Sunday, March 23, 2008

Tainted Drugs Put Focus on the FDA

Tainted Drugs Put Focus on the FDA

By Gardiner Harris

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Washington - After a contaminated medicine from China was linked to as many as 17 deaths in the United States, members of Congress clamored for changes while regulators defended their actions.

The drug was a common antibiotic, and the year was 1999. But in recent weeks, the Food and Drug Administration has faced an almost identical crisis.

Nineteen deaths have been linked to contaminated heparin, a crucial blood thinner manufactured in China. Again the drug agency became aware of the problem only after hundreds were sickened. Again Congress is investigating.

The FDA admitted that it violated its own policies by failing to inspect the China plant, and on Friday it said it had alerted border agents to detain suspect heparin shipments.

"This heparin problem has happened before with other drugs," said William Hubbard, a former FDA deputy commissioner, "and it's going to keep happening until Congress fixes this problem."

The Institute of Medicine, the Government Accountability Office and the FDA's own Science Board have all issued reports saying poor management and scientific inadequacies make the agency incapable of protecting the country against unsafe drugs, medical devices and food.

Indeed, in the years since the last China drug scandal, the share of drugs coming from that country has soared while the FDA's inspections of overseas drug plants have dropped. There are 566 plants in China that export drugs to the United States, but the agency inspected just 13 of them last year.

The agency does not have the money to inspect many more, and the Bush administration has no plans to fix this most basic of problems. The administration's budget calls for a 3 percent increase in allocated funds next year, not enough even to keep up with rising costs.

Congress, though, may finally heed the calls of Mr. Hubbard and others and allocate far more money. The Senate passed a budget resolution on Friday to give the FDA an additional $375 million, a 20 percent increase over this year.

"Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the FDA," said Senator Edward M. Kennedy, Democrat of Massachusetts, who pushed for the new financing.

Several top legislators in the Senate and House said they supported the increase.

"FDA needs a serious infusion of resources and strong leadership dedicated to reforming the agency," said Representative Henry A. Waxman, Democrat of California, who is chairman of the House oversight committee.

Representatives John D. Dingell and Bart Stupak, powerful Democrats from Michigan, said they would fight to support the increase in the agency's budget.

But the new money is far from assured. President Bush has threatened to veto appropriations that go beyond his requests, and there are powerful interests in Congress that are skeptical of increased agency financing.

Among the skeptics is Representative Rosa DeLauro, Democrat of Connecticut, who leads the House appropriations subcommittee with authority over the agency. Ms. DeLauro said that although the FDA was in crisis, "I don't want to throw money at an agency that doesn't have the infrastructure to carry out its mission."

Some top agency officials are simply "incompetent," she added, and real change can occur only with a new administration.

An FDA spokeswoman, Julie Zawisza, said the agency was "looking at a number of options in addition to more foreign inspections to increase our presence abroad and our ability to detect problems." For instance, the agency is opening an office in China to conduct audits and inspections.

The uncertain prospects of the increased financing have led many in Congress to consider a user-fee system to pay for foreign inspections. The agency already relies heavily on user fees to pay for new drug reviews. Mr. Stupak said such a system might be the only way to pay for the necessary inspections of an industry rapidly moving to places like China.

"Why should the taxpayer pay for these inspections so that you can close a plant here and open it over there to ship it back?" Mr. Stupak said. "It will be sustainable income so that we don't have to get into these budget battles every year."

Eighty percent of the active pharmaceutical ingredients of drugs consumed in the United States are manufactured abroad; 40 percent are made in China and India. Meanwhile, the FDA has cut back on its foreign drug inspections, which declined to 341 in 2006 from 391 in 2000.

Among the only foreign inspections that the FDA still conducts are those done before a drug's approval. Spot foreign inspections are rare. For logistical reasons, the agency warns foreign plants when its inspectors intend to visit, something not done domestically. All of this needs to change, said Mr. Stupak, who wants the oversight of foreign plants to be as strict as those governing domestic ones.

Dr. Sidney Wolfe, director of Public Citizen's health research group, said a fee-based inspection system was "a terrible idea" because it would lead the agency to become more lax with those who pay their salaries.

"The FDA is too important to be left to the industry to fund it," Dr. Wolfe said.

Manufacturers would support a user-fee system in hopes of making medicines safer and competition fairer, said Guy Villax, chief executive of Hovione, a drug maker based in Portugal with plants in Europe, the United States, China and Macao.

Plants in China and India are rarely inspected by Western governments, which can reduce costs dramatically, Mr. Villax said. Even the Chinese did not inspect the plant making contaminated heparin because, regulators there said, everything made at the plant was shipped overseas.

"The globalization of active pharmaceutical ingredients has happened very quickly," Mr. Villax said, "and the government agencies are very slow at adapting to changing circumstances."

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