[Congressional Record (Bound Edition), Volume 153 (2007), Part 21]
[Extensions of Remarks]
[Pages 29149-29150]
[From the U.S. Government Publishing Office, www.gpo.gov]




  CLAIBORNE E. REEDER, DISTINGUISHED PROFESSOR OF PHARMACOECONOMICS, 
              CONCERNED ABOUT FDA POSITION ON COMPOUNDING

                                 ______
                                 

                          HON. EDOLPHUS TOWNS

                              of new york

                    in the house of representatives

                       Thursday, November 1, 2007

  Mr. TOWNS. Madam Speaker, I would like to call my colleagues' 
attention to an outstanding letter written by Claiborne E. Reeder, RPh, 
PhD, to FDA Commissioner von Eschenbach, expressing grave concern about 
recent FDA actions which adversely affect the compounding of 
medications for individual patients which is an important part of the 
practice of pharmacy. With 35 years of experience as a Pharmacist and 
educator, Dr. Reeder is a distinguished professor of Pharmacoeconomics 
and a nationally recognized leader in his field. In his letter, he 
urges Commissioner von Eschenbach to reconsider the FDA's position on 
compounding and comply with the federal ruling in Medical Center 
Pharmacy v. Gonzales which recognizes that the practice of Pharmacy is 
rightfully governed by the respective State Boards of Pharmacy.
  Madam Speaker, I am entering Dr. Reeder's letter into the Record.

                                                 Columbia, SC,

                                                 October 19, 2007.
     Andrew C. von Eschenbach,
     Food and Drug Administration,
     Office of the Commissioner,
     Rockville, MD.
       Dear Commissioner von Eschenbach: I am writing to express 
     my concerns about the Food and Drug Administration's (FDA) 
     recent actions regarding compounded medications prepared for 
     individual patients as part of the practice of pharmacy. The 
     agency's position on compounding medications, coupled with 
     its actions against several compounding pharmacies and its 
     intervention and influence on recent Centers for Medicare and 
     Medicaid Services (CMS) policies on compounded medications, 
     establishes a dangerous precedent that will affect patient 
     access to needed medications. Compounding medicines is an 
     essential component of the practice of pharmacy that provides 
     physicians with the opportunity to provide patients with 
     medicines that are prepared to the specific needs of the 
     individual. Compounding and preparing medications pursuant to 
     a valid prescription or physician's drug order has always 
     been and should continue to be a professional prerogative 
     that is governed by the pharmacy regulatory boards within 
     each state. Governance of the practice of pharmacy is a state 
     responsibility and should not be a matter for federal 
     intervention,
       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''. The Federal Court seems to understand the issue 
     very clearly and recognizes that medications compounded for 
     individual patients pursuant to a valid prescription are not 
     ``new drugs'' and are therefore not under the purview of the 
     FDCA or the FDA.
       As a pharmacist/educator with 35 years of experience, I 
     appreciate the FDA's concern for quality, safety and efficacy 
     of medicines. That said, I also know that pharmacists are 
     educated and trained in the ``art and science'' of pharmacy 
     which includes compounding medicines for patients who need 
     them. The broad interpretation ``that all compounded drugs 
     are unapproved new, and therefore illegal drugs'' is a very 
     slippery slope of regulatory intrusion on the practice of 
     pharmacy as is FDA's practice of exercising its enforcement 
     discretion through reliance on the 2002 Compliance Policy 
     Guide, Section 460.200. Many patients have medication needs 
     that are unmet by commercially available products. Patients 
     often require a particular strength or dosage form of a drug 
     that is not available on the market. Also, commercially 
     available products may contain additives or excipients to 
     which the patient is allergic or intolerant. To declare 
     compounded medications illegal is to deny these patients 
     access to needed medicines.
       Compounding medicines is not limited to the typical 
     community environment. Hospitals, skilled nursing facilities, 
     and specialty pharmacy providers prepare medications to order 
     as part of their daily practice. Do the FDA and CMS positions 
     mean that preparation of parenteral and enteral solutions as 
     well as other extemporaneous products, within these settings 
     is no longer legal? If not, then a disparity is created.
       To further illustrate the consequences of the Agency's 
     position on compounding, CMS, without explanation or medical 
     rationale, reversed its long standing policy on inhalation 
     medications by excluding compounded inhalation medications 
     for Medicare beneficiaries stating that they were no longer 
     ``medically necessary''. This new CMS policy, based on FDA's 
     position, may have far-

[[Page 29150]]

     reaching and serious consequences fur Medicare beneficiaries 
     who rely on nebulizer medications. Eliminating compounding 
     will severely restrict access to these and other critical 
     medications for Medicare beneficiaries. Moreover, the policy 
     will limit physicians' abilities to prescribe the medicines 
     in the strengths, formulations, and routes of administration 
     that are best for patient care.
       I am asking that the FDA to reconsider its position and 
     comply with the Federal court ruling. The practice of 
     pharmacy is governed by the respective state Boards of 
     Pharmacy through the powers granted by their legislatures. 
     Compounding is an integral part of the practice of pharmacy 
     and should thus fall under the governance of the profession 
     at the state level.
       Thank you for considering my comments in this matter. If 
     you or anyone at the FDA would like to discuss this issue in 
     more detail, I would be delighted to do so.
           Sincerely,
                                              Claiborne E. Reeder,
     Distinguished Professor of Pharmacoeconomics.

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