Provisions of FDA Globalization Act of 2008 Draft (Related to Devices)
o FDA inspection of foreign and domestic facilities every two years.
o Device labeling that indicates the country of manufacture.
o Unique identification numbers for device facilities and importers, which would identify parties involved in a crisis sooner.
o A dedicated foreign inspection staff to monitor foreign facilities.
o Closing or consolidation of FDA field labs or district offices prohibited.
The recent contaminated heparin scandal has drawn attention to FDA's handling of foreign facilities and imported products. Congress is considering legislation proposed by Representative John Dingell (D–MI) that would hold FDA to certain facility inspection requirements and call for country-of-origin labels on devices. The question is whether Congress will give FDA additional funding to perform the expanded duties outlined in the bill.
The FDA Globalization Act of 2008 would affect the food, drug, cosmetics, and device industries. Hearings are being held to discuss the draft legislation. Although the requirements for device manufacturers are not as lengthy as those for food and drug companies, they would still have to deal with labeling and inspection issues.
One area of ambiguity for devices relates to product labeling. Device labels would have to display the country of manufacture, and unique identification numbers would be assigned to facilities and importers. The draft isn't as specific as the proposal for drugs, in which manufacturers would be required to label where each ingredient was made.
Morgan says that FDA's definition of country of origin and how subcomponents of devices are handled will be key.
Congress has to give FDA reasonable inspection goals and proper funding, says Gibbs. Otherwise its expectations are hypocritical.
“As far as the labeling, whenever you're talking about country-of-origin labeling, the devil will always be in the details,” says Rick Morgan, managing partner at Bowman & Brooke LLP (Minneapolis). “Is it where [the device] is assembled? Is it where parts are from? It'll be interesting to see how country of origin is defined, and how subcomponents of devices are handled for country-of-origin requirements.”
The draft also proposes the creation of an up-to-date registry of all device facilities that service U.S. customers. Companies operating in the United States or exporting products here would need to register with FDA each year and pay a fee that covers agency inspections. Commercial importers of devices would pay an annual registration fee of $10,000, according to the draft.
FDA would also be required to inspect foreign and domestic facilities every two years, and manufacturers wouldn't be able to introduce a device into interstate commerce until an initial inspection occurred. The current law requires an inspection every two years, but it only applies to domestic facilities.
Questions have been raised about the realistic nature of the inspection goals, along with how funding (or lack thereof) will affect these efforts.
“FDA is supposed to have been doing biennial inspections already for certain products, and they haven't been,” says Jeffrey Gibbs, attorney at Hyman, Phelps & McNamara PC (Washington, DC). “All of the reports have talked about how Congress has underfunded FDA for years. Without funding, it seems that telling FDA that it has to inspect drug and device companies every two years is hypocritical [and] irrelevant.”
Morgan has a tough time believing that FDA would be able meet the targets outlined in the draft, especially when it comes to foreign inspections. “It's been pretty clear in the past that FDA has not been able to meet congressional targets for domestic inspections of Class II or Class III device manufacturers,” he says.
The legislation also proposes a dedicated foreign inspection team that involves increasing the agency's capacity to monitor foreign facilities. FDA's field labs and district offices would be prohibited from closing or consolidating, as well.
It's too soon to tell whether the proposed legislation will pose a burden on the device industry, because hearings are still being held. However, funding will be a major issue if the bill keeps the inspection requirements in place.
“Given what's happened with [imports from] China and with heparin, and with other materials that have come in from other countries, I fully understand the need to have tighter controls and have more-frequent inspections as well,” says Gibbs. “I just think it's very important that Congress, when it does strive for those laudable goals, does it in a way that's plausible and achievable, as compared with just telling FDA to do something that can't be done.”