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The Food and Drug Administration (FDA) today is announcing a proposed current good manufacturing practices (CGMP) regulation for the production of Positron Emission Tomography (PET) drugs. The regulation, which establishes minimum standards for the production and testing of PET drug products, is intended to ensure that PET drug products meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, identity, strength, quality, and purity. Concurrently with the issuance of this proposed regulation, FDA is publishing a draft guidance entitled "PET Drug Products - Current Good Manufacturing Practice (CGMP)" which describes acceptable approaches that would enable the PET drug producers to meet the requirements in the proposed regulation.
PET is a medical diagnostic tool in which a radioactive drug is administered to a patient, most commonly by intravenous injection, and the distribution and uptake of the radioactive drug to various bodily organs is imaged using a special camera (also called a scanner). The image helps physicians diagnose diseases such as cancer and heart disease. PET images show biochemical changes of an organ or tissue in the human body, unlike X-ray, CT, or MRI images which show only bodily structures. One PET drug in particular, known as Fludeoxyglucose or [F18] FDG, has been shown to be useful in identifying active tumors, for monitoring the progression or regression of malignancies, and for monitoring the effectiveness of therapeutic interventions. PET drugs have a short half-life, that is, they decay with time and must be used within hours or minutes after production. This characteristic affects how they are produced and as a result, some of the CGMP requirements for traditional pharmaceuticals are not necessary or appropriate for the production of PET drugs.
Originally, PET drug products were produced in academic institutions. Increasingly, however, production of PET drugs has become more commercialized and PET drugs are being reimbursed by private insurance plans.
The FDA Modernization Act of 1997 directed FDA to establish new approval procedures and CGMP requirements for PET drugs taking into account the special characteristics of PET drugs, the operations and processes required to produce these drugs, and any relevant differences between not-for-profit institutions that compound PET drugs for their patients and commercial manufacturers of such drugs. The Modernization Act suspended the requirement that PET drugs be marketed under approved applications until 2 years after FDA established approval procedures and CGMP requirements for PET drugs.
FDA has greatly simplified the approval procedures for some commonly used PET drugs by publishing findings regarding their safety and efficacy upon which PET producers could rely in submitting new drug applications, and publishing guidance that explains in detail how to submit an application. Now FDA is publishing the proposed CGMPs for comment. After the comment period closes, FDA will prepare a final rule that includes responses to the comments. Two years after that final rule takes effect, PET producers will be required to submit new drug applications before marketing a PET drug.
Although not yet required to submit applications for marketing, recently, two PET centers voluntarily submitted and obtained approval to market FDG.
Since the Modernization Act of 1997, FDA has undertaken a careful evaluation of the operations and processes required to produce PET drugs that are safe and effective and of adequate quality. Through a number of public meetings since 1999, FDA has also been very active in seeking comments from patient advocacy groups, professional associations, manufacturers, physicians, and scientists licensed to make or use PET drugs. A Preliminary Draft CGMP Proposed Rule for PET drug products was issued in April 2002. FDA conducted a public meeting concerning it and solicited comments from the public. The proposed rule issued today takes into account the comments received by the FDA since 1999 related to the production and quality control of PET drugs. The proposed rule issued today is intended to ensure that the patient receives a high quality PET drug, regardless of who produces the PET drug or where it is produced.
FDA is providing a 90-day public comment period on the proposed CGMP regulation and draft guidance. FDA seeks public comments to help the agency develop the final rule and guidance.
For additional information, go to http://www.fda.gov/cder/regulatory/pet/default.htm.
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