The Health Care Policy Blog is a forum for health care policy professionals and Bloomberg BNA editors to share ideas, raise issues, and network with colleagues.
Thursday, May 2, 2013
by John T. Aquino
The effects of sequestration on the Food and Drug Administration were apparent in a particular way at the BIO 2013 International Convention in Chicago that I covered—FDA officials didn’t have the budget to fly there.
.The BIO convention is one of the best attended in the life sciences industry with over 13,000 participants. The FDA Roundtable always has drawn well, and FDA staff often have participated on other panels. Attendees who work for biopharmas look forward to the opportunity not only to hear FDA personnel provide updates on what their particular center at the agency is doing but also to ask them questions during and after presentations and at the many networking sessions the convention offers.
But at the FDA Roundtable in Chicago, Dr. Douglas C. Throckmorton, deputy director for regulatory programs for FDA’s Center for Drug Evaluation and Research, and Dr. Karen Midthun, director of FDA’s Center for Biologics Evaluation and Research, gave their presentations by SKYPE while at FDA’s White Oak campus in Silver Spring, Md. The moderator attributed their absence from the convention to the sequestration budget cuts—automatic, across-the-board cuts to federal agency spending mandated by the Budget Control Act of 2011 (Pub. L. No. 112-25) that took effect March 1.
At a session on how to avoid having a clinical hold put on your clinical trial, Stephanie Simek, deputy director of FDA's Office of Cellular, Tissue and Gene Therapies, also unable to travel to Chicago, spoke by means of an attendee’s cell phone that was connected to the speakers system. When someone asked a question, the attendee had to whisper it into the cell phone so that Simek could hear it and respond.
The inability of FDA staff to travel to conferences may seem like a trivial matter. But, ironically, the message of the clinical hold session was to take every opportunity to meet with FDA staff. The ability of agency personnel to participate in conferences like BIO 2013 provides an opportunity for thousands in the life sciences industry to meet with them in one location. FDA staff’s absence from meetings like this—which will surely continue in the near future--is a consequence of sequestration that might have a more negative effect than one might initially think.
.
You must Sign In or Register to post a comment.
Impact of Sequestration on Life Sciences--FDA Can't Travel(1)
Are Medicare Fraud Tipsters in Line for a Big Payday?
HHS Issues Streamline Applications For Health Coverage