In recent years there has been mounting criticism of the U.S. Food and Drug Administration’s approval process for new medical drugs and devices. Critics have claimed that newly-discovered risks for several therapies demonstrate that FDA’s current process is inadequate.
But there is another side to this story. Any attempt to make FDA’s approval process more stringent will add to its length and expense, making the development of new therapies even more difficult. In the view of many analysts, impeding the availability of new therapies creates a far greater risk to public health than that posed by the handful of drugs and devices that may have been erroneously approved.
This new survey demonstrates that a large majority of orthopedic surgeons believe that the current FDA approval process is already too slow. If that approval process becomes even more drawn out, this situation will worsen.
This is the sixth survey of medical specialists that CEI has conducted. Our first, of oncologists in 1995, demonstrated a high level of dissatisfaction with FDA’s performance. The results of our subsequent surveys have been consistent with these findings. Among the highlights of the new survey are the following:
- over three-quarters, 76%, believe FDA’s approval process is too slow;
- 60% believe FDA hinders their use of new therapies;
- 73% believe FDA approval delays hurt patients;
- 70% favor changing the law to give physicians access to unapproved therapies if they carry a warning about their unapproved status;
- 80% favor having Vioxx available again.
Vioxx was included in the survey even though its withdrawal in 2004 was voluntary. The drug’s continued absence from the market, despite an FDA panel’s recommendation that it be returned, illustrates how needed therapies can be blocked not only by FDA regulations but by liability concerns as well.
While this new survey is consistent with our previous polls, in some respects it represents an exceptionally negative view of FDA. The percentage of those viewing FDA as too slow, 76%, is the highest since our 1995 oncologist poll. The 60% who view FDA as hindering their use of new therapies is the highest recorded in any of our surveys. The same is true of the 58% who report that FDA has hindered their treatment of patients on more than one occasion.
All new therapies carry risks, and sometimes those risks cannot be discovered until after clinical testing. 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.
Competitive Enterprise Institute