The Food & Drug Administration’s Center for Devices and Radiological Health saw 29 percent increase in complaints last year, logging a record high of 171 in 2010.
The surge in complaints is less dramatic than the 45 percent increase the agency saw from 2009 to 2010, but the number of contacts, comprised of complaints, disputes and inquiries the agency fielded rose from 250 to 414, up 66 percent.
The rise outstrips the 47 percent jump from 170 in 2008 to 2009. The ombudsman’s office, created in 2000, began keeping stats on complaints and disputes that year.
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MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
Nearly 270, or 65 percent, of the the contacts last year came from the medical device industry, trumping the number of calls last year from med-tech, consumers, healthcare providers and others combined, the FDA reported.
The FDA defines a complaint as “an expression of dissatisfaction, perhaps about timeliness, lack of communication, or an unhelpful employee,” whereas “a dispute usually involves a disagreement with, a challenge to, or an appeal of a decision or action the center has taken or is about to take.”
“An inquiry may be a question, a request for clarification, or an issue that does not rise to the level of a complaint or a dispute,” according to the agency.
On a more positive note, the agency reported 26 disputes, slightly less than half of the 53 rows reported last year.
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The CDRH also reported that the number of complaints, disputes and inquires involving the 510(k) process were down to 29, or 24 percent, from 38 in 2009. In all, 510(k)-related issues comprised 7 percent of all contacts, versus 17 percent in 2009.
The complaints, made primarily by industry, seemed to center on the agency’s Office of Device Evaluation, which accounted for about 40 percent of the contacts. The 164 contacts that office received was up 21.5 percent from last year’s 135. The FDA’s compliance office came in a distant second, logging about 21 percent of total complaints.
The most common reason for filling a complaint, dispute or inquiry was mis-communication or lack of communication — 88 of the contacts, or 21 percent of all calls. The most common topic was policy and procedure, with 193, or or 47 percent of all contacts.
Here’s the FDA data on contacts for 2001-2010:
| 2010 | 2009 | 2008 | 2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | |
| Calls | 414 | 250 | 170 | 177 | 120 | 114 | 125 | 120 | 53 | 72 |
| Complaints | 171 | 133 | 92 | 85 | 56 | 72 | 77 | 82 | 27 | 51 |
| Disputes | 26 | 53 | 31 | 55 | 40 | 25 | 39 | 38 | 26 | 21 |
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
