Senators mull speedier generics pathway amid outrage over Turing, Valeant price hikes
- At a Senate committee hearing Wednesday, senators discussed creating a priority review pathway for FDA approval of generic drugs entering markets with no existing competition. Singling out Turing Pharma's Daraprim, Republican and Democratic senators alike expressed anger and frustration over recent price hikes for off-patent drugs.
- Witnesses at the hearing, held by the Senate Special Committee on Aging, agreed that relying on compounded medications did not present a long-term solution for providing alternatives in the face of price hikes for off-patent drugs.
- Dr. Erin Fox, director of Drug Information Service at University of Utah Healthcare, testified that sharp price increases for the heart meds isoproterenol and nitroprusside led her organization to pull the drugs from more than 100 crash carts in their system.
Across both parties, Senators generally disapproved of the aggressive pricing tactics used by Turing and Valeant. Both companies have faced significant backlash in recent months.
Committee chair Sen. Susan Collins (R-ME) concluded the hearing with a sharp rebuke. "I find it so disturbing and unconscionable that a company would buy up a decades old drug...and then would hike up the price to such egregious levels that it is having an impact on patient care," she said.
The hearing was called in response to recent price hikes of older drugs by companies like Turing and Valeant and featured a proposal to speed up the entry of generic competition. Gerard Anderson, a health policy professor at Johns Hopkins University, proposed giving the FDA authority to grant priority review for generic competitor drugs entering a market with no competition.
Some older drugs like Daraprim have long been off patent, yet have only one manufacturer because of small patient populations. Generic competitors don't see any advantage to entering the market when it will take more than two years for any generic competitor to clear the FDA approval process, Anderson argued. While the process itself only takes six months to a year, there is a long queue of drugs waiting approval. He proposed giving the FDA authority to place generic competitors entering these markets to the top of the waitlist.
Sen. Bob Casey (D-PA) agreed this idea could be a potential solution while a number of others, including Collins and Sen. Tom Cotton (R-AR) also appeared interested.
Notably, the two physicians on the witness panel both believed compounding did not provide a sustainable workaround to higher drug prices for off-patent drugs. Pharmacy benefits manager Express Scripts turned to Imprimis Pharmaceuticals for a $1-a-pill compounded Daraprim alternative in recent weeks.
The hearing also touched on the hard choices hospitals now face when considering how to budget for suddenly expensive off-patent drugs. Valeant's price increases for isoproterenol and nitroprusside meant the University of Utah would have to pay nearly $2 million dollars more to stock the drugs, for instance.
Faced with a potentially huge hole in their budget, Fox and her team decided to pull the two heart meds from more than 100 crash carts throughout the university system. While doctors would still have access to these therapies through pharmacy back-up boxes, the drugs would no longer be readily available.
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