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FDA Needs More Money and More Ideas
FDA can’t accomplish its mission on its present budget. Besides more money, it also needs to evaluate whether changes in its processes could help.
March 1, 2008
3 Min Read
FROM THE EDITORS
It is no longer a question whether FDA has the resources to accomplish its mission. It does not. This message was brought home again in late January, with the release of a report by the Government Accountability Office (GAO). It concluded that CDRH is so far behind on its inspections of foreign plants that produce medical devices for the U.S. market that it would take 27 years to get to them all. The backlog for foreign food and drug plants is similarly shocking.
The agency is so far behind in computer technology that it cannot track how many foreign plants there are, nor can it produce a list of those that need to be inspected. This is particularly a problem in China, where the number of medical device plants has grown sharply in recent years, and more and more of them are starting to produce exports to the United States. Over a six-year period, the agency inspected all of 64 medical device plants in China, yet there are believed to be at least 700 of them.
The GAO report comes on the heels of a report by FDA's own Science Board that concluded the agency cannot keep up with the growing number of imports, and thus cannot guarantee that they are safe for U.S. consumers. (MD&DI had more on that story in the NewsTrends section of last month's issue.)
Since 1987, the agency has lost 1311 employees. The talent drain and high turnover rate among scientists are reasons why the agency is having trouble keeping up to speed on emerging technologies. And more attrition is coming: A number of long-time agency employees are expected to retire rather than endure the aggravation of moving when the agency's new White Oak facility in Silver Spring, MD, is fully up and running.
Adjusted for inflation, FDA's appropriation from Congress is $300 million less than it was in 1987. Yet, since that time, Congress has passed more than 100 laws expanding or redefining the agency's responsibilities.
The math doesn't add up. If you tell an agency to do more things with less money, fewer people, and inadequate technology, you shouldn't be surprised when it does a poor job and scandals such as the Guidant defibrillator fiasco happen.
Something has to change.
Not surprisingly, more people are starting to notice the agency's plight. Reaction to President Bush's proposed fiscal year 2009 budget for the agency was mixed at best, as most of the increase comes from user fees. The Alliance for a Stronger FDA, an advocacy group formed from the merger of the FDA Alliance and the Coalition for a Stronger FDA, was particularly vocal. The group suggested adding $380 million to the president's proposal. Peter Barton Hutt, a former chief counsel for the agency, went further, telling Congress that FDA's appropriation should be doubled and its staff increased by 50% over the next two years.
It is clear that FDA does not have enough money for its mission. Much thought must be given to what it would take to ensure that it does. But because funding resources are finite, the debate should not end there. Much thought must also be given to what exactly the agency's mission should be, and which, if any, tasks it performs now can be streamlined or eliminated. For example, a CDRH inspection has requirements that go beyond those in ISO 13485, which is used by much of the rest of the developed world. Do they really make us that much safer than patients in Europe or Canada? Imagine the cost savings that could happen if the United States used the same inspection system as its Western counterparts. And shorter inspection time means that more plants, domestic and foreign, get inspected in a timely manner. I'm not saying this is the route FDA needs to go, but it's the kind of thing that needs to be considered. It's obvious the status quo isn't working. The agency not only needs to be revitalized, it also needs to be reengineered.
Erik Swain for The Editors
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