Analysis: Ron Paul is Right About the FDA

Published September 8, 2011

In a debate hosted on MSNBC last night, Ron Paul was singled out repeatedly for criticism by NBC anchor Brian Williams for a number of libertarian views of the proper role of government in society. At times, Williams’ objections just seemed petulant – as if TSA agents were the first line of defense against terror, or as if FEMA, which notoriously dropped the ball just a few years ago in response to Hurricane Katrina, could do no wrong. This was not an exception but the rule for Williams’ questioning throughout the evening, so it’s not as if Paul had it any better than the others.

But there’s one area in particular where his line of questioning of Paul, the only physician on the stage, struck me as ignorant and wrongheaded: Williams’ argument on the loving, protecting arms of government around your medicine. Here’s the transcript of the exchange (emphasis mine), and note that Williams asks for 30 more seconds for a “devil’s advocate” response – as if he is one of the candidates debating instead of a neutral moderator:

WILLIAMS: Over to Congressman Paul, you’re known as the absolutist in the bunch, someone who has consistently opposed federal government from having any role — and I think by your definition — that isn’t explicitly laid out in the Constitution. So this makes people curious: Is there a line with you? Where do you draw it? Does this include things like making cars safe, making medicine safe, air traffic control controlling the jets above our heads?

PAUL: I think in theory, if you understood the free market in a free society, you don’t need government to do that. We live in a society where we have been adapted to this, and you can’t just drop it all at once, but you can transition away from it. On regulations, no, I don’t believe in any of these federal regulations, but that doesn’t mean I don’t believe in regulations. The regulation of the marketplace takes care of it. Just think if we had the regulations on the market that dealt with the bankruptcies? They’d have had to go bankrupt. We wouldn’t have been able to bail out the big banks and the big corporations and dump onto poor people. So the market would dictate it. You can’t commit fraud. If you need detailed regulations, you can do it at the state level. But the federal government is not authorized to nitpick every little transaction. The way they use the interstate commerce clause is outrageous, as far as I’m concerned.

WILLIAMS: Well, 30 seconds more for devil’s advocate here, because would you then put it on the drug companies to say, “No, we’re bringing this to market, trust us, it’s a fantastic drug”? All the pilots in the sky, to add to their responsibilities, their own air traffic control, in an organic way?

PAUL: What I said is, theoretically, you could — it could be privatized. But who ends up doing the regulations on the drugs? They do as much harm as good. They don’t take good care of us. Who gets — who gets to write the regulations? The bureaucrats write the regulations, but who writes the laws? The lobbyists have control, so lobbyists from the drug industry has control of writing the regulations, so you turn it over to the bureaucracy. But you would have private institutions that could become credible. And, I mean, do we need the federal government to tell us whether we buy a safe car? I say the consumers of America are smart enough to decide what kind of car they can buy and whether it’s safe or not, and they don’t need the federal government hounding them and putting so much regulations on that our car industry has gone overseas.

In this line of argument, it’s stunning how ignorant Williams is of the bureaucratic reality we face with drug policy decisions within the Food and Drug Administration. The exorbitant cost of research and development for new drugs is driven largely by the demands of the FDA, which requires rafts of testing and retesting. These policies delay lifesaving treatments for Americans who desperately want them, often for reasons and side effects which threaten only a miniscule portion of the population. As Robert Goldberg pointed out in a recent piece:

Though new and faster methods to determine a technology’s safety and effectiveness exist, Obama’s FDA still demands evidence collected with science and statistical methods developed in the 19th century. To be sure, in the last two years new medicines for AIDS, cancer, lupus and hepatitis have been developed.

Yet, these products should have been available sooner if not for FDA nitpicking. And now that they are finally approved, patients are finding it next to impossible to access several new drugs and genetic tests that would transform the quality of life and extend survival for such illnesses as lupus, prostate cancer, and organ transplantation.

Provenge, the first cancer vaccine, stalled at the FDA for years. Once approved, it faced 18 months of additional delay while the Obama administration figured out whether to pay for it. The gauntlet cancer patients face with Provenge is being extended to everyone waiting for a medical breakthrough under Obamacare. Before a medical innovation can be used or paid for, the government will now demand additional research demonstrating that a new product will be more effective and cheaper than existing technologies. Since most new products come from small start-ups with limited cash, such a requirement means life-saving innovations will not be available at all.

This is why Heartland supports the Free to Choose Medicine project, which will allow for more drugs to be available, faster, and at lower cost. This model would deploy consumer choice and empower those who in consultation with their doctor decide to bypass the old FDA model.

Free to Choose Medicine would employ a dual track: on one track, a newly introduced drug goes through the lengthy clinical trials and testing necessary to achieve the FDA’s endorsement. But instead of that being the only option, an alternative would be created: on this track, patients could with their doctor’s counsel choose to contract with drug developers for access to the drug prior to approval.

The drug will need to have passed the midpoint of Phase II testing, so we’d already have knowledge to make an informed decision on the risk and effectiveness of it. The upshot: patients, many of whom are in desperate need of new treatments, could gain quicker access to new drugs by a pace measured in years, not months. For those facing life threatening illnesses and pain, this would eliminate the bureaucratic barriers to them receiving the treatment they want and need. No one should face death because bureaucracy moves too slowly. And in advancing the argument that government is a problem, not a solution, for medicine, Paul is entirely right.