Drugmakers’ “Shenanigans” Stifle Generic Competition

The Trump administration and Congress are focusing their attention on brand-name drugmakers that prevent generic competitors from accessing branded drug samples, thereby inhibiting bioequivalence testing that is needed to gain FDA approval of a generic drug.

In November of last year, FDA Commissioner Scott Gottlieb criticized branded drug companies for these types of “shenanigans” aimed at preventing generic competition.  Congress has also long debated, but failed to pass, legislation to address abusive tactics that block entry of generic drugs.  For instance, pending bipartisan legislation — known as the Creating and Restoring Equal Access to Equivalent Samples Act, or CREATES Act — would allow a generic manufacturer to bring an action in federal court to obtain the samples it needs.

Several lawsuits have been filed over similar abuses.  In 2014, generic drugmaker Mylan Pharmaceuticals Inc. filed an antitrust suit against Celgene Corp., accusing Celgene of unlawfully maintaining its monopoly over two of its cancer drugs — Thalomid and Revlimid — by preventing Mylan from obtaining samples of the drugs.  According to the complaint, because of regulatory restrictions on the distribution of Thalomid and Revlimid, Mylan was unable to obtain the samples from normal distribution channels such as wholesalers, and therefore Celgene’s refusal to supply Mylan with samples has foreclosed the generic company from even attempting to enter the market.  That case is ongoing in the District of New Jersey.  

Faruqi & Faruqi has brought similar antitrust suits on behalf of direct purchasers against pharmaceutical companies that engage in anticompetitive practices that forestall generic competition.