Lawmakers introduce bill to end REMS abuse, boost generic competition
- A new bill introduced by members of the Senate Judiciary Committee could limit the ability of drugmakers to block generic competition by restricting a drug's distribution, reports Stat.
- Called the Creating and Restoring Equal Access to Equivalent Samples Act, the legislation seeks to curb abuse of an FDA program which asks drugmakers to monitor distribution of new drugs with potential safety concerns.
- While requiring risk evaluation and mitigation strategies (REMS) is aimed at improving safety, some have voiced concern drugmakers can use it as an excuse to block generic companies from obtaining samples of certain drugs—necessary for developing generic copies.
Generic drug makers have claimed that their ability to copycat brand name drugs is often compromised by brand name drug manufacturers denying access to needed samples under the guise of REMS restrictions.
Bill sponsors have pointed to the case of much-maligned Turing Pharma, which infamously bought the drug Daraprim (pyrimethamine) from Impax Labs and immediately increased the price to $750 per pill from $13.50.
Turing then limited distribution even though the FDA had not required a REMS plan, hindering generic drugmakers ability to create generic versions of the drug.
Attempts to reform the REMS program have been tried before, in slightly different iterations. A year ago, the Fair Access for Safe and Timely (FAST) Generics Act had been floated as a possibility.
This new version of the bill goes further in its efforts to ensure fair competition. Whereas FAST focused only on companies with REMS plans, this bill is directed at any company which denies samples to a generics company. According to Stat, the secretary of health and Human Services could then vet the request for samples.
"Pharmaceutical companies should be compensated for their important work developing life-saving treatments, but when companies engage in predatory practices at the expense of consumers, we must act," said Senator Patrick Leahy, a sponsor of the bill.
Leahy has been joined by Senators Chuck Grassley (R-IA), Amy Klobuchar (D-MN), Mike Lee (R-UT) and plans to hold a hearing on the bill in front of the Senate Judiciary Committee.