A new report accuses pharma companies of using FDA’s risk evaluation rules to unfairly block generic competition.
In June, I blogged about accusations that French drug distribution practices were stifling generic competition. At the time, the French Competition Authority admitted that this was largely a French phenomenon – perhaps not as much as they thought…
A new report from the Generic Pharmaceutical Association accuses drug companies of abusing the US FDA’s REMS (Risk Evaluation & Mediation Strategy) to prevent the approval of generic medicines.
The FDA increasingly requires bioequivalence studies before a generic can be launched, comparing it with already launched versions. However, firms are allegedly using REMS to refuse to prevent the purchase of samples, making bioequivalence studies impossible.
Furthermore, manufacturers of branded drugs are accused of expanding these practices beyond the REMS programs, citing things like safety concerns as a reason to prevent supply to generic developers.
The report claims that US healthcare would save around $5.4 billion if generic versions of branded drugs were allowed to come to market. The study was based on 40 products identified in a confidential survey of eight generic manufacturers and conducted from December 2013 to March 2014.
A number of lawsuits have been brought by generic manufacturers who accuse patent holders of blocking the development of generics. In several instances, the Federal Trade Commission has sided with the generic drug makers, citing anti-trust concerns.
In April, the agency ruled against Celgene in a lawsuit brought by Mylan Laboratories over claims it had been blocked from receiving test samples of Revlimid (lenalidomide) and Thalidomid (thalidomide).
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