SEQUESTRATION AND DEVICE APPROVALS (Orthopedics This Week)
Avoiding “The Sequester” is Washington’s new pork.
Medical device companies are going to pay about $100 million in Food and Drug Administration (FDA) user fees in 2013 to help cover the costs of being regulated. However, due to sequestration, the FDA can’t touch $85 million of that. That means a slowdown in device reviews, clearances and approvals.
Legislation was introduced in both the House and the Senate recently to shield what the FDA gathers directly from industry. The bill was assigned to a congressional committee on July 31, 2013, which will consider it before possibly sending it on to the House or Senate as a whole. Unfortunately, Congress just went on a one-month vacation.
Steve Ubl, president and CEO of AdvaMed, issued a prepared statement which pointed out that since the sequester took effect earlier this year, medical device and diagnostics companies have been paying the full amount of user fees to FDA as negotiated under last year’s new Medical Device User Fee Agreement, as enacted in the FDA Safety and Innovation Act (FDASIA).”
In FY 2013, according to AdvaMed, $2.9 million in medical device user fees will not...
