A bipartisan group of U.S. representatives called Thursday for changes to the monopoly on sales for insulin drugmakers enjoy in an attempt to curb skyrocketing prices for the vital diabetes treatment.
The report, released Thursday by Reps. Tom Reed, R-N.Y., and Diana Degette, D-Colo., also recommends requiring companies to disclose insulin prices and approving generic versions of insulin much faster.
“The price of insulin has doubled since 2012, which follows a nearly 300 percent increase between 2002 and 2013,” the report said. “Some patients have resorted to rationing and skipping doses.”
Since the discovery of insulin more than 100 years ago, three manufacturers have approved their own brand name form of it and have faced no generic competition, according to the report.
Insulin makers have protected their brand-name formulations by a practice called “evergreening,” through which the company gets a new patent for a slight change to the formulation.
A company could maintain market exclusivity by getting a new patent for only a tiny tweak to the drug’s formula.
“Industry analysts told us that recent insulin innovations appear to be more incremental than past breakthroughs,” the report said.
Some of the report’s policy recommendations would target “evergreening.”
When an insulin maker gets a new patent, it often stops manufacturing older formulas of insulin products, the report said.
“Allowing generic manufacturers to produce these older formulations, as long as they are safe, could expedite the development of a robust and competitive insulin market,” the lawmakers said.
Currently a generic drug must have the same formula as a brand-name drug.
The report added that it could allow generic manufacturers to get faster approval for these older insulin formulas as long as they meet safety and effectiveness standards.
The lawmakers also want brand-name insulin manufacturers to provide more proof that their new formula of insulin is actually a new breakthrough and would improve management of the disease.
“This would ensure that market exclusivity is only given to manufacturers when their improvements to existing insulin formulations are value-based and warrant a patent extension,” the report said.
Other recommendations include new legislation that requires drugmakers to disclose how they set insulin prices and a bill to cap out-of-pocket expenses on drugs needed to treat chronic conditions like diabetes.
Congress will return from its post-election break next week for a lame-duck session for the rest of the year. Some of the recommendations in the report, including changes to the patent system to halt “evergreening,” would likely get major opposition from the pharmaceutical industry.
