A recent national survey of orthopedic surgeons found that respondents generally view FDA as being too slow in its review and approval of new drugs and devices. A majority of the respondents indicated that they feel delays in FDA approval harm patients and hinder their practice of medicine.
The survey was developed by the Competitive Enterprise Institute (CEI; Washington, DC), a nonprofit, public-policy organization. Since 1995, CEI has conducted six physician specialty surveys, all of which have uncovered strong anti-FDA sentiments. However, CEI reports that responses to the orthopedic survey were the most pronounced in their condemnation of the agency.
"In recent years, FDA has been repeatedly attacked for approving allegedly defective therapies," said Sam Kazman, CEI's general counsel. "But as this physician survey shows, the real threat to public health is that FDA's approval process is already too long. Any attempt to make it more stringent will only worsen this problem."
The CEI report includes the following findings.
- 76% of surveyed orthopedic surgeons say FDA's approval process is too slow.
- 60% say FDA hinders their use of new therapies.
- 73% say FDA approval delays hurt patients.
- 70% favor changing laws to give physicians access to unapproved therapies if they carry a warning about their unapproved status.
"All new therapies carry risks, and sometimes those risks cannot be discovered until after clinical testing," Kazman says. "If we set a goal of zero unexpected risks, then the only way to meet that goal is through zero new therapies. As the results of this latest survey indicate, from a public health standpoint, that could well be the riskiest approach of all."
The CEI survey polled 175 orthopedic surgeons across the country. The survey included 13 questions that measured most opinions on a positive-negative response continuum. It was conducted by the Polling Company Inc. (Washington, DC), which reported the survey findings are subject to a 7.4% margin of error.
According to the report, younger orthopedic surgeons expressed a greater degree of dissatisfaction with FDA than their older colleagues. CEI cites this as a significant finding, as the demand for orthopedic surgeons is expected to grow in order to keep pace with the aging of 77 million baby boomers.
So far, no orthopedic society, professional journal, or trade organization has publicly responded to the survey, although it was cited in a positive light by a Wall Street Journal editorial.
CEI is generally recognized as a conservative, probusiness organization. Its "Death By Regulation" project focuses on raising public awareness of what the organization refers to as the often-hidden costs of government overregulation.A summary report and the complete survey are available at www.cei.org.
© 2007 Canon Communications LLCReturn to MX: Issues Update.