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Dr.Gooberman's New Drug Application
On May 26, 1999, Dr. Gooberman met with staff from the Division of Anesthetic, Critical Care and Addiction Products at the FDA. The purpose of this meeting was to explore the toxicological and clinical requirements necessary to obtain marketing approval for the use of depo-naltrexone in pellet form for subcutaneous implantation in patients undergoing opiate detoxification. In that meeting, Dr. Cynthia McCormick, the Chief of the Division of Anesthetic, Critical Care and Addiction Products, referred to the enactment of Section 503A in 1997. She specifically advised Dr. Gooberman that current law allows him to prescribe compounded product for his own patients and that approval of an NDA is required only for commercial marketing of a drug. Thus, Dr. Gooberman's decision to pursue FDA approval was entirely voluntary. Nonetheless, Dr. Gooberman has initiated the process for clinical evaluation of the naltrexone pellets for the purpose of seeking a NDA for this indication.
FDA advised Dr. Gooberman that he should conduct some animal studies to support his marketing application. This is a standard requirement for NDAs, and does not indicate that FDA believes animal testing was necessary before prescribing compounded naltrexone. Dr. Gooberman has retained an expert to help him prepare the protocols for these animal tests.
During the meeting, FDA also asked that Dr. Gooberman use a CMP-compliant manufacturing facility to make the naltrexone for the animal studies. Dr. Gooberman has identified two potential manufacturers. He has been in negotiations with them to reach an agreement under which they would supply the materials for these preclinical tests. It must be emphasized that Dr. Gooberman is not undertaking these steps -- preclinical testing and reaching an agreement with a supplier of preclinical trial materials -- solely to support the FDA approval process. They are not necessary to compound under the FDC Act or New Jersey law.
Dr. Gooberman has begun pursuing an NDA based on the interest of colleagues and his own conviction that the drug represents a public health benefit. The NDA process is time-consuming and expensive. While he hopes to interest a commercial partner in bringing the product to market, the initiation of this process demonstrates and extraordinary personal and financial commitment to expand the availability of this medication on the part of Dr.Gooberman, one that goes far beyond what physicians customarily do.
Conclusion
In conclusion, pharmacy compounding is legal under both Federal and New Jersey State law. Federal law provides that compounded drugs are exempt for the NDA, GMP and certain labeling requirements if they are compounded for individually identified patients in accordance with specific criteria that are designed to ensure the safety and effectiveness of compounded drugs. A drug compounded in accordance with those restrictions is exempt from the NDA, GMP, and labeling requirements that govern drug manufacturers, and does not need to be supported by clinical data.
Dr. Gooberman's practice of prescribing compounded depo-naltrexone in pellet form for use in individual patients for opiate detoxification is consistent with the safety and efficacy criteria established by Congress for compounded medications. Therefore, he is exempt from any obligation under federal law to conduct clinical trials to further assess the safety and efficacy of the compounded drug. His voluntary efforts to seek NDA approval for the drug demonstrates his commitment to ensuring that the drug is made available to a broader population of patients, and his willingness to meet a more demanding standard.
Compounding is likely to grow in clinical importance in the near future.
Requiring that physicians possess clinical data before compounding would mean that residents of New Jersey would be deprived of the significant medical benefits offered by pharmacy compounding.
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