Biocentury has a look at the issue of compounding pharmacies, which is an area that’s been getting a lot of attention in this era of steep rises in generic drug prices. (You may recall that the competition for T*ring’s Daraprim is coming from a company that’s making the active ingredient available to compounders). The recent call in JAMA for the FDA to do something about these situations also brought in the idea of compounding as a possible remedy. Two previous situations serve as examples – colchicine with URL Pharma and Makena, originally from KV Pharmaceuticals. Both of these got new approvals under the FDA’s program of modernizing the regulatory situation for old compounds, and both saw dramatic price increases).
The problem is, as the Biocentury article notes, that the FDA is not supposed to be considering drug pricing at all. Its mandate is for safety and efficacy – period:
But current and former FDA officials told BioCentury they are wary of the proposals both because of the potential risks to patients from compounding and importation, and because of concerns that giving FDA an explicit role in regulating prices would undermine the integrity of its decisions.
Public trust in FDA is predicated on the belief that it bases decisions on medical and scientific criteria, not on economic considerations.
While only a small number of off-patent drugs fit the pyrimethamine and colchicine profiles — medically important, cannot be easily replaced by other generics, and produced by a single company — public outrage over drug prices is not limited to such products.
Creating a process for FDA to help reduce the cost of such drugs puts the camel’s nose under the tent, raising the possibility that Congress and the White House would pressure the agency to act to lower the price of new drugs. This raises the possibility that FDA could be perceived as prioritizing economic benefits to society over the medical needs of individual patients.
There’s definitely something to that. And this gets to one of several two-incompatible-ideas problems that we have in talking about health care. On the one hand, if you went around asking people if the government should be able to lower the prices of new drugs, I’d bet you’d get a big solid “Yes!” in an opinion survey. But if you asked if the FDA should decline to approve a new drug that might well help patients, just because it’s expensive, you’d probably get a big solid “No!” As it is, every time the agency does anything that can be seen as slowing down a drug approval or rescinding any part of one, people pop up immediately saying “See, I told you. Health care rationing – there it is, right in front of you. Now do you believe me.”
That was the case in 2011, when the agency rescinded a provisional approval for Avastin in breast cancer. It didn’t work in that indication, and the FDA pulled back the approval on those grounds, but there were still plenty of people who were sure that this was all some kind of stealthy cost-cutting effort. So there’s a strong feeling that the FDA should be doing something about costs, and a strong feeling that the FDA shouldn’t be doing anything about costs, and how you reconcile these I don’t know. I think what people imagine is that there’s some sort of world where the FDA approves everything and makes it cheap at the same time. But that’s not going to happen, and I don’t think it should, either.
Update: thoughts from Matthew Herper at Forbes: “The current system is almost guaranteed to cause price increases”.