FDA needs $70 million more per year to inspect foreign drug plants: Commissioner von Eschenbach.

WASHINGTON -- FDA needs about $70 million more per year to overhaul the agency's overseas drug inspection structure so that the approximately 3,000 overseas drug facilities could be inspected every two years, Commissioner Andrew von Eschenbach, M.D., stated under heated questioning at an April 22 hearing by the House Energy & Commerce Oversight and Investigations subcommittee.

Rep. John Dingell (D-MI), who chairs the full committee, heaped massive criticism on von Eschenbach for not requesting more financial resources from Congress to better protect American consumers from contaminated drug and food products from China and other offshore locations.

Members of Congress including Dingell have blasted FDA for poor inspections of Chinese drug factories since contaminated heparin from China has been linked to as many as 81 deaths. The agency currently inspects foreign facilities about once every 13 years.

"I want to maintain my respect for you but I can't maintain my respect for you if you keep toe dancing around the hard facts that curse you with the inability to do your job because you don't have resources," Dingell told von Eschenbach.

Von Eschenbach, in several appearances before congressional committees, has declined to specifically seek more money for beefed-up foreign inspections.

The commissioner stated that FDA previously had thought that $11 million for 2008 and $13 million for 2009 allocated for inspections was enough for it to inspect the thousands of currently uninspected facilities abroad that import food and drugs into the U.S. every year. The entire current U.S. budget for inspecting overseas drug makers isn't even large enough to check all of the plants in China every two years.

Federal law mandates the FDA inspect domestic drug plants at least every two years. However, no law dictates how often the agency should inspect foreign facilities that export drugs to the United States. But given the high profile cases lately involving tainted heparin from China, Congress is coming under pressure to better protect consumers from imported drug products.

FDA would have to spend at least $15 million annually to inspect every two years the 714 Chinese plants registered to ship products to the U.S., according to the Government Accountability Office (GAO). China has the largest number of plants registered to send drugs to the U.S.

To handle this additional number of inspections, about 500 more FDA investigators would have to be sent overseas. In China, FDA plans to station employees in three cities--Beijing, Guangzhou and Shanghai--to inspect food and drug facilities and assist the country's regulators, von Eschenbach said at the hearing. One FDA employee will begin a temporary assignment in China next month, according to the agency.

Dingell cited statistics showing FDA inspections of U.S. facilities about every 2.7 years; Eschenbach agreed that it would take his agency more than 30 years to inspect every facility in China alone.

Von Eschenbach also said that merely adding inspections would not solve all the agency's problems.

"It's not just a dollar figure multiplied by the number of overseas facilities," von Eschenbach said. "I'm trying to discuss with you that I don't believe that will be a solution to the problem. It's much more complex than that."

Subcommittee Chairman Bart Stupak (D-MI), also a frequent critic of FDA, said: 'If FDA would do something concrete and say, Well increase our inspections, and we'd like you to give us the money,' and tell us how much, we'd find a way to make it happen now."

Marcia Crosse from GAO said during testimony that FDA databases do not allow the agency to correctly identify all the foreign facilities "subject to inspection." She added that the number of foreign inspections, while increasing, still fall far short, and that the agency needs more personnel.

"Given the growth in foreign drug manufacturing for the U.S. markets and the current large gaps in FDA's foreign drug inspections, FDA will need to devote considerable resources to this area if it is to increase the rate of inspections," Crosse said "However, FDA's plans currently call for incremental increases that will have little impact in the near future."

FDA is working to implement a new program called "beyond our borders" that von Eschenbach said could be completely in place within five years.

It calls for a more cooperative effort between FDA and foreign officials and includes sharing foreign inspection reports, opening FDA offices abroad, certifying third-party inspectors and helping foreign regulators understand FDA standards.

"FDA is implementing, and will continue to implement, the action plan for import safety, but this is only a start," said von Eschenbach. "The agency will learn and adapt as we move forward as part of the larger, ongoing agency transformation into an FDA of the 21st century."

After the April 22 hearing, aides to Sen. Charles Grassley (R-IA) noted that von Eschenbach has not yet responded to an offer of help from Grassley, the ranking Republican on the Senate Finance Committee.

On March 11, Grassley wrote von Eschenbach, asking for his opinion on collecting new user fees from foreign-based and domestic drug makers who register with his agency to pay for more foreign drug-plant inspections.

Grassley noted that though there are only 3,000 foreign pharmaceutical manufacturing facilities registered with the FDA, other databases suggest that roughly 6,800 are exporting products to the U.S.

"If registration fees were collected from the approximately 6,800 facilities currently importing products to the U.S. market, FDA could raise more than $11.6 million," which would double the current FDA budget for foreign inspections, Mr. Grassley said.

This past week, an FDA spokesman said in an email the agency is still "developing its response" to Grassley and "cannot implement new user fees without new authority."

Grassley said in a statement that "FDA's assessment on exactly what it will take to get on top of foreign inspections is urgently needed."

Grassley noted FDA recommended registration fees for medical-device makers, which later were incorporated into legislation. "Why won't FDA weigh in on the same question for pharmaceutical manufacturers?" he asked.

A new bill proposed in the House Energy and Commerce Committee would do just that, extending those fees to foreign-device makers while instituting new registration fees for both foreign and domestic drug makers. Democrats say it could generate $600 million from device makers, and perhaps another $500 million from drug makers.

By Joseph Pickett, Managing Editor