Compounding Pharmacy Openly Flouts FDA Regulations
[Posted on: Thursday, October 26, 2017] This week a San Diego based compounding pharmacy, Imprimis, announced that it would compound copies of an approved drug product sold by Allergan at a significantly reduced cost. The same company had last year announced that it would compound copies of Daraprim, another FDA approved drug, also to reduce prices. It would seem great that a company wants to reduce prices of drugs, but there is a problem. Both the announcements are for illegal activities. A compounding pharmacy is not allowed to create exact copies of approved drug products under The Compounding Quality Act, passed in Jan 2016. There are two ways one can legally create copies of an approved drug product. You can make an exact copy and get approved as a generic drugs under an ANDA application, or you can make modifications to the approved product and get approved as a new drug under the 505(b)(2) pathway. Imprimis does not seem to follow either. A search on FDA’s website finds that Imprimis holds no approved drugs similar to the ones they announced. Rather the company is listed as a compounding pharmacy with four locations; and all four locations have been found to have cGMP deficiencies. They do have a disclaimer that “No compounded medication is reviewed by the FDA for safety or efficacy. Imprimis Pharmaceuticals does not compound copies of commercially available products.” However, they are very open about compounding copies of FDA approved drugs, in violation of the Compounding Quality Act. On the website of the company, it invites patients to suggest additional formulations it can compound, and make news releases about the same. So far it seems FDA has not asked Imprimis to refrain from this practice. It is possible that there are ongoing internal communications between the company and FDA, but the brazen announcements by the company indicates otherwise. The company openly promotes its “approach” to create copies of expensive FDA approved drugs in seemingly clear violation of the laws. One wonders why has FDA not done anything about it. FDA has been very vocal recently about high drug prices, but it is hard to envision FDA turning a blind eye to violators of the law to lower drug prices. FDA frequently uses enforcement discretion in case where there is minimal risk but potential benefit to patients. Is this one of those instances? The hardest question for a regulatory expert is when a client points to an act by their competition that seems obviously illegal, with no consequences. It discourages other companies to do the right thing. If a compounding pharmacy can simply compound copies of FDA-approved drugs, then why would any other company attempt to formally create a generic version or even 505(b)(2) versions. Companies like Imprimis have made their business to flaunt the law openly and its time FDA clarifies why it is not doing anything about it.
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