- The Washington Times - Thursday, February 28, 2008

Foreign factories that make products destined for American medicine cabinets are inspected far less frequently than U.S. facilities by the Food and Drug Administration.

It’s one of the many problems lawmakers and an FDA advisory group say must be fixed with a drastic increase in funding and resources — more than President Bush has outlined — for the FDA.

The FDA’s Science Board, an advisory group, asserts the agency needs an additional $375 million in 2009, which is much larger than Mr. Bush’s proposed $51 million increase, to help restore the agency.

“FDA needs a very substantial increase in resources if it is to protect us as the public expects and Congress demands,” said Gail H. Cassell, vice president of scientific affairs at Eli Lilly and Co., who led the Science Board subcommittee, in a letter to Congress.

The House Energy and Commerce Committee plans to take up the 2009 FDA budget today in a hearing with Health and Human Services Secretary Michael O. Leavitt.

The hearing comes after a number of public problems at FDA in recent months, including a clerical error that resulted in a Chinese factory not getting inspected, a series of large-scale food recalls and questions over the transparency of celebrity-endorsed prescription drugs.

The disparity between foreign and domestic inspections has been highlighted by four deaths and hundreds of allergic reactions related to the blood thinner heparin, which Baxter Healthcare Corp. made in part with ingredients produced in China. The facility was mistakenly missed by FDA inspectors who confused its name with that of another facility already inspected. The source of the problem hasn’t yet been determined.

On average, foreign medical factories that plan to bring products to the United States are inspected at a rate of once every 13 years, according to 2002 to 2007 figures in a U.S. Government Accountability Office (GAO) report.

American facilities that produce medical products or drugs are required to be inspected every two years per the Federal Food, Drug and Cosmetic Act. There is no similar requirement on the frequency of foreign inspections.

The disparity is even greater when looking at individual countries. The rapidly growing number of Chinese factories sending prescription drugs and medical products to the United States are inspected at a rate of about 2 percent annually, the report says. That means it would take nearly 50 years to inspect all the Chinese facilities if FDA continues at that rate.

Facilities in Switzerland, Ireland and Italy are inspected about once every seven years.

The FDA runs into some trouble doing inspections in foreign countries, the GAO says. The agency does not have a set of foreign inspectors; instead it relies on domestic inspectors to volunteer for the foreign assignments. There are obvious language barriers, as well as requirements for visas in some countries. Plus, the inspectors are often on a tight schedule to inspect a handful of factories during one trip in a specific country.

Reps. John D. Dingell, chairman of the House Energy and Commerce Committee, and Bart Stupak, chairman of the subcommittee on oversight and investigations, proposed a link between the heparin deaths and the FDA not inspecting the foreign plants before prescription drugs are approved.

“These heparin tragedies are likely the result of FDA abandoning its preapproval inspection requirement. A critical policy was put in place two decades ago after a generic drug investigation by this committee,” said Mr. Dingell, Michigan Democrat.

Mr. Dingell and Mr. Stupak, also a Michigan Democrat, said last week they are considering introducing legislation that would require the FDA to inspect foreign and American factories at the same rate. It could mean American factories are inspected less frequently, but that foreign factories are inspected more often.

“Conceptually it makes sense,” said William Hubbard, spokesman for the Alliance for a Stronger FDA and a former deputy commissioner at FDA. “If the requirement is that U.S. drug manufacturers are inspected every two years, and most of our drugs are now coming from foreign sources, it’s logical that you would inspect foreign manufacturers.”

The FDA said it will respond to the legislation if and when it’s submitted.

“Protecting the American people by determining the cause of the problem with the Baxter heparin and addressing that problem is our highest priority,” FDA spokeswoman Karen Riley said. “Any proposed solutions will be evaluated carefully, in light of the root cause, when it is identified.”

The American Pharmacists Association, which represents private-sector pharmacists, says it is critical of imported drugs.

“We see it as the utmost priority of our organization that the integrity of the drug supply is secured,” said Kristina Lunner, vice president of government affairs at the organization. “We rely on the regulators to determine the frequency at which foreign manufacturing plants need to be inspected.”

Some Democratic lawmakers said yesterday that they’re in favor of granting additional funds to the FDA.

The Science Board’s proposal includes increasing the FDA’s budget by $375 million to $460 million each year for the next five years.

“This is the best evidence we’ve seen that the FDA needs a serious infusion of resources if we want to avert catastrophe,” said Rep. Henry A. Waxman,California Democrat and chairman of the House Oversight and Government Reform Committee, of the Science Board report.


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