medical centers to oversee IRBs.
HHS will undertake an aggressive effort to improve the education and training of clinical investigators, IRB members and associated IRB and institutional staff.
NIH, FDA and the new HHS-level Office for Human Research Protections will work closely together to ensure that all clinical investigators, research administrators, IRB members and IRB staff receive appropriate research bioethics training and human subjects research training.
Such training will be a requirement of all clinical investigators receiving NIH funds and will be a condition of the NIH grant award process.
NIH and FDA will issue specific guidance on informed consent, clarifying that research institutions and sponsors are expected to audit records for evidence of compliance with informed consent requirements. For particularly risky or complex clinical trials, IRBs will be expected to take additional measures, which, for example, could include third-party observation of the informed consent process. The guidance will also reassert the obligation of investigators to reconfirm informed consent of participants upon the occurrence of any significant trial-related event that may affect a subject's willingness to participate in the trial.
NIH will now require investigators conducting smaller-scale early clinical trials (Phase I and Phase II) to submit clinical trial monitoring plans to the NIH at the time of grant application and will expect investigators to share these plans with IRBs. The NIH already requires investigators to have such plans and they also require large-scale (Phase III) trials to have Data and Safety Monitoring Boards. For research on medical products intended to be marketed, FDA will also issue guidance for DSMBs that will delineate the relationship between DSMBs and IRBs and define when DSMBs should be required, when they should be independent, their responsibilities, confidentiality issues, operational issues and qualified membership.
NIH will issue additional guidance to clarify its regulations regarding conflict of interest, which will apply to all NIH-funded research. HHS will also hold public discussions this summer to find new ways to manage conflicts of interest so that research subjects are appropriately informed and to further ensure that research results are analyzed and presented objectively.
In addition, these public discussions also will focus on clarifying and enhancing the informed consent process. Based on these public forums, NIH and FDA will work together to develop new policies for the broader biomedical research community, which will require, for example, that any researchers' financial interest in a clinical trial be disclosed to potential participants.
HHS will pursue legislation to enable FDA to levy civil monetary penalties for violations of informed consent and other important research practices-up to $250,000 per clinical investigator and up to $1 million per research institution. While FDA can currently issue warning letters or impose regulatory sanctions that halt research until problems are rectified, financial penalties will give the Agency additional tools to sanction research institutions, sponsors and researchers who do not follow federal guidelines.
A new HHS-level office will lead efforts for protecting human subjects in biomedical and behavioral research, the department announced on June 6.
The new office will be located in the office of the Assistant Secretary for Health. It replaces the Office for Protection from Research Risks, which was part of the NIH and had authority over NIH-funded research. The new office will also provide leadership for all 17 federal agencies which carry out research involving human subjects under a regulation known as the Common Rule.
HHS will also charter a new National Human Research Protections Advisory Committee, to provide broad-based counsel on patient protection and research needs.
By the RAC representatives
Dear Colleagues,
It is with great regret that we announce that, as of May 31, the Reviewer Affairs Committee has officially been disbanded.
The committee conducted a survey asking CDER reviewers their opinion on the utility of keeping the committee. We had an overwhelming response in favor of retaining the RAC and conducting business in the same democratic way we always have. Eighty-nine percent of responses were in favor of continuation, with a fair number of those stating that it was important for the RAC representatives to continue to be appointed by CDER's primary reviewers. The survey also revealed that reviewers desired that the RAC represent all primary reviewers, both bargaining unit members and non-bargaining unit members such as Commissioned Corps officers and visiting scientists.
The RAC presented the survey results to the Center's management. In return, they presented the NTEU with the data generated from the survey and expressed CDER's desire that the RAC continue in the way it had in the past. However, the NTEU feels very strongly that they should appoint all bargaining unit members to the RAC and decide which non-bargaining unit members can participate. Because this position is incompatible with the expressed desires of the reviewers and the RAC's current charter doesn't support continuing the committee in the manner in which the NTEU is proposing, Center Director Janet Woodcock, M.D., stated that the best alternative would be for the RAC not to be reconvened.
