+1 212 318 2000
Europe, Middle East, & Africa
+44 20 7330 7500
+65 6212 1000
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.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).