[Congressional Record (Bound Edition), Volume 153 (2007), Part 27]
[Extensions of Remarks]
[Page 36466]
[From the U.S. Government Publishing Office, www.gpo.gov]




ARTHUR I. JACKNOWITZ, PROFESSOR AND DISTINGUISHED CHAIR, DEPARTMENT OF 
        CLINICAL PHARMACY CONCERNED ABOUT CMS COMPOUNDING POLICY

                                 ______
                                 

                          HON. EDOLPHUS TOWNS

                              of new york

                    in the house of representatives

                      Wednesday, December 19, 2007

  Mr. TOWNS. Madam Speaker, I would like to call my colleagues' 
attention to a compelling letter written by Arthur I. Jacknowitz, 
Pharm. D, Professor and Distinguished Chair in the Department of 
Clinical Pharmacy at West Virginia University's School of Pharmacy at 
the Robert C. Byrd Health Sciences Center in Morgantown, WV. Writing on 
behalf of more than 650 pharmacies and 359,000 Medicare beneficiaries 
in West Virginia, Professor Jacknowitz expressed his deep concern over 
the adverse impact that CMS's new policy excluding compounded 
inhalation medications from Medicare beneficiaries would have in West 
Virginia and across the Nation.
  Madam Speaker, I ask unanimous consent to enter Professor 
Jacknowitz's letter into the Record.
                                         West Virginia University,


                                           School of Pharmacy,

                                 Morgantown, WV, October 30, 2007.
     Kerry Weems, Administrator,
     Centers for Medicare and Medicaid Services, 200 Independence 
         Avenue, SW, Room 314 G, Washington, DC.
       Dear Administrator Weems: Compounding pharmacists play an 
     essential role in many patients' lives by enabling physicians 
     to prescribe customized medication therapy to best meet their 
     needs. Indeed, for the growing number of people with unique 
     therapeutic requirements that cannot be addressed with 
     commercially available products, a compounded product may be 
     the only viable treatment option.
       Compounding of medications for patient use has been a 
     significant component of the practice of pharmacy and 
     medicine since the beginnings of our profession. Virtually 
     all practicing pharmacists will be involved with compounding 
     activities at some point during their career. In fact, it is 
     estimated that the 30 to 40 million prescriptions are 
     compounded each year. Pharmacists are the only health care 
     professionals that have studied chemical compatibilities and 
     can prepare alternate dosage forms. In fact, each state 
     requires that pharmacy schools must, as part of their core 
     curriculum, instruct students on the compounding of 
     pharmaceutical ingredients. Compounding pharmacies are 
     licensed and regulated by their respective state boards of 
     pharmacy, rather than the FDA.
       With this mind, I am writing to you as a Professor of 
     Pharmacy and on behalf of more than 650 pharmacies and 
     359,000 Medicare beneficiaries they serve in our state of 
     West Virginia to express my concern about the Center for 
     Medicare and Medicaid Services (CMS) new policy excluding 
     compounded inhalation medications from Medicare 
     beneficiaries. CMS issued this new policy without explanation 
     or medical rationale driven by the Food and Drug 
     Administration's (FDA) posture and legal position regarding 
     compounding. It is a reversal of your agency's long-standing 
     policy on inhalation medications. By excluding compounded 
     inhalation medications for Medicare beneficiaries stating 
     that they are no longer medically necessary you are 
     discriminating against compounded medications in general. I 
     believe that this new policy may have far-reaching and 
     serious consequences for Medicare beneficiaries who rely on 
     nebulizer medications. Eliminating compounding will severely 
     restrict access to these critical medications for Medicare 
     beneficiaries and their prescribing physicians.
       The FDA's legal position on compounding medications, its 
     aggressive enforcement policies against several compounding 
     pharmacies and the agency's intervention and influence on 
     CMS's recent policies on compounded medications establishes a 
     dangerous precedent for all pharmacy compounding throughout 
     the United States. Ignoring the recent Federal court decision 
     Medical Center Pharmacy v Gonzales. 451 F. Supp.2d 854, 865 
     (W.D. Tex. 2006), the FDA reasserted its legal position 
     ``that all compounded drugs are unapproved new, and therefore 
     illegal, drugs under the Federal Food, Drug and Cosmetic Act 
     (FDCA)''. Contrary to the FDA's position, the Federal Court 
     held that ``compounded drugs, when created for an individual 
     patient pursuant to a prescription from a licensed 
     practitioner, were implicitly exempt from the new drug 
     definitions contained in the Act''.
       As a result of the FDA's position and CMS's new policy on 
     compounding, more than 29,000 citizens of West Virginia 
     suffering from Chronic Obstructive Pulmonary Disease (COPD) 
     that depend on these medications as well as the hundreds of 
     compounding pharmacies and their employees, will be adversely 
     affected. For this reason, I am asking that CMS rescind the 
     recent policy excluding compounding medications.
       Thank you, for you consideration.
           Sincerely,

                                         Arthur I. Jacknowitz,

                                Professor and Distinguished Chair,
     Department of Clinical Pharmacy.

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