Amid rising tension between drug makers and compound pharmacies, the Food and Drug Administration has issued new policies that seek to bolster manufacturing standards for compounded medicines and, in the process, may serve to establish competitive boundaries between these rival sets of companies.
A key piece of the effort focuses on a contentious issue: compounded drugs that, essentially, may be copies of prescription medicines. The agency specifies that compounders should not copy FDA-approved drugs, except when shortages exist.
There are two reasons the agency adopted this position. One is safety, because compounded drugs — made by combining, mixing, or altering ingredients of a drug — are held to a lower regulatory standard and are supposed to be given only to patients whose medical needs cannot be met by an FDA-approved drug.
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Anyone concerned about patient health and the cost of prescription drugs should fight this, including payers, insurers, employers, physicians and patients. There are plenty of patients who cannot tolerate some of the additives in prescription drugs, or need different formulations or dosages. Once again, FDA reveals its true colors as an agency more protective of industry interests than patient health. It is captured nearly lock, stock and barrel by the ‘stakeholders’ that benefit from the status quo and tightening the screws to lock down their monopolies, patents and rights to sell dangerous devices that are now banned or withdrawn from sale in other nations given the extent of patient harm.