IACP Responds to FDA’s Makena® 17-P UpdateFDA Study Affirms no Major Safety Issues with Compounded 17-P
Late on Friday, the Food & Drug Administration (FDA) distributed a press release summarizing the findings of a multi-month study of compounded 17-P hydroxyprogesterone preparations, a medication to help prevent pre-term labor.
It is important to note that the FDA’s study did not find evidence of safety or purity problems with compounded 17-P which would necessitate enforcement actions or a change in its policy regarding the compounding and dispensing of 17-P by pharmacists.
Here are the key points from the FDA’s release which capture their findings:
FDA has completed its review, and the Agency is now providing a brief summary of the results. FDA collected samples of compounded hydroxyprogesterone caproate products and hydroxyprogesterone caproate APIs. These samples generally were collected from compounding pharmacies, doctor’s offices, API distributors, and APIs offered for importation.
FDA tested 16 samples of hydroxyprogesterone caproate API using the methods specified in the United States Pharmacopeia (USP) as well as the methods used in the Makena new drug application (NDA).
All 16 API samples passed USP tests for potency (97-103 percent) and purity and all 16 API samples passed the potency tests in the Makena NDA.
All 16 of the API samples passed the total purity standard in the Makena NDA but failed the Makena NDA’s limit for unidentified impurities.
FDA also isolated and identified four impurities that appeared at levels above those permitted in the Makena NDA. Based on information available to FDA, the impurities observed in these samples do not raise safety concerns.
FDA also tested 13 samples of compounded hydroxyprogesterone caproate prepared by eight pharmacies.
One of 13 samples was subpotent and was in the range of 80 percent of declared potency. (The standard for potency is 90-110 percent). All 13 of the samples met the standard in the Makena NDA for total purity.
Two of the 13 samples failed to meet the standard for unidentified impurities in the Makena NDA.
IACP Takeaways from the FDA Study:
KV Pharmaceutical has heavily emphasized that the bulk ingredient (API) used by compounders were from unregulated sources. In a November 8, 2011 statement, KV Pharmaceutical stated that their marketing and distribution affiliated company Ther-Rx had conducted a study of compounded 17-P preparations.
Research commissioned by Ther-Rx shows that the API used in compounded 17P formulations originates primarily from facilities in China that are neither registered with nor inspected by the FDA. This research also found that the vast majority of entities claiming to be original manufacturers of hydroxyprogesterone caproate are actually re-packagers, re-sellers, brokers or distributors of hydroxyprogesterone caproate that is actually manufactured in China.
In direct contrast, the recently announced FDA analysis showed that All 16 API samples passed USP tests for potency (97-103 percent) and purity and all 16 API samples passed the potency tests in the Makena NDA. Compounding pharmacies only use APIs sourced from FDA registered facilities, regardless of their location. Of interest, KV Pharmaceutical fails to mention that its own source of 17-P is located outside the United States.
Though only one of 13 samples of compounded 17-P failed to meet potency requirements, the FDA did not identify whether or not that sample was handled or stored properly during the testing procedure. Just last week, on 8 June, the Office of Inspector General issued a report that found that more than 75% of physician offices failed to maintain the appropriate storage requirements for vaccines.
Statement from IACP’s Executive Vice President and CEO David G. Miller, RPh
“Despite attempts by a manufacturer, KV Pharmaceutical, intent on maximizing its profits by casting doubts on the quality and commitment of compounding pharmacists, the FDA’s own independent review confirmed that there were no safety issues with compounded 17-P. Since the introduction of KV Pharmaceutical’s Makena(R) hydroxyprogesterone caproate injection at $1,500 per dose, and despite KV’s cease and desist letters to pharmacists claiming that hydroxyprogesterone caproate/17-P could no longer be compounded now that there was an FDA-approved product, IACP and its Members have steadfastly affirmed that 17-P should still be able to be compounded for patients as it has been done for the past 20 years,” says IACP’s David G. Miller, RPh, Executive Vice President & CEO.
“There are many reasons why a prescriber would choose a compounded alternative over the FDA-approved product – dosage strengths, patient intolerance to excipients, dosing forms, compliance issues, taste, allergies, a continued course of previously initiated therapy – to name just a few. If a prescriber determines that a compounded preparation of a medication is in the best interest of his or her patient and discusses the available options with a pharmacist, there are no statutory or regulatory prohibitions on that professional decision.”
“Patients and prescribers should feel confidence in knowing that compounding pharmacies follow rigorous processes and steps to provide finished preparations that are as sterile and potent as those of a manufacturer.”
The International Academy of Compounding Pharmacists (IACP) is an association representing more than 2,100 pharmacists and pharmacist technicians who focus upon the specialty practice of pharmacy compounding. Compounding pharmacists work directly with prescribers including physicians, nurse practitioners and veterinarians to create customized medication solutions for patients and animals whose healthcare needs cannot be by manufactured medications. More than 163,750 patients and prescribers also belong to our organization via the grassroots advocacy group, P2C2 (Patients and Professionals for Customized Care). IACP’s mission of protecting, promoting and advancing personalized medication solutions is critical for patient healthcare. IACP offers a free Compounding Pharmacy Locator Service which can be accessed toll free at 800/927-4227 or via IACP’s website at http://www.iacprx.org.