Reuters
On Wednesday, members of the Special Committee on Aging heard health experts speak out sharply against price gouging in which companies acquire older drugs with no generic competition and suddenly raise their price.
Notably missing from the panel of witnesses - which focused mainly on actions by Valeant and Turing Pharmaceuticals - were the companies that have done so. Martin Shkreli, the CEO of Turing, said in a tweet Wednesday that while he had not been called on, he "would have loved to insult Congress."
Even without his presence, inside jokes weren't hard to come by. For her part, Sen. Claire McCaskill (D-Missouri) referred to Shkreli as "Mr. Wu-Tang"; other senators referred to CEOs who've price gouged as "hedge fund folks."
Hearing from those affected by Shkreli's price hikes
At the hearing, Dr. David Kimberlin, who specializes in pediatric infectious disease at the University of Alabama at Birmingham, spoke of a situation in September, around the time Daraprim's price went up after Turing bought the rights to the drug, in which he found barriers to getting the drug because the monthly cost for four tablets suddenly spiked to $3,000 from $54.
Because babies infected with toxoplasmosis, a parasitic infection that can be deadly in infants and in adults with weakened immune systems, have to take Daraprim for a full year, increasing dosage along the way, that cost was suddenly prohibitive for some of his patients.
Kimberlin also told the committee that he had heard of at least 30 cases in 21 states in which doctors and patients had trouble accessing Daraprim, though he didn't specify whether these cases had occurred after Turing slightly revised its pricing strategy.
2 possible solutions
The hearing boiled down to two solutions to the market failure that happens when there's no generic competition for off-patent drugs that are used by relatively few patients.No. 1: Compounding pharmacies
One centered on the use of companies that can offer low-cost alternatives without developing a separate generic drug. One such "compounding" pharmaceutical company, Imprimis Pharmaceuticals, was able to provide a $1-per-pill alternative to the $750-per-pill Daraprim.
Imprimis provides a version of pyrimethamine, the active part of Daraprim, combined with leucovorin, a form of B-vitamin folic acid that's recommended to treat toxoplasmosis.
But across the board, the hearing witnesses seemed wary of using this as a long-term solution.
"Compounding is essential for some patients," Fox said. "But compounding should not be a blanket one-size-fits-all solution. I really don't think it's a solution for many patients."
Mark Merritt, the CEO of Pharmaceutical Care Management Association, the trade association that represents pharmacy benefits managers like Express Scripts, which recently partnered with Imprimis to provide its compounded version of Daraprim at a cheaper cost, made it very clear that he would rather see generic competition than compounded versions.
"We've got to figure out what's the alternative," he said before proposing pathways for generics to get approved. "In the interim, we'll do more compounding and allow that to occur. Then we might have to take a look at taking it in from another market."
No. 2: Generics
Generics appeared to be the preferred way to fix the lack of competition for new drugs.
Merritt cited a backlog among approval for generic drugs at the FDA as one of the reasons that many drugs don't face generic competition just yet. He suggested coming up with a faster approval timeline for generics coming to market to take on drugs with high prices.
Merritt also suggested compiling a definitive list of all the drugs like Daraprim that look ripe for acquisition. The Senate members seemed to enjoy that idea.
"Let the word go out to investors and hedge funds: We're paying attention to this practice," McCaskill said in closing remarks. "If it is a matter of making a list of the off-patent drugs, I think that's a really good idea."
Committee members have until December 21 to submit more questions for the record.