Failure to Fund Foreign Inspections

US health officials are pushing a plan to allow outside inspectors to monitor the safety of imported pharmaceutical ingredients, but a similar programme to inspect foreign-made medical devices has largely floundered.

Food and Drug Administration Commissioner Andrew von Eschenbach recently requested an extra $275m for the agency's 2009 budget, in part to allow quicker entry for imports certified by private parties. He also called on Congress to allow the FDA to more broadly use inspections done by independent third parties.

The FDA has come under fierce criticism from Congress and others for failing to inspect overseas manufacturers after recent massive recalls of the blood-thinning drug heparin, tainted pet food and toothpaste from China.

Agency officials say they lack funding and staff to inspect the growing number of foreign facilities that make drugs and other FDA-regulated products for Americans. US plants are inspected every 2.7 years versus every 13 years for foreign ones, according to the Government Accountability Office (GAO).

While nearly 80% of ingredients used in US prescriptions come from China and India, according to the FDA, in 2007 just 83 plants in those countries were inspected.

But critics say a multimillion-dollar programme to boost inspections with private, third-party inspectors for imported and US-made medical devices has been a failure.

"They spent a lot of money, and they got no customers," says National Research Center for Women & Families president Diana Zuckerman. "If we are going to have third-party inspections, there are ways to make them a lot better than they are for devices. They have been so far a complete and utter failure."

Under the medical device programme, it took the FDA two years to approve the first private inspectors that companies can hire to check their facilities. Since then, 12 third-party inspections have been conducted, according to Daniel Schultz, head of the FDA's Center for Devices and Radiological Health. Another 158 have jointly been conducted with the FDA.

Schultz said the agency is working to entice device makers to use the programme. "The incentives that we thought were there obviously are not enough," he told Reuters.

DRAFTING LEGISLATION

In autumn of 2007 the Bush administration announced a plan to expand non-FDA inspections to prescription drugs and other imported products. Inspections would be voluntary for products considered to be less risky.

The idea is circulating in Congress, where Democrats such as Sen. Edward Kennedy of Massachusetts and Rep. John Dingell of Michigan are drafting bills. Whether legislation ultimately will call for such a programme is unclear. It is also uncertain whether a bill can be passed this year given Congress' limited time ahead of the national election.

To FDA officials, the need for a helping hand is clear.

"It's very difficult to see how we could actually cover the entire globe," Janet Woodcock, head of the agency's Center for Drug Evaluation and Research, told Reuters. "If you consider many of these other plants aren't really inspected at all, putting in some type of programme would be better than not covering them."

Even with third-party inspections, the FDA would still make its own checks of finished medicines, Woodcock says. If Congress agrees to the extra $275m, the FDA said it would use some of the funds to conduct an additional 1,000 inspections abroad and 1,000 in the US.

Like the device programme, outside facility reviews would face some of the same hurdles to convince companies to pay for their own inspections rather than rely on the government.

FINANCIAL ISSUES

With relatively few FDA-approved private inspectors, they are able to charge exorbitant fees, says Medical Device Manufacturers Association Executive Director Mark Leahey.

"These third parties are coming back with prices that seem so out of whack with the services they're providing," he says. Faced with high prices, many of his group's members "just wait for FDA to come around".

Consumer advocates like Zuckerman say such financial arrangements are also ripe for bribes and other schemes. Instead, Congress should beef up the FDA's funding so it can conduct its own inspections, they argue.

"It's better for the public to have the FDA doing it, not to have these companies that have various different incentives," Zuckerman said.

Lawmakers are considering boosting FDA inspection funds, but the agency must compete with funding for the war in Iraq and other federal budget priorities.

Even if the FDA were to get a cash infusion, problems with its antiquated computer systems and unwieldy staff organisation still abound, others say.

Carl Nielsen, a consultant and head of FDA's import operations from 1999 to 2005, said the agency must change to give its foreign inspectors a greater voice within the agency. "Right now, it's a mess," Nielsen said. Even with those changes, the FDA may have no choice but to rely on some outside inspectors for drugs and other products.

"There's still room for third party (inspections). I don't think its an 'either/or,"' Nielsen added. "There are places around the world the FDA is never going to go to and doesn't need to go. I think it's a mix, but the role has to change – it cannot be business as usual."