US FTC issues opinion favoring generics makers' initiative to address drug shortages

The USA’s Federal Trade Commission's Bureau of Competition staff has issued a positive advisory opinion letter for the country’s generic drugmakers, in response to a request from the Generic Pharmaceutical Association (GPhA), stating that the staff will not recommend a challenge to an initiative intended to help the US Food and Drug Administration respond to the unprecedented increase in shortages of critically important medications.

The proposed program, called the Accelerated Recovery Initiative (ARI), would provide the FDA with information that GPhA believes will enable the FDA staff "more efficiently and effectively to accelerate the recovery of critical drugs in short supply." The staff letter explains that a key element of the ARI is an agreement among drug manufacturers to pool competitively sensitive production information about shortage drugs. As a result, the ARI would raise substantial antitrust concerns if this information were shared among competitors, because such information could facilitate collusion among drug manufacturers.

ARI unlikely to harm competition