Hooked - (Stacia Naquin)
Updated: 10/11/2013 - I'm SO CLOSE to being able to do a pull-up. So my trainer introduced something new into my training.
House members chastised the Food and Drug Administration on Tuesday for not doing more inspections of foreign drug manufacturers in the wake of a litany of problems with the blood thinner heparin and other products.
“Last year, this nation’s regulatory failures resulted in dead dogs and cats,” said Representative Bart Stupak, Democrat of Michigan. “This year, it has tragically led to the deaths of people. If we don’t make some rapid progress on fixing the foreign drug inspection program, the next melamine or heparin tragedy will soon be upon us.”
Concerns about the inspection program were recently highlighted when the F.D.A. learned that contaminated doses of heparin had probably come through a Chinese plant that the agency had never inspected. Federal officials said Monday that the contaminated heparin was clearly linked to severe reactions now associated with 81 deaths in the United States.
In the last fiscal year, the agency conducted only 30 inspections of the more than 3,200 foreign drug companies, according to government auditors. It plans to conduct at least 50 this year.
Commissioner Andrew C. von Eschenbach told a subcommittee of the House Energy and Commerce Committee that he had asked the administration for more money to conduct inspections, but he did not specify how much. He agreed that more inspections were needed, but not to the lengths Democrats suggested, which is to inspect every foreign company every two to three years.
“I don’t believe that’s the solution to the problem,” Mr. von Eschenbach said. “It’s much more complex, and the solution needs to be much more comprehensive than simply inspecting a facility.”
Representative John D. Dingell, Democrat of Michigan and the committee chairman, said he was tired of hearing from Food and Drug Administration commissioners about conducting business in new, innovative ways in place of additional financial resources. He said commissioners had talked about the need for the agency to be leaner and meaner. But, Mr. Dingell said, it has turned out that it is leaner, weaker and less capable of doing its job.
Representative Joe L. Barton, Republican of Texas, said ballpark estimates from Republican aides indicated that the F.D.A. would need 500 more inspectors to get to the point where foreign companies were inspected with the same regularity as domestic companies. The Government Accountability Office said the cost of such regular inspections would be about seven times the current budget, or about $70 million annually.
Mr. von Eschenbach said the F.D.A. needed to make greater use of independent companies or foreign regulators to certify that drug companies had good manufacturing systems.
Republican members of the subcommittee were in agreement with Democrats that the lack of foreign inspections was a big problem.
“We have already heard the numbers that show the imbalance in risk priorities, with most domestic firms inspected about every two years,” said Representative John Shimkus, Republican of Illinois. “But literally hundreds of foreign firms that have not seen an inspection, if at all, in a decade. Clearly these priorities need to be brought closer into balance.”
The Government Accountability Office said Tuesday that the F.D.A. was making progress in conducting more inspections of foreign drug makers, but still inspected relatively few facilities.
About $10 million has been dedicated for foreign inspections this year.
The drug agency plans to establish foreign offices in three Chinese locations — Beijing, Shanghai and Guangzhou. Later, it will consider setting up locations in India, the Middle East, Latin America and Europe.
Mr. von Eschenbach said 13 employees would be assigned to China to staff the three offices. Eight would come from the United States. Five would be local residents more familiar with the country’s customs, language and business practices.
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