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Colorado Makes an End Run Around the FDA

Kianna Karnes was a 41-year-old mother of four children diagnosed with kidney cancer in 2002. Her doctors prescribed interleukin-2, the only medication approved by the Food and Drug Administration (FDA) at the time to treat the disease, but it proved insufficient to stop the cancer’s spread. Kianna’s family petitioned the FDA to allow their mother to try an investigational new drug (IND) still stuck in the agency’s approval process. After all, she had nothing to lose. Despite gaining powerful allies including Congressman Dan Burton (R-Ind.) and the Wall Street Journal editorial board, it was too late. The FDA approved Kianna’s IND request the very same day she died.

Kianna’s story is just one of countless patients whose lives have remained in jeopardy because of the FDA’s dangerously inefficient drug approval process. Now some states are taking it upon themselves to make the necessary reforms. Last week, Colorado became the first [1] to sign a so-called “Right to Try” bill into law, empowering patients with the ability to petition pharmaceutical companies to provide them with INDs if they’ve exhausted all other options. While the push for Right to Try reform is compelling, its fate still remains uncertain due to the FDA’s reluctant history of allowing patients access to INDs.

While Kianna’s case was critical in drawing attention to the FDA’s bureaucratic approval process, it is by no means the first time the problem has gained national attention. In the 1980s, Milton Friedman wrote and spoke about the FDA’s perverse incentives in his book and television series, Free to Choose. Friedman explained [2] that it is much riskier for the FDA to approve a drug than disapprove it, since the agency can be publicly blamed if a bad drug goes to market, but nobody would know if a good drug is rejected. As a result, “we all know of people who have benefited from modern drugs,” yet “we don’t hear much about … the beneficial drugs that the FDA has prohibited.”

Granted, the approval process has marginally improved since the era of Free to Choose. In the late 1980s, the FDA introduced Expanded Access Programs (EAPs) in response to the AIDS crisis, allowing patients access to potentially life-saving INDs. However, the federal agency’s bloated bureaucracy has unsurprisingly crept into this compassionate use program. As Christina Corieri of the Goldwater Institute explains [3], “[F]rom 1987 until 2002, the FDA approved only 44 treatment IND applications for conditions ranging from AIDS to chronic pain – an average of less than three per year.”

While the FDA also grants individual IND applications for specific drugs, the approval process to do so is also backed up. Patients must appear before an institutional review board (IRB) at a regional medical facility. However, many IRBs only meet once a month and can be located hundreds of miles from a patient’s home. Consequently, countless lives may have been lost navigating the FDA’s bureaucracy.

Right to Try may soon allow America’s sickest to cut through the red tape. Originally drafted as model legislation by the libertarian Goldwater Institute, the bill has received bipartisan support, having been approved as a ballot measure in Arizona [4] and signed into law in Colorado [1]; it is currently awaiting Gov. Bobby Jindal’s signature in Louisiana [5]. Specifically, the model legislation would allow pharmaceutical companies to provide terminally ill patients with INDs that have passed at least Phase I of the FDA’s approval process, and prevents the state from bringing legal action against them.

It remains to be seen how the federal government will respond to Right to Try’s bold assertion of state prerogatives. After all, the legislation is intended to circumvent federal law. Most drafts are quite explicit in their disapproval of the FDA’s bureaucracy. Colorado’s text [6], for instance, sharply notes that “[p]atients who have a terminal illness do not have the luxury of waiting until an investigational drug, biological product, or device receives final approval from the United States food and drug administration.”

The FDA is well known for squelching even the slightest dissent to their approval process. In 2003, for instance, the Abigail Alliance and Washington Legal Foundation filed suit against the FDA [7], requesting that it make “regulatory changes to permit expanded availability of developmental lifesaving drugs following phase 1 clinical trials and at all subsequent stages of the trial and review process.” After a victory for patients’ rights in which the D.C. Court of Appeals ruled that terminally ill patients had a constitutional right to lifesaving drugs, the FDA appealed the decision in an en banc session before the whole circuit court. The judges overturned the decision and the Supreme Court refused to hear a further appeal, allowing the FDA’s stasis in allowing access to INDs to continue.

While the Right to Try’s fate is yet to be decided by the court of law, its defense will undoubtedly be bolstered in the court of public opinion. More than two-thirds of physicians agree that the FDA’s approval process is too slow and that doctors should be able to prescribe INDs, according to a poll by the Competitive Enterprise Institute [8]. This fact, coupled with the wide bipartisan support the Right to Try has received in several states, may persuade the Obama administration to turn a blind eye to the effort.

Fortunately, there is plenty of historical precedent for the federal government doing so. The administration refused to challenge Colorado and Washington’s legalization of marijuana for recreational use last year, for instance, despite the fact that cannabis remains a Schedule I drug [9], illegal at the federal level. Let’s hope for the sake of America’s sickest that common sense wins over rigid federal enforcement of a drug approval process that continues to put countless lives in danger.

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#1 Comment By Louis On May 30, 2014 @ 9:58 am

this is one of those no-brainers that frustrates every american.

Why a dying patient is denied access to drug trials and experimental drugs is unconscionable. If a person is near imminent death or diagnozed with a fatal disease and there are no other options then it should be part of their decision on how they wish to die. Some may choose euthanasia others may choose experimental drugs and still others no treatment at all.

The infuriating thing is how the US government has so much backbone when it comes to harmless cattle ranchers grazing rights or dying patients in need of care but they do have the backbone to resist public calls restricting pornography & gambling & usery, war and other exploitative vices

#2 Comment By RadicalCenter On May 30, 2014 @ 3:22 pm

It’s spelled “usury.”

So you want the government to respect people’s choices when it comes to medications and even killing themselves (or being killed by a doctor), but throw them in jail for gambling?

What conduct do you consider to be moral vice that you would NOT criminalize? Really curious.

#3 Comment By RadicalCenter On May 30, 2014 @ 3:25 pm

The libertarian-leaning folks in Congress — KY Senator Rand Paul, Michigan Rep. Justin Amash, Idaho Rep. Labrador — should be pushing federal legislation to curtail the power of the FDA and federal “law enforcement” where people diagnosed with a likely-terminal condition are concerned.

The statute should prohibit the federal government from interfering with state law on this issue. (The Tenth Amendment already does that, but we all know that Amendment is even more ignored than most of the others.)

#4 Comment By Rachel On June 1, 2014 @ 2:03 pm

Does the Right to Try law limit liability if a patient tries a drug that hasn’t been thoroughly vetted and suffers a bad side effect as a result?

#5 Comment By Beyondxx On June 1, 2014 @ 3:57 pm

In the late 1980s, the FDA introduced Expanded Access Programs (EAPs) in response to the AIDS crisis

What, not even a shout-out to the protestors that forced the FDA’s hand?

#6 Comment By Okie Exile On June 2, 2014 @ 11:56 am

I am in general agreement with giving patients in severe situations access to INDs. That said, is there a potential issue with making it too easy for drug companies to profit from selling INDs, and with no legal liability from any side effects or complications? That could give companies an incentive to keep drugs at that approval phase, as they can still profit from demand but are immune from potential lawsuits.