Nine To Noon for Tuesday 10 June 2008
Nine to Noon for 10 June 2008
9:05 US FDA changes stance on mercury fillings
Charlie Brown, lawyer for the group Consumers for Dental Choice; Michael Bender, plaintiff in legal action against FDA over classification of amalgam fillings; and Robin Whyman, Chief Dental Officer, Ministry of Health.
See Statement from the FDA at the bottom of this page.
9:20 Warning about 'greenwash' amongst NZ companies
Interview with Adrian Sparrow, Director of Fair Trading, from The Commerce Commission
9:45 US correspondent Jack Hitt
10:05 Isle of Eigg
Maggie Fyffe, Secretary of the Isle of Eigg Heritage Trust, who spearheaded the buyback of their island some 11 years ago this month.
10:30 Book Review: Trauma by Patrick McGrath
Reviewed by Quentin Johnson
Published by Bloomsbury, ISBN 978 074 759 6820
10:45 Book Reading: Edwin & Matilda by Laurence Fearnley
11:05 Business commentator Rod Oram
11:30 Consumer Rights with Denise Brailey
11:45 Media commentator Denis Welch
Statement from the FDA on Mercury Fillings
* As part of a mediated settlement with NAME, the FDA has updated
information on dental amalgam contained in the "Question and Answer"
segment on the agency's Web site.
* Link to the revised information
* Also as part of the settlement, the FDA agreed that the proposed
rule to classify dental amalgam will be finalized one year after the
current comment period ends.
* Of concern is the toxicity of dental amalgam. Dental amalgam
consists of 50 percent metal powder and 50 percent liquid mercury.
* In some cases, mercury may have neurotoxic effects on the
nervous systems of developing children and fetuses. FDA's classification
rulemaking will examine evidence concerning whether the presence of
mercury in dental amalgam can cause health problems.
* Dental amalgam is a "pre-amendment device," which means that it
was in use prior to 1976 amendments to medical devices law. That law
required FDA to classify pre-amendment devices into class 1, 2, or 3.
FDA classified the two separate parts of amalgam - dental mercury and
the metal powder - but did not separately classify the combination of
the two, dental amalgam. FDA is now in the process of completing that
classification for the combined product, dental amalgam.
* FDA has proposed to classify dental amalgam as a class 2 device,
which will enable FDA to impose special controls that provide reasonable
assurance of the safety and effectiveness of dental amalgam. FDA
recently reopened the comment period on that proposed classification,
specifically requesting information on appropriate labeling statements.
* For example, FDA asked how labeling controls should address the
disclosure of composition, including mercury content, and how labeling
should address precautions regarding use of the device in sensitive
subpopulations composed of individuals who respond biologically at lower
levels of exposure to mercury than the general population. Should the
labeling controls require more specific patient labeling (e.g.,
informing patients of identified sensitive subpopulations of the mercury
content, the alternatives to the device and their relative costs, and
health risks associated with the failure to obtain dental care)?
* As FDA develops the final classification, the agency will
examine evidence submitted to the docket concerning the safety of dental
amalgam.
* Over the past six years, the FDA has taken several steps to
assure that the classification of dental amalgam is supported by strong
science. In 2002, the agency issued a proposed rule to classify dental
amalgam and identify any "special controls" necessary for its safe
marketing to the American public.
* Due to a high number of comments on that rule, the agency held
an Advisory Committee meeting in 2006, inviting dental and neurology
experts to review existing scientific data on dental amalgam, especially
with regard to its toxicity in pregnant women and children.
* Link to the Advisory Committee meeting summary and transcript
* Then, on April 28, 2008, FDA reopened the comment period on the
2002 proposed classification in order to elicit the most up to date
comments and information related to the classification decision.