In January, two senior legislators who are longtime industry supporters met with FDA officials to discuss the pending administrative order to reclassify sunlamp products to Class II medical devices. It is my belief that the FDA realizes it made mistakes when it issued the proposed order. The ITA highlighted these mistakes in our comments, which are linked on the ITA’s website, theita.com. The meeting with the FDA was another opportunity for FDA officials to hear that Members of Congress also think mistakes were made in the process and that Congress is watching developments closely.
So as we move into the second quarter of 2014, no news is good news, and for now, all is quiet at the FDA. As everyone is well aware, this year we could possibly see two actions by the FDA that could have a major impact on our industry – the proposed order to reclassify sunlamp products, and a rulemaking to amend the performance standard for sunbeds.
On Capitol Hill, the recent budget agreement for 2014 will restore what legislators call “regular order” to the process for funding the government in 2015. This process began in March. For us, this means our adversaries again have legislative vehicles moving through the authorizing and funding committees that could provide opportunities for mischief.
Remember in 2012, Rep. Rosa DeLauro offered an amendment to the FDA appropriations bill that would have required the FDA to reclassify sunlamp products to either Class II or Class III medical devices. Our challenge will be to continue to remind our supporters that a similar effort is always possible and make sure we are prepared should anyone try a similar move.
At the ITA’s budget meeting in December, the Board passed a budget that sets aside a “war chest” to deal with anything that might come out of the FDA this year. We hope we don’t have to use it but, as the old saying goes, “plan for the worst and hope for the best.”
Thanks,
John Overstreet
