US Congress tackles FDA device, cosmetic oversight

U.S. Democratic lawmakers seeking to bolster Food and Drug Administration oversight of imported products took aim at medical devices and cosmetics on Wednesday, saying the agency lacks the money and power to properly regulate them.

The FDA is especially squeezed as the United States imports a growing number of catheters, heart devices, soaps, shampoos and other items, members of a U.S. House of Representatives Energy and Commerce panel said at a hearing.

“While the market for these products becomes increasingly global, the FDA has no requirement to inspect foreign establishments manufacturing medical devices,” said Rep. Frank Pallone, a New Jersey Democrat who led the panel.

The FDA inspects foreign makers of heart defibrillators and other so-called high risk devices every six years on average, while makers of hearing aids and other less risky devices are checked an average of every 27 years, according to the Government Accountability Office.

Device facilities in the United States are inspected an average of every three to five years, the GAO said.

Wednesday’s hearing comes as lawmakers consider sweeping legislation that calls for 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 comes after a rash of tainted goods imported from China, including pet food, toothpaste and the blood-thinning drug heparin.

While both Democrats and Republicans generally support efforts to empower the agency, several Republicans likened industry fees to an added tax that would burden manufacturers.

Rep. Joe Barton, a Texas Republican, also 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.

Representatives for device makers said more oversight was unnecessary. Greater inspections for less risky products, such as contact lenses and glucose meters, would keep products from getting to patients quickly, they said.

“Requiring FDA to conduct pre-approval inspections ... would bring the approval process to a grinding halt,” Steven Ubl, head of the Advanced Medical Technology Association, said in testimony to the panel.

Industry groups also questioned additional inspection fees for device companies, which already pay the FDA to review products for approval.

FDA officials told lawmakers they have taken steps to increase inspections and set up agency offices in other countries, among other efforts.

Stephen Sundlof, head of the FDA’s Center for Food Safety and Applied Nutrition, which oversees cosmetics, urged lawmakers to focus their legislation on more risky products and make greater use of private inspections.

COSMETICS UNCHECKED

Democrats said the FDA has even less power to monitor lotion, make-up and other cosmetic products that have gone largely unregulated for decades.

Roughly $62 billion in personal products are sold in the United States each year, Sundlof said. The number of imported products has tripled since 2000 and is expected to grow, he added.

Yet the industry is largely overseen by rules established 70 years ago. Since then, the FDA has looked at 11 percent of related ingredients and banned or restricted 10 types that posed safety risks.

“I think improving oversight authority of cosmetics is long overdue,” said Rep. Jan Schakowsky, an Illinois Democrat.

Sundlof acknowledged that just one-third of all U.S. cosmetic makers are currently registered with the agency, adding that companies are responsible for ensuring safety before marketing their products.

Unlike drugs or devices, cosmetics are not approved by the FDA before they are sold.

Pamela Bailey, head of the Personal Care Products Council industry group, said current law was strong enough, but urged lawmakers to give the FDA more money to carry out its duties.

FDA’s Sundlof said regulating cosmetics has become a challenge as more products use sophisticated ingredients and “straddle the line between cosmetics and drugs