Hearings highlight how restrictive use programs can limit generic competition

A subcommittee of the House Oversight and Government Reform Committee today held a hearing to examine how drug makers may misuse voluntary restricted distribution systems to delay or block generic competition. Janet Woodcock, M.D., director of the Food and Drug Administration’s Center for Drug Evaluation and Research, said drug makers sometimes use these programs to keep competitors from accessing their drugs for bioequivalence testing, noting that some 150 generic firms have reported difficulties obtaining product for bioequivalence testing to the agency. Also testifying at the hearing were representatives from the Association for Accessible Medicines, Center for Hospital Finance and Management at the Johns Hopkins Bloomberg School of Public Health, and Patients for Affordable Drugs. At a Senate Health, Education, Labor and Pensions Committee hearing yesterday on improving medical product regulation, Sen. Susan Collins (R-ME) said the Special Committee on Aging, which she chairs, found that restrictive use programs can be abused to delay generic entry into the marketplace. According to a report last year from the University of Chicago’s NORC, inpatient hospital drug costs increased more than 38% per admission between 2013 and 2015. Nearly half of the drugs evaluated had no generic competition.