A bill that aims to fix FDA’s inspection mess has some provisions that don’t make sense and don’t solve problems.

June 1, 2008

3 Min Read
Good Ideas, Bad Execution


Sometimes good intentions lead to bad policy. Unfortunately for the medical device industry, that appears to be the case with the first draft of the FDA Globalization Act, about which Congress heard testimony in May.

After a Government Accountability Office report revealed that FDA is incredibly far behind on its efforts to inspect foreign plants that make medical devices for U.S. consumption, it became clear that reform is needed. At the current level of staffing and funding, it would take 27 years for the agency to get to them all. The numbers for foreign food and drug plants are similarly unacceptable.

The bill would boost funding for the agency's foreign inspection operations and set up some permanent agency offices in foreign lands. These steps are much needed. But some of the other provisions in the first draft of the bill are problematic. They have the potential to place significant burdens on industry and stretch the agency even thinner than it is now.

The most egregious is a provision that would require FDA to conduct preapproval inspections of all Class II devices. Currently, preapproval inspections are required only for Class III/PMA devices.

The thing is, only about 50 PMA devices get approved each year, yet scheduling preapproval inspections for them is a train wreck. Consider what Wally Pellerite, a veteran of CDRH's Office of Compliance, told us in 2005:

“Industry goes through the review process, the scientific questions are answered, and then the district goes out to conduct the inspection. The reviewers routinely find that the firms are not ready. Maybe the firms won't be ready for four to eight months. The manufacturing process is not established to a point where it can be inspected. And then when firms are ready, they expect the district to get right to it… It's a significant issue that places a lot of burden on the districts.”

If the process is difficult to coordinate 50 times a year, consider that more than 3600 Class II devices are cleared each year. Even with the increased resources Congress wants to give the agency, trying to schedule an additional 3600 inspections a year would be a disaster.

The requirement would “bring the FDA approval process to a screeching halt,” AdvaMed president Stephen J. Ubl told the House Energy and Commerce subcommittee during its hearing on the bill. He's right. There is no evidence that the measure would help public health, and there is potential that it could harm public health by delaying patient access to new products. It needs to be dropped from the legislation immediately.

Also problematic is a provision that would require each plant making Class II products to be inspected within two years, regardless of its track record or the level of risk the products produced there. FDA moved away from this strategy for domestic inspections for a reason: It made no sense to inspect low-risk devices as often as high-risk devices, given the agency's resources. This principle holds true even though FDA will likely be getting more resources. Public health is still better served by more-frequent scrutiny of high-risk products. Not all medical devices are created equal, yet the legislation seems to assume they are.

Another stumbling block is language that would impose a broad-based facility user fee to help pay for more-frequent foreign and domestic inspections. In his testimony, Ubl objected to it strenuously. He said funding via user fees could have unintended consequences, such as small device firms with no overseas operations unwittingly funding inspections for larger competitors that do operate overseas. Instead, he said, Congress should create “a targeted funding mechanism for inspections of foreign facilities that are located in countries with less-developed regulatory systems and actually export products to the United States.”

The idea behind the bill is a good one, but parts of it will create more problems than they solve. The medical device industry must let Congress know, loudly and frequently, that those portions need to be scrapped.

Erik Swain for The Editors

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