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Lifelines
of the NATIONAL ASSOCIATION OF CANCER PATIENTS
Vol. II, No. 1 û August 1997
Collaborative rather than adversarial relationship desired
A change of culture at FDA:
Will it translate into faster approvals?
 Founding director William Otterson met with interim FDA director Dr. Michael A.
Friedman during a recent visit to Washington, D.C.
by William Otterson
A recent trip to Washington, D.C. to attend meetings of the National Cancer Policy Board, a group set up by the
National Academy of Sciences to advise the President and the Congress on issues affecting cancer research, also
gave me an opportunity to meet with Dr. Michael A. Friedman, interim director of the FDA, and senior members of
his staff. Dr. Friedman suggested that he is open to ideas as to what industry and the FDA can do in concert to
get efficacious products to the consumer more quickly. In my view, just posing the question indicates that a change
of culture has occurred at FDA, or perhaps is still occurring. If so, it may present some opportunities for more
collaborative interactions between industry and the FDA in the future, which would be a significant improvement
over the adversarial relationships frequently in evidence.
Dr. FriedmanÆs remark came as the result of his review of a 1995 industry report (UCSD
CONNECT/ Price Waterhouse) which evaluates the performance of FDA and suggests areas where improvements are
needed. The report is currently being updated for publication later this Fall.
Grateful Patients Award
My visit with Kathryn C. Zoon, Ph.D., head of the Center for Biologics Evaluation and Research (CBER) was even
more exciting. Not only does Dr. Zoon keep her National Association of Cancer Patients ôGrateful Patients Awardö
in her bookcase, but she is also thoroughly familiar with the 1995 industry report.
ôThe report is extraordinarly helpful in giving us the pulse of the industryÆs perception of the FDA,ö she said.
Dr. Zoon is the second honoree selected for NACPÆs Grateful Patients Award. The first recipient was D. Bruce Burlington,
M.D., director of the Center For Devices and Radiological Health (CDRH). His award was presented last year, and
is still prominently displayed in his bookcase. During our recent visit, he told me he is particularly interested
in the 1997 update of the FDA report. ôWe hope it shows that our hard work is making a difference. We need to know
how our actions are being perceived by industry,ö he said. ôWe believe that [effective] new drugs and devices are
important to the American people and understand how critical timeliness is [in getting devices to market].ö
Dr. Burlington has been active with the Grassroots, FDA/Medical Device Industry Initiative. This group is working
out the details of pre-announced GMP inspections for companies who have demonstrated a favorable compliance track
record. Results of the pilot program showed a reduction in time spent by FDA auditors and industry officers, because
required data was made available ahead of time. Most importantly, the program tended to facilitate a better working
relationship between the companies and the FDA.
Reinventing the FDA
I also met with Bob Stone, chief energizer for the National Performance Review, and Jean Logan, his deputy on
FDA streamlining. They are excited about the progress being made in reinventing FDA. Stone, in particular, is looking
for ways industry can praise the FDA for results achieved, as he feels that a few ôatta boysö would go a long way
to speed up the reform process.
In the California Legislature
NACP has been active in supporting several cancer-related bills in the California Legislature this year. We won
a few, lost a few, but at least they heard our views. Credit should to our Legislative Chair, Dr. James Berkovec,
who follows events in Sacramento and issues alerts when we need to take action. Here are some of the California
bills we have followed:
SB 77 - To provide $18 million for prostate cancer research. (Status: Bottled up in committee.)
AB 833 - To establish the Ovarian Cancer Information Program within the Department of Health Services. (Status:
Held in committee, could become a 2-year bill.)
AB 1554 - To provide $27 million for prostate and ovarian cancer research. (Status: Amended to provide $3 million,
included in budget now on GovernorÆs desk.)
WeÆre interested in other states, too, so let Jim know whatÆs going on where you live and how we can help. He prefers
to be contacted via e-mail: jberkove@cyber8t.com.
Join NACP, get involved
The membership of NACP is made up primarily of cancer patients, the families and friends of cancer patients, and
physicians involved in the daily care of cancer patients or in cancer research. It is open to anyone sharing the
goals of NACP. You are cordially invited to become a member. Call (760) 598-8289 for information and a membership
application.
Federal agencies bolster Ward Valley project,
NACP activities aimed at ending delay
Two federal agencies have raised serious questions about the Department of the InteriorÆs handling of CaliforniaÆs
request for land in Ward Valley which the state has licensed for use as a low-level radioactive waste disposal
facility, and a third agency has concluded that far less waste will actually go into the facility than had originally
been anticipated.
The General Accounting Office (GAO) issued a report that is highly critical of InteriorÆs actions, stopping
just short of saying those actions are politically motivated. The report concludes that preparation of a second
Supplemental Environmental Impact Statement (SEIS) as proposed by Interior is not warranted by the facts, and that
Interior has neither the authority nor the expertise to make judgments about radiological safety.
Interior Deputy Secretary John Garamendi was grilled by members of the Senate Energy & Natural Resources
Committee at a hearing on July 22.
The Congressional Research Service also issued a report which concludes that only about 1.4 million curies of radioactivity
will actually be disposed of at Ward Valley, instead of 5.3 million curies of radioactivity originally predicted.
Although Senator Barbara Boxer seized on the report as an indicator that most of the waste will come from nuclear
utilities. State of California officials viewed it as an indicator that the siteÆs conservative safety margin is
even wider because of the change in anticipated disposal amounts.
And the Chairman of the Nuclear Regulatory Commission jumped into the fray, taking the Interior Department to task
over a number of Ward Valley issues. In particular, Chairman Shirley Jackson chastised Secretary Bruce Babbitt
for not consulting with the NRC on technical issues. She also criticized Deputy Secretary John Garamendi for issuing
a ôFact Sheetö at a February 1996 news conference which contained factual errors and misleading statements. She
expressed concern that the waste stream projections used in the ôFact Sheetö are identical to those published by
Committee to Bridge the Gap, a leading project opponent, but were erroneously attributed to the NRC. The document
is misleading by implying that medical wastes are safer than nuclear power plant wastes, she said.
Members of NACP participated in a related news conference held by California Governor Pete Wilson in Sacramento,
gave several media interviews during the Senate hearing on July 22, and published pro-Ward Valley ads in Roll Call,
a Washington, DC publication, and The Washington Edition of the Los Angeles Times. [The ad is reproduced on this
page; contact the editor if youÆd like a full-sized copy.]
Negroni, Rabe elected
Daniel Negroni has been elected as President of NACP, succeeding founding President Keith Boesky. And Mary
Rabe has been elected to fill an existing vacancy on the Board of Directors. Negroni and Rabe are both cancer survivors.
Lifelines is published by the NATIONAL ASSOCIATION OF CANCER PATIENTS. Comments on its content and
suggestions for articles are welcome.
Nicki Hobson, Editor,
2070 Ridgeline Avenue
Vista, CA 92083
Phone: (760) 598-8289
Fax: (760) 598-7304.
Check out our web page! NACP now has a web page with news about our activities and links with many other sources
of information about cancer, cancer research, clinical trials, and much, much more. You can find it at: www.cancerpatients.org.
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