A Medical Device Daily
A senior lawmaker charged that FDA commissioner Andrew von Eschenbach isn't doing his job and hasn't requested enough money to inspect overseas drugmakers.
Rep. John Dingell (D-Michigan), who is chairman of the House Energy and Commerce Committee, pointed his finger at von Eschenbach and repeatedly asked him how much it would cost to do more inspections. Dingell objected when the commissioner didn't provide specifics.
Dingell and other lawmakers said the FDA must conduct more inspections of companies sending drugs to the U.S. to ensure they are safe. Lawmakers cited deaths and allergic reactions linked to contaminated versions of the blood-thinner heparin from China and described other tainted products, including toothpaste, that were shipped to the U.S.
"You cannot do your job, you are not doing your job,'" Dingell told von Eschenbach, who was a witness at the hearing before the energy and commerce panel's investigations subcommittee. "You simply are absolutely incapable of addressing your responsibilities."
Von Eschenbach said the FDA is doing more overseas inspections than ever before, although he agreed with lawmakers that still more are needed. He repeatedly said the U.S. must take other actions as well, adding that more frequent inspections wouldn't have detected the tainted heparin.
"In addition to addressing the need to increase our inspections we also need to overhaul the entire system," von Eschenbach said.
The FDA is trying to improve the safety of drug imports by increasing collaboration with regulators overseas and stationing agency employees in China and other countries, he said.
The FDA currently conducts annual inspections of about 7% of overseas drugmakers that ship to the U.S., a pattern suggesting it would take 13 years to visit them all, according to the Government Accountability Office (GAO). Domestic firms are inspected an average of once every 2.7 years.
At least 80% of all active ingredients used by U.S. manufacturers to produce drugs are imported, according to lawmakers.
The FDA has 3,249 overseas drug manufacturers on a list that it uses to plan its inspections, according to the GAO. Inspecting those plants every two years would cost the agency at least $67 million annually, according to the GAO. The FDA plans to spend about $11 million this year for all overseas pharmaceutical inspections.
In order to inspect the roughly 714 Chinese plants that that are registered to ship products to the U.S., the FDA would have to spend at least $15 million annually, according to the GAO.
Eighty-one people in the U.S. given heparin died since January 2007 after suffering allergic reactions, according to the FDA (Medical Device Daily, Feb. 13, 2008).
The FDA has said it didn't inspect a plant in China that made the main ingredient in Baxter International's (Deerfield, Illinois) heparin, which was found to be contaminated. The agency said it confused records on that facility and another with a similar name. Baxter and its supplier say the contaminant must have been added earlier in the supply chain, before the products reached their factories.
Von Eschenbach told lawmakers that even if an inspection had taken place, the contaminant wouldn't have been found because conventional tests couldn't have detected it. The FDA has since asked drugmakers to use a test that can pick up the contaminant, he said.
The FDA plans to station employees in three Chinese 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.
FDA clears new examination glove material
The FDA has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, made by Yulex (Maricopa, Arizona), is derived from the guayule bush, a desert plant native to the Southwestern U.S.
Traditional latex gloves are made from the milky sap of a rubber tree, Hevea braziliensis. The sap contains a protein that may trigger allergic reactions, especially after prolonged and repeated contact. Sensitized people may experience mild reactions such as skin redness, rash, hives, or itching. More severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, shock may occur.
Estimates vary, but anywhere from 3% to 22% of all healthcare workers are sensitized to traditional latex.
Available data on the new guayule latex show that even people who are highly allergic to traditional latex do not react on first exposure to guayule latex proteins.
"This approval has the potential to make a significant difference to both the general public and the medical community at large," said Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health. "Gloves made from guayule latex may prove to be a safer alternative for some people with sensitivity to traditional latex. And yet they will not sacrifice the desirable properties of traditional latex such as flexibility and strength."
Because there is no data on people's long-term experience with the Yulex glove, the product will carry a warning for now about the potential for allergic reactions.