FDA Calls for More
Foreign-Drug Inspectors
It seems safe to say that the FDA needs more foreign inspectors in view of the previous [heparin] story. But the Democrooks prefer having a political football to kick around, and the Republicrooks don't want to spend the money, which could otherwise be sent to some deserving rich people. IMO - Doc
Message 24349529
"Congress is in no mood to put money into an FDA that is badly broken and they have no plan."
...
The skepticism of Hill Democrats could leave Dr. von Eschenbach, and the agency he heads, in a catch-22, at least until after the November election.
ASSOCIATED PRESS
February 28, 2008; Page D6
The Food and Drug Administration needs more inspectors and a comprehensive computer database to better track products entering the U.S. from foreign sources, a top drug-safety official told lawmakers.
The FDA focuses its inspections on domestic companies, with about 1,200 inspections conducted annually in the U.S. Meanwhile, only about 300 foreign facilities are inspected each year. The latter number amounts to only about 10% of the firms shipping prescription drugs or their ingredients into the U.S., said Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research.
The small number of foreign inspections seemed particularly relevant during the hearing amid concerns about the blood thinner heparin and its imported ingredients. Two weeks ago, the drug was linked to four deaths and adverse reactions in about 350 patients. Millions of patients take the drug every year to avoid potentially life-threatening blood clots.
Rep. Rosa DeLauro (D., Conn.) chairman of an appropriations panel responsible for funding the FDA, said the agency hadn't inspected a Chinese factory that may be a source of problems with Baxter International Inc.'s blood thinner heparin. She noted that the FDA intended to inspect the manufacturer of an ingredient in the drug, but apparently inspected the wrong factory, and the wrong firm was entered into the FDA's database. She called the case embarrassing, adding the agency's work seemed motivated by ideology and hampered by incompetence.
Dr. Woodcock said the FDA was still the gold standard that other countries tried to model. She said a series of well-publicized drug-safety problems over the years can be partly attributed to the agency getting much better at finding problems.
Lawmakers continually asked Dr. Woodcock what additional resources she needed. She said if she could get more resources, the top two priorities would be to hire more investigators and upgrade the agency's computer systems.
FDA officials said President Bush's 2009 budget recommended enough funding for an additional 31 full-time employees, on top of the 232 investigators now in the field, but they acknowledged that substantially all of the money would come from higher user fees that haven't been approved.
In November, the Government Accountability Office -- the investigative arm of Congress -- found the FDA doesn't know how many foreign firms are subject to inspection. The agency has a list of 3,249 firms that it uses to prioritize which ones should be inspected. But at the current rate of inspection, it would take the FDA more than 13 years to go through each firm on its list. The agency can't say how many foreign firms have never been inspected.
Rep. Jack Kingston (R., Ga.) said he disagreed with Rep. DeLauro's description of the agency. He said it was his impression that the FDA has struck the proper balance between safety and getting drugs to the market that can help patients. "I don't think there is a safety crisis in America," he said.
online.wsj.com |
