The July 15 meeting minutes between the FDA and industry indicate that discussions continue to focus on “mitigating uncertainties” that exist in the medical device authorization process. From the FDA’s perspective, many of these uncertainties are due to “budget appropriations and legislative uncertainties.”
At the July 15 meeting, the FDA asked industry to present a detailed set of proposals at the next meeting on July 26, stating that “the best way for all parties to manage uncertainty is to accelerate progress on substantive issues in these negotiations.” The FDA may have been right on the mark in characterizing legislative uncertainties as a primary concern. In the past few weeks, the U.S. Senate health committee has evidenced internal dissention, with Sen. Richard Burr indicating that he would create “a slow and laborious process” for reauthorizing the user fee program if he was dissatisfied with changes to the drug and medical device approval process. Committee chair Sen. Tom Harkin disagrees with Sen. Burr’s assertion that “time to market” is the most important factor in the device approval process, believing instead that safety and effectiveness are paramount.
Despite continued negotiations, on August 1 the FDA announced that annual fees for medical devices will be reduced by approximately seven percent in 2012.
The contents of the July 26 meeting minutes, not yet posted by the FDA, should reveal where negotiations stand. The FDA hoped to have industry’s complete set of detailed proposals so the parties could reach an agreement by the end of this month, allowing the FDA time to prepare draft recommendations for publication in the October Federal Register. Final recommendations are statutorily due to Congress by January 15, 2012.