A new report by the Senate’s bipartisan Special Committee on Aging asks Congress to take steps to prevent exorbitant price increases for older prescription drugs with no competition.
The report, based on a yearlong investigation, features case studies of four drugmakers: Turing Pharmaceuticals, Retrophin, Rodelis Therapeutics and Valeant Pharmaceuticals International. All four companies bought marketing rights to off-patent, sole-source drugs used to treat relatively rare conditions—some of them life-threatening—and then promptly raised the price of the drugs, in one case by more than 5,000 percent. Such increases can place treatment out of reach, even for insured patients.
In each case, the drugs were considered the gold standard treatment, had only one manufacturer, had lost patent exclusivity decades ago, and were unattractive to potential competitors. None of the four companies had invested in the drugs’ development.
Among the steps the committee recommended are enactment of a law that would expedite FDA review of certain generic drug applications, to promote competition and improve patient access; ensuring that drugmakers interested in developing generic versions have access to samples of the original branded drug; allowing temporary drug importation in certain situations where there are sudden, dramatic price increases in off-patent drugs; and preventing the misuse of patient assistance programs and copay coupons, which drug companies sometimes use to steer patients toward higher-priced drugs.
The report notes that price gouging frequently occurs with commonly used drugs as well, and that greater transparency in drug pricing strategies, drug distribution practices and funding of (and by) pharmaceutical companies could help prevent unwarranted price spikes across the board.