The House committee on Oversight and Government Reform held a hearing today on REMS, a regulatory tool that has been co-opted by brand name pharmaceutical companies to thwart generic competition. According to the committee's website, the purpose of the hearing was:
To discuss the purpose of using voluntary restricted distribution systems in the pharmaceutical supply chain.
To examine how a manufacturer may use a restricted distribution system to delay or block generic competition.
Almost a year ago, the Senate Judiciary Committee held a hearing on REMS, specifically pertaining to the CREATES Act, legislation that would address the competitive harm of REMS abuse. David Balto, director of The CPPC, wrote a piece for The Hill entitled "Brother May I? Congress must reform senseless drug regulation" to bring light to this somewhat esoteric - but highly consequential - consumer issue.
"The current 'Brother may I' regulatory system forces competitors to ask their rivals for permission to compete. It invites dysfunction and eliminates competition, for which consumers pay dearly. As Maureen Ohlhausen, a Republican Federal Trade Commissioner recently declared, this is 'inconsistent with the free-market principles that ought to guide our economic policies.' The CREATES Act is Congress’s way of saying 'there are no two ways about this.'"
With FDA user fee reauthorization on the horizon in Congress, increased scrutiny is likely to be placed on the process of approving new or generic drugs.