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Sen. Tom Harkin (D-Iowa) and 13 other senators May 6 sent a letter to the Food and Drug Administration urging the agency to do everything in its power to end a severe shortage of drugs used to treat critically ill infants.
Hospitals throughout the country have reported that the shortage is disrupting infant care, and several institutions have said they are within one to two weeks of running out of these essential products, the senators said in a statement. Several hospitals have been forced to reduce or ration these products.
Products in short supply include sodium phosphate, potassium phosphate, calcium gluconate, calcium chloride, zinc, trace elements, and several others, according to the letter.
“Drug shortages are unacceptable in any circumstances--but even more so when they pose a threat to vulnerable infants,” Harkin, chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, said. “The FDA must do all it can to end these life-threatening drug shortages and give parents, children, and medical professionals the peace of mind they deserve.”
In the letter to FDA Commissioner Margaret A. Hamburg, the senators said they “understand that at least one manufacturer of these products is currently offline and is working with you to get back on the market.”
“We ask that you do everything in your power to get these products back on the market quickly and safely,” the letter said.
In addition to Harkin, the letter was signed by Sens. Al Franken (D-Minn.), Pat Roberts (R-Kan.), Lamar Alexander (R-Tenn.), Sherrod Brown (D-Ohio), Rob Portman (R-Ohio), Michael Bennet (D-Colo.), Tim Scott (R-S.C.), Amy Klobuchar (D-Minn.), Michael Johanns (R-Neb.), Elizabeth Warren (D-Mass.), Johnny Isakson (R-Ga.), Mark Kirk (R-Ill.), and Robert P. Casey Jr. (D-Pa.).
The House Oversight and Government Reform Committee also has been looking into the issue of drug shortages. On March 18, leaders of the committee sent a letter to FDA asking for documents and other information on how the agency handles generic drug shortages (56 HCDR, 3/22/13). The leaders said they have concerns about how FDA is handling shortages of generic injectable drugs, given that the number of drug shortages has increased by 10 percent over the past year.
That letter was signed by Rep. Darrell E. Issa (R-Calif.), chairman of the House committee. It also was signed by Reps. Jim Jordan (R-Ohio), Trey Gowdy (R-S.C.), James Lankford (R-Okla.), and Paul A. Gosar (R-Ariz.). Jordan is chairman of the Subcommittee on Economic Growth, Job Creation, and Regulatory Affairs; and Lankford is chairman and Gosar is vice chairman of the Subcommittee on Energy Policy, Health Care, and Entitlements.
In March, stakeholders submitted comments to FDA on ways the agency can prevent or lessen the impact of drug shortages (52 HCDR, 3/18/13). Drug companies suggested that FDA identify and publish a list of “critical drugs” and require manufacturers to maintain an inventory of these drugs.
The consumer group Public Citizen suggested that drug shortages would be alleviated if FDA strengthened its enforcement of compounding pharmacies. Meanwhile, a hospital group suggested that FDA and Congress collaborate with the pharmaceutical industry to identify appropriate incentives that would encourage drugmakers to establish manufacturing redundancies and invest in their quality systems.
By Bronwyn Mixter
The Senate letter is at http://harkin-press.enews.senate.gov/common/mailings/index.cfm?id=2998.
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