The International Contrast Ultrasound Society (ICUS)
Shortages of certain prescription drugs, particularly chemotherapy drugs, have created a public health crises, forcing clinicians to scramble to find life-saving medications for their patients.
In January 2012, legislation was introduced to ensure access to information related to drug shortages to compliment an improved early warning system for the FDA. And more recently, legislation to reauthorize the Prescription Drug User Fee Act (PDUFA) contains a provision to bring critical shortage drugs to market faster via a shortcut for proving manufacturing compliance.
Under the PDUFA legislation, to prevent or alleviate shortages of life-sustaining drugs, the HHS secretary may deem major manufacturing changes in compliance with good manufacturing practices (GMPs) if a drug maker can at least implement adequate interim controls and demonstrate that it has a plan and enough resources to achieve full compliance.
Lantheus Medical Imaging. The drug shortage situation has not been limited to cancer drugs. In an April 13th call with members of the ICUS Board, Lantheus CEO Don Kiepert explained that the manufacturer of DEFINITY®, Ben Venue Laboratories, has been experiencing challenges in meeting production demand for the products they produce, including DEFINITY®. According to Kiepert, BVL has not yet re-started production of DEFINITY®; and DEFINITY® will go on back order from mid-April until the time at which (a) BVL can release new quantities of DEFINITY® or (b) Lantheus’ new contract manufacturer, Jubilant HollisterStier (JHS) can begin commercial production of DEFINITY®.
Lantheus informed members of the ICUS Board that the company expects that at least one and possibly both of their production partners will be manufacturing DEFINITY® during summer, 2012, but that temporary shortages are nevertheless expected to occur.
For a copy of the letter Lantheus has sent to health care providers discussing supply challenges, please click here.
GE Healthcare. In a May statement to ICUS, GE Healthcare stated that the company secured additional supply of its ultrasound contrast agent, OPTISON®, from their current contract manufacturer, Covidien. Also, in an effort to strengthen their supply chain to make sure stock is available for patient needs, GE announced plans to manufacture OPTISON® internally at its plant in Oslo, Norway.
For a copy of the GE Healthcare Statement to ICUS Members, please click here.
The ICUS Board believes that access to ultrasound contrast agents is critical to patient care because contrast-enhanced ultrasound imaging provides a safe, reliable, cost-effective and radiation-free option for diagnosing medical abnormalities.