Lawmakers Want More FDA Oversight of Imported Medical Devices and CosmeticsMay 15, 2008 | Parker Waichman LLP
Democratic lawmakers say the US Food and Drug Administration (FDA) has insufficient funding and power to maintain appropriate oversight and regulation of imported products, especially medical devices and cosmetics. "While the market for these products becomes increasingly global, the FDA has no requirement to inspect foreign establishments manufacturing medical devices," said Representative Frank Pallone (New Jersey-Democrat) who led a US House of Representatives Energy and Commerce panel Wednesday.
Lawmakers continue to work toward legislation that would require drug and device makers, food manufacturers, and cosmetic companies to register with the FDA and pay for mandatory inspections of foreign factories. The proposed bill follows a flood of tainted goods imported from China, including poisonous pet food, tainted toothpaste, and contaminated medications, such as the blood thinner heparin. Currently, the FDA inspects foreign makers of heart defibrillators and other high-risk devices about once every six years; makers of hearing aids and less risky devices once every 27 years; and US device facilities once every three to five years, according to the Government Accountability Office (GAO).
Some Republicans feel industry fees are like an added tax that would burden manufacturers. Representative Joe Barton—Texas-Republican—said imported devices did not pose the same risks as other products. "We've had major problems with food imports from China, we've had major problems with drug imports from China, but I'm not aware that we've had major problems with medical device imports from China," he said.
Device makers also argue that increased inspections for low-risk products, like contact lenses and glucose meters, would delay those products from reaching patients. "Requiring FDA to conduct pre-approval inspections ... would bring the approval process to a grinding halt," said Steven Ubl, head of the Advanced Medical Technology Association, in testimony to Wednesday’s panel. Also, industry groups questioned more inspection fees for device companies, which already pay the FDA to review products for approval. FDA officials said they are working to increase inspections and create agency offices in other countries.
Stephen Sundlof, head of the FDA's Center for Food Safety and Applied Nutrition, which oversees cosmetics, urged lawmakers to focus on risky products and better use of private inspections. Democrats said the FDA has even less power over cosmetic products, which have gone largely unregulated for decades—the industry is overseen by rules enacted 70 years ago and the FDA has only reviewed 11 percent of related ingredients and banned or restricted 10 types that posed safety risks. About $62 billion in personal products are sold in the US annually and the number of imported products has tripled since 2000 and is expected to grow, said Sundlof who also acknowledged that regulating cosmetics has become a challenge as more products "straddle the line between cosmetics and drugs."
"I think improving oversight authority of cosmetics is long overdue," said Representative Jan Schakowsky (Illinois-Democrat). Sundlof acknowledged only one-third of all US cosmetic makers are registered with the FDA and said companies are responsible for ensuring safety before marketing products. Unlike drugs or devices, cosmetics are not approved by the FDA prior to being placed on the market.