I am posting the following “members only” material from the Indoor Tanning Association (ITA) to help maintain awareness that the organization is committed to the task ahead – and that we need to work in unison and properly support their efforts. The ITA has engaged a top law-firm which specializes in FDA matters in order to best prepare and reach an accord with the FDA for, during and after the March 25 meeting. Here’s the scenario:
Food and Drug Administration Advisory Committee Meeting – March 25, 2010
The Food and Drug Administration announced that it will hold a public Advisory Committee meeting on March 25. According to the FDA’s announcement, the purpose of the meeting is to obtain information from industry and the public on a number of specific questions regarding how CDRH should anticipate and respond to new or evolving scientific knowledge regarding sunlamp products in a manner that is consistent with the FDA's mission to protect and promote the public health.
This meeting comes in response to pressure from Congresswoman Rosa DeLauro (D-CT), chairwoman of the House committee that appropriates funds for the FDA. Congresswoman DeLauro has urged the FDA to consider reclassifying sun beds to a stricter medical device classification.
Because this meeting and process the FDA has embarked upon is so important, the ITA has hired one of the top “FDA” law firms in Washington to help us develop a strategy and respond to the challenge.
The following are the immediate actions items in advance of the March 25 meeting:
•Contact senior personnel within the FDA's Commissioner's Office and the Device Center (CDRH) to obtain a better understanding of the internal Agency dynamic and what the FDA may ask the Advisory Committee to address specifically during the meeting (e.g. performance standards, more restrictive labeling, etc.). The goal of these meetings is to obtain candid feedback on the FDA's current position regarding tanning lamps, its plan for the Advisory Committee meeting, and its long-term regulatory strategy for these devices.
•Review and synthesize the scientific literature on the health impacts of tanning devices, as well as the critiques and related materials in order to have a full field-view on the underlying science to best position the ITA at the Advisory Committee meeting.
•Prepare written comments (e.g. a White Paper) in advance of the Advisory Committee. This will include a comprehensive assessment and critique of the various scientific reports referenced by Rep. DeLauro (IARC/WHO). The White Paper will be positioned as a neutral and un-biased analysis of the literature and will ensure that the Advisory Committee is aware of the flaws of the cited reports. This will be a critical step in establishing the Administrative Record at the FDA and ensuring that any discussion regarding additional labeling or other regulatory controls (e.g. performance standards) be based on a scientific record. This piece will also be used in other forums, including conversations with CDRH personnel, the Hill, and OMB in the event the agency proceeds with a rulemaking.
•Assist the ITA in its preparations for the Advisory Committee meeting, such as identifying potential speakers, attendees, etc. This will also include preparing both written and oral statements for the hearing.
•Engage in follow-up to the Advisory Committee meeting with the FDA to assess appropriate next steps.
Although this process is very serious, we remain confident that the data and science will position us to achieve our goals.
Leif Vasström is one of the industry’s most accomplished veterans and the mastermind behind SUPRA Brands Group, which offers the Supra Guarantee: better performance & longer life than any other lamp. If you have questions about the ITA or its merits, please contact him at 415.725.6666. For information regarding Supra, visit www.supratechnologies.com.
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