A final meeting between Dr. Woodcock and RAC representatives was held on May 31. RAC representatives asked Dr. Woodcock how the "unfinished business" such as the evaluation of the CDER Reviewer Career Path and comparable pay issues for review disciplines would be competed.
Dr. Woodcock said the Center would evaluate the career path program and publish the results. She will discuss with OTCOM and OM to determine the most appropriate organizational location for the program. She said the Center had proposed a pay comparability plan for pharmacokineticists and biostatisticians. Other centers have concerns about the impact of the proposal on their organizations, which will have to be addressed
A business case was made that included compelling data on drastic attrition rates directly related to the disparity between current federal salaries with those in the private sector for clinical pharmacologists. If CDER is successful in obtaining approval of this plan, it will look at other review disciplines to see if a business case can be made for additional requests.
The RAC was established to provide a forum for all CDER primary reviewers to improve communication among reviewers and to represent the needs and concerns of primary reviewers directly to Center management. The RAC carried out its mission with distinction over the past six years, and those who have served on the committee should be very proud of their many accomplishments. We hope the union will pick up where the RAC left off and continue with many of the efforts for which the RAC has laid the groundwork because these projects were the desires and concerns of CDER reviewers.
All the RAC representatives joined collectively to write this farewell article to CDER reviewers.
There's been many a time when riding the Parklawn elevator that I've stepped off on the wrong floor because I wasn't watching where I was going. There are other times, when crossing the street, that I failed to notice that the walk sign has given me permission to cross. I've then had to hurry across with "don't walk" flashing furiously.
The obvious answer is for me to get my head out of the clouds and pay attention. The not-so-obvious answer is that accommodations for people with real disabilities can also help normal folks, including those of us who are chronically inattentive.
Elevator and walk signs provide good examples. Some elevators now use a recorded voice to announce the number of the floor at which they are stopping. I was in San Diego earlier this month, and some of their walk signs make a chirping sound when the signal to walk first illuminates. That gave me plenty of time to stop sightseeing and get safely across the street.
All of this brings us to a recent e-mail from Vincent Andolina, a Pike reader in AOL Land. He writes: "Thanks for posting News Along the Pike in HTML format as well as in Acrobat format. The HTML format is easier to read on screen."
You're welcome, of course, Vincent; but it wasn't exactly generosity of heart that led me to create an HTML version in addition to the PDF one. You may have also noticed the CDER 1999 Report to the Nation was published in both Adobe
PDF versions and HTML versions.When challenged on this issue in the past, I've acknowledged that the PDF versions of the report and the Pike might be less than optimum for people with visual impairment. I thought, however, that it was a pretty good compromise.
It turns out-correctly-that others, including the Congress, disagreed. In 1998, they amended the Rehabilitation Act and strengthened its provisions covering access to information in the Federal sector for people with disabilities. As amended, Section 508 of the Rehabilitation Act requires access to the Federal government's electronic and information technology. The law applies to all Federal agencies when they develop, procure, maintain or use electronic and information technology. Federal agencies must ensure that this technology is accessible to employees and the public. There's a Website about this issue at
http://www.section508.gov.Access for publications like the Pike and the Report means making sure they are available in HTML format. The deadline for accessibility is Aug. 7, so I'm getting a head start. If you need to read the Pike on line, have poor eyesight, are using a small monitor or need to use a text-to-voice converter, by all means use the HTML version. If you want to send it to one of those fancy wireless phones, use the HTML version. If you're going to be making a printout and you have normal eyesight, use the PDF. You'll save lots of trees!
CDER's Spring Honor Awards Ceremony: Normally, we would have had a story about the June 16 event in this issue. Unfortunately, a bad combination of out-of-town meetings and vacations is going to delay the story until the next issue.
Corrections: Credit for authoring last month's Page 1 story on how CDER's laboratories earned accreditation from the Association for Assessment and Accretion of Laboratory Animals International should have gone to Patricia E. Long-Bradley. In the same story, Joseph Hanig, Ph.D., should have been included in the list of members of the Institutional Animal Care and Use Committee who lent their support and expertise to the effort to gain accreditation.
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
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Editor: Norman "Joe" Oliver
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Last Updated: March 08, 2001
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