[gap height=”20″]With the Obama Administration entering its final six months, it has been widely reported in Washington that regulators throughout the Federal Government are racing to finalize as many pending regulations as possible before the clock runs out in December.
[gap height=”20″]Pressed by the uncertainty of who will control the Executive Branch and Congress after the November 2016 elections, all agencies including the FDA have been told to prioritize workload and move quickly to issue final rules. Because officials at the FDA have said, unofficially, that the Agency plans to finalize amendments to the performance standard and restricted device proposal before the end of the year, we must assume we are on the FDA’s “priority” list. The FDA may be able to meet this schedule; but, with summer vacations and senior political appointments rapidly moving out of government, this may be a stretch for the Agency.
[gap height=”20″]However, with this timeline in mind and in an effort to ensure the FDA fully understands the industry they so closely regulate, the ITA and ASA have requested a face-to-face meeting with the officials responsible for the two proposed rules.
[gap height=”20″]As I’ve reported in previous Updates, the FDA doesn’t really understand how much smaller the industry is, compared to six years ago when this process started – probably 50% smaller by most accounts. This is important, because one of the FDA’s expressed goals is to reduce UV exposure which, because of the Tan Tax, state and federal regulations, and misinformation from the media, has already been accomplished.
[gap height=”20″]We also want to make sure the FDA understands the implications of the other key issues in the two proposals: the flaws in harmonizing with many IEC requirements, especially the recommended exposure schedule; the Agency’s apparent lack of understanding of the totality of the science regarding UV exposure and melanoma skin cancer; how the economic analysis fails to adequately measure the proposed rule’s significant impact on small businesses; and the need for clarification on the status of existing equipment when the new regulations go into effect.
[gap height=”20″]We feel our interactions with the FDA over the years have demonstrated we are not unreasonable people. We look forward to this meeting as another opportunity for ITA to demonstrate our willingness to work cooperatively to protect your interests. Join us, won’t you?
