Hi All,
I have been doing a little internet research on the flu vaccine crisis. Here are some of the things I found so far on the FDA in general:
The following link uses the words modernizing - which is Republicanspeak for relaxing standards.
It also uses the term risk assessment which I personally find alarming when used in context with human health.To me, that sounds like risk/cost benefit analysis and I don't want my government to put a dollar figure on my health.
In addition, it discusses the FDA's increased emphasis on fast-tracking new drug applications which I think is very dangerous
http://www.pti-international.com/index.cfm/Link=138 Deputy FDA Commissioner, Dr. Lester Crawford, Discusses FDA
Initiatives
By Katy Kuipers, PTi international Program Developer
As pharmaceutical therapies grow increasingly complex, the FDA
is focused on modernizing and improving its drug approval
process.
Dr. Lester Crawford, Deputy Commissioner of the
FDA, recently outlined the agency’s most important present and
future initiatives, including:
designing and managing all of FDA’s regulatory
activities based on scientific risk assessment
providing consumers with sufficient information to
weigh the benefits and risks of FDA-regulated products
reducing medical errors and other adverse events
protecting the public against potential terrorist
attacks
strengthening scientific potential
Crawford spoke May 15 at The Wall Street Transcript’s 3rd Annual Biotechnology Industry Conference in New York. He explained that in response to the recent decrease in new drug applications, one of the FDA’s most important initiatives is to reduce median time to approval of presented products. The FDA is taking a proactive approach to the shortfall of applications and is trying to be especially sensitive to critical drugs which need to reach market as soon as possible. Its May 2001 accelerated approval of Novartis’s Gleevac demonstrates this aim.
In order to strengthen scientific potential and speed product development, the FDA will run 2 pilot programs in the next 3 years to test the concept of a continuous marketing application for fast-track drugs and biologics. Briefly, the first pilot program will involve FDA review of portions of an application prior to the submission of the complete application.
The second pilot program will institute frequent scientific exchanges between reviewers and manufacturers while a product is being investigated. Rewards may be given to manufacturers who have more
frequent FDA contact.
The FDA has been applying its new concepts of risk management and quality assurance to overhaul the GMPs or "good manufacturing practices." An FDA task force has been given 2 years to mold the GMPs to modern quality assurance practices.
Overall, Dr. Crawford was optimistic that the FDA would reach its goals of faster approvals and smarter, modernized guidelines.
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This link discusses the appointment of Lester Crawford to FDA top position:
http://www.hivandhepatitis.com/hiv_and_aids/public/100501d.html Lester Crawford May Be Choice as FDA Chief
HHS Secretary Tommy Thompson is seeking support on Capitol Hill for food safety expert Dr. Lester Crawford to become FDA commissioner, though he has not publicly announced Crawford as his choice, the New York Times reports.
<snip>
The Times reports that while Crawford, whose Center for Food and
Nutrition Policy is independently financed, "appears to escape that criticism," though some consumer advocates say the center "receives too much support from industry," the Times
reports (New York Times, 10/3/01).
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A note from the FDA on 2002 about vaccine shortages:
Important points include:
Deficiencies in manufactoring might be allowed by the FDA
The FDA does not have the authority to make companies produce needed vaccines (Why not?)
The FDA provides the flu vaccine to the vaccine companies to manufacture in bulk, so the companies do NOT ear the cost of research and development for the flu vaccine - they just need to make it in bulk.
The number of government agencies that contribute to vaccine availability in the US is complex and convoluted and it is my opinion that US health agencies need their own 9/11 commission to figure out how to streamline and organize their processes.
http://www.fda.gov/ola/2002/childhoodvaccines0612.htmlJune 12, 2002
When FDA inspects a vaccine manufacturer and finds deficiencies, the
Agency carefully considers the impact on product availability before taking action.
<snip>
In some situations, the Agency may determine, after
balancing all factors, that a decrease in the availability of a "medically necessary product" could pose a substantial risk to patients.
In such
cases, FDA regulatory action may allow manufacturing of the critical product to continue, provided that certain conditions are established to
ensure product safety.
The Agency evaluates each circumstance on its own facts, balancing the medical need for the product against the
safety assurances in place before product is released for use.
While FDA works proactively and interactively with manufacturers to address shortage issues, it is important to note that FDA does not have
the authority to require manufacturers to stay in the market and produce a given vaccine, nor does FDA have the authority to direct
manufacturers to increase production when a shortage occurs.
<snip>
Every year FDA scientists help to provide to manufacturers new strains for the yearly influenza vaccine as well as biological
standards for assessing the vaccine's potency. Ongoing FDA research on influenza is also designed to prepare for the possibility of
another global influenza pandemic. These efforts by FDA reduce the need for duplicative efforts by manufacturers and shorten the time
frames required for vaccine production every year.
FDA works proactively in collaboration with established interagency working groups and vaccine committees. Vaccine issues are a
priority for the Agency and the Department of Health and Human Services (HHS or the Department). The Department has shown its
commitment to vaccine issues through coordinating interagency groups to focus on vaccine safety and supply, among other issues. FDA
participates as an ex officio member of the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization
Practices (ACIP), the National Vaccine Program Office's (NVPO) National Vaccine Advisory Committee, and the Health Resources and
Services Administration's (HRSA) Advisory Commission on Childhood Vaccines (ACCV). In turn, the CDC, NVPO, and NIH participate in
FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). These advisory committees have specific and unique
responsibilities, and provide important opportunities for input from the public, including consumers, industry, and academia. FDA also
participates in the Interagency Vaccine Group (IAVG) and its executive committee. The IAVG includes various HHS agencies and
representatives from the U.S. Agency for International Development and the Department of Defense. FDA is also a member of an IAVG
Working Group that is developing options to present to the Department to address the vaccine supply issues, and participated in a
recently held vaccines shortage workshop held in February 2002.
http://epw.senate.gov/108th/Crawford_071703.htm*****************************************************************
Some links to testimony to the Congress:
http://www.cdc.gov/nip/news/testimonies/vac-shortages-FDA-6-12-2002.htmhttp://www.pharma-rd.net/2003/wvc_CA/confprog.asp?&T1=16/10/104&T1=16/10/104