A high-profile Republican senator wants to include potential Food and Drug Administration reforms intended to lower drug prices within a larger legislative package next year.
“There is clearly a greater role for the FDA here,” said Sen. Susan Collins, R-Maine, chairwoman of the Senate Special Committee on Aging, which held the first bipartisan Senate hearing on high generic drug prices Wednesday.
But which FDA reform package is another question, as Collins didn’t say it would be part of the Senate’s efforts to draft its own version of the 21st Century Cures Act. That bill passed the House earlier this year and contains new money for medical research and reforms to get drugs to market much faster.
“We are looking at the House-passed bill, but we are also looking more broadly than that,” she said.
She said any reforms targeting prices hopefully would be part of a larger package next year, which means it probably would not be included in efforts in 2017 to reauthorize user fees for medical devices and pharmaceuticals.
Collins sits on the Senate Health, Education, Labor and Pensions Committee, which is drafting the Senate version of the cures act.
Collins and several senators at the hearing said they liked a potential solution: a new pathway that would allow the FDA to approve certain generic drugs within six months, much faster than the current time frame of more than a year.
The pathway would be used selectively and to directly combat a spate of high-profile cases of drug prices that have skyrocketed.
Normally, generic drugs are low-cost alternatives that hit the market after the patent for a brand name drug expires, but several companies have acquired decades-old drugs and raised the prices. Most notoriously is Turing Pharmaceuticals, which raised the price of an anti-parasite treatment by 5,000 percent from $13.50 a pill to $750 last summer.
The reason that could happen is lack of competition.
Sen. Claire McCaskill of Missouri, the committee’s top Democrat, said such a pathway would give companies such as Turing “a small window to skim the cream, so to speak, and rip people off.”
The pathway wouldn’t be for all generic drugs.
“The priority review would be triggered if there were little or no price competition for that generic drug,” Gerard Anderson, professor at Johns Hopkins Bloomberg School of Public Health, said at the hearing.
He added that an agency besides the FDA should do the economic evaluation, since the FDA doesn’t traditionally take into account prices when making its drug-approval decisions.
The next hearing in the Senate committee’s investigation could delve deeper into possible solutions the FDA could implement.
Collins said the committee ultimately intends to call for testimony from CEOs of Turing, Valeant and other companies that have raised prices such as Retrophin and Rodelis. However, she did not give a timeframe for such a hearing or whether the committee would need to issue subpoenas.
“It is too premature to talk about that,” she told reporters.
A frequent target at the hearing was Turing CEO Martin Shkreli, who McCaskill referred to as “Mr. Wu-Tang.” McCaskill was referring to Shkreli’s recent $2 million purchase of a secret album of the hip-hop group Wu-Tang Clan.
Shkreli caused more controversy when he said during a recent Forbes healthcare summit that he would raise the price of the anti-parasite drug Daraprim even more.
