The Abigail Alliance Case: Moving The Discussion On Access To Developmental Drugs Forward

Monday, October 1, 2007 - 01:00

Editor: Mr. Wood, would you tell our readers something about your professional experience?

Wood: I am a partner in the litigation department at Kelley Drye & Warren. I have been at the firm since 1992 and a partner since 2001. Early in my career, I was engaged in a great deal of toxic tort litigation, mostly involving asbestos. With the passage of time I moved into handling products liability cases, primarily for pharmaceutical and medical device companies. This evolved further into complex litigation, including class actions and multijurisdictional proceedings across a wide array of courts.

Editor: You have been following the progress of Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach for some time. For starters, would you give us the background of this case?

Wood: Yes. I have been following this case because of its potential impact on the pharmaceutical industry and because of the compelling issues in the case, both legal and philosophical. Abigail Burroughs was a young woman who developed cancer and, not too long after her diagnosis, died in 2001. Following her death her father established an organization, the Abigail Alliance For Better Access To Developmental Drugs, to help persons like his daughter gain access to drugs in the developmental stage, but not yet approved for commercial use by the Food and Drug Administration. Again, by way of background, following Abigail's diagnosis, her oncologist had determined that her cancer might respond to one of two drugs - Erbitux and Iressa - that were in development at the time. Unfortunately, despite the heroic efforts of the Burroughs family, she was not able to obtain access to these drugs prior to her death. The Abigail Alliance is one of two plaintiffs in the case.

Editor: And the plaintiffs' position on access to experimental medications prior to FDA approval is to force some kind of acceleration of the approval process?

Wood: Essentially that is correct. I might modify that by saying "accelerate access." With any person who has been diagnosed with cancer there is almost always a race against time. Timely access to treatment can make the difference between life and death.

The regulatory structure that governs the approval of new drugs has been in place since the 1960s. It does provide for limited access to developmental drugs for people with life-threatening conditions and no other treatment options. The FDA has argued that the present structure represents the best balance of all of the interests and should not be dramatically altered.

Again, by way of background, in January of 2003 the Abigail Alliance submitted a regulatory proposal to the FDA intended to make investigational drugs available for purchase at the earliest stages of human testing. The FDA responded by stating that such regulations would upset the balance that it, the agency, considered appropriate. The Alliance served a Citizen Petition on the FDA, to which the agency did not formally respond. That set the stage for the Alliance's law suit.

Editor: What occurred at the trial court level?

Wood: The action was filed in 2005 in the U.S. District Court for the District of Columbia by the Alliance and the Washington Legal Foundation. The matter was decided on a motion to dismiss brought by the FDA. Essentially, the trial court concluded that the plaintiffs were not seeking to advance a fundamental constitutional right. In addition, the court determined that the actions of Congress and the FDA had been rational. The FDA's motion to dismiss was granted. The plaintiffs then appealed.

Editor: Please take us through the two decisions of the U.S. Court of Appeals for the District of Columbia.

Wood: The appeal was initially decided in May of 2006 by a panel of three judges of the Court of Appeals for the DC Circuit. That panel ruled two to one in favor of the plaintiffs. The court essentially held that once the FDA had determined, after Phase One trials, that a potentially life-saving investigational drug was sufficiently safe for human use, terminally ill patients have a constitutional right to seek treatment with the drug if there are no other FDA-approved drugs available. The ruling of the court was grounded in the Fifth Amendment's guarantee of due process, including a right on the part of persons facing terminal illness to make fundamental decisions regarding medical treatment. The court went on to indicate that if the FDA wished to deny patients access to drugs that had completed their Phase One trials, it, the FDA, had the burden of demonstrating that its restrictions were narrowly tailored to serve a compelling governmental interest.

The FDA's response to the decision of the three-judge panel was to make an application for rehearing by the DC Circuit sitting en banc , which was granted. The case was then argued before the entire court. On August 7th of this year a decision was issued reversing the panel's decision and holding that there is no fundamental right to access to investigational drugs grounded in the Constitution. The en banc decision was eight to two, with the two dissenting judges being the majority in the three-judge panel decision.

One of the difficulties, I think, lies in the approach taken by the Alliance in attempting to characterize its objective as a fundamental constitutional right. The Alliance chose a regulatory approach initially, and, as I understand it, chose litigation when regulatory efforts stalled. Courts decide disputes by application of legal principles to facts. In analyzing the issues in this case, the en banc court distinguished cases, relied upon by the Alliance, where the United States Supreme Court had determined that the authorities could not interfere with an individual's right to reject life-saving medical treatment. In addition, the majority did not see the case before them as characterizing a right to life, self-defense or self-preservation, but rather as a right to access to developmental drugs, as to which it found no fundamental constitutional right.

Editor: This is a pretty decisive determination by the DC Circuit. Is the U.S. Supreme Court likely to accept an appeal?

Wood: I agree, eight to two is pretty decisive. I believe, nevertheless, that the Alliance intends to file a petition for certiorari with the Supreme Court. One of the challenges this case presents to any court is that the emotions run extremely deep, and matters of life and death affecting the youngest in our society demand action. The Alliance also makes some strong policy arguments, but the policy arguments, I believe, may not fit well into the analytical framework applied by the courts in individual rights litigation. In any event, if I were a betting man I would place my bet on the likelihood that the Supreme Court will not grant cert.

Editor: If the Supreme Court does not take the appeal, what are the implications? Is there any set of facts that - narrowly presented - might enable a terminally ill patient to access experimental and unproven drugs?

Wood: That is a good question, and it brings us back to the policy issues underlying this dispute. The fact is that currently, even under the present regulatory scheme, there are procedures under which terminally ill patients can gain limited access to developmental drugs. One involves participation in clinical trials. One of the problems with that option, however, is that when an individual enrolls in a clinical trial, treatment is usually randomized