Hobbs: ‘Regulating Compounding Pharmacies Should Be Key Patient Safety Plank in FDA Bill'
WASHINGTON D.C. (July 26, 2007) – Eamonn Hobbs, President & CEO of AngioDynamics (NASDAQ: ANGO), released the following statement on the need for Congress to act now through the “must pass” FDA bill to regulate mass-producing compounding pharmacies:
“As Congress continues consideration of FDA legislation, S 1082/HR 2900, it is critical Members work to include a key patient safety plank: new authority for the Food and Drug Administration (FDA) to take action against rogue mass-marketing compounding pharmacies and to require physicians to inform patients about whether their prescribed compounded drugs are FDA approved.
“In recent years, the FDA has worked tirelessly to crack down on numerous compounding pharmacy manufacturers whose products have been found to contain impurities and dose and concentration inconsistencies. In an FDA paper published in May 2007, ‘Special Risks of Pharmacy Compounding,' the agency noted it knows of more than 200 adverse events involving 71 compounded products since 1990. Yet, the FDA needs more authority.
“Earlier this year, bipartisan draft legislation by Senators Edward Kennedy, Richard Burr and Pat Roberts was circulated to strengthen the FDA's role in overseeing compounding pharmacies as de facto manufacturers. The Kennedy-Burr-Roberts proposal has widespread support from Consumers Union and other consumer groups. Regrettably, the bill's opponents – led by the compounding pharmacy manufacturers' lobbying group, the International Academy of Compounding Pharmacists – are working hard to prevent the measure from even seeing the light of day.
“As the process continues, policymakers should draw a distinction between legitimate and traditional patient-specific pharmacy compounding and mass-producing compounding pharmacies. Compounding pharmacies that are acting as de facto manufacturers should be held to comparable standards through the FDA to ensure that physicians have access to the safest, most effective drugs for their patients. At a time of great attention around drug safety, American consumers deserve nothing less.”
AngioDynamics, Inc. is a leading provider of innovative medical devices used by interventional radiologists, surgeons, and other physicians for the minimally invasive treatment of cancer and peripheral vascular disease. The Company's diverse product line includes market-leading radiofrequency ablation systems, vascular access products, angiographic products and accessories, dialysis products, angioplasty products, drainage products, thrombolytic products, embolization products and venous products. More information is available at www.angiodynamics.com.
Joseph Gersuk, CFO, 800-772-6446 x1608
EVC Group, Inc.
Jennifer Beugelmans/ Doug Sherk
EVC Group, Inc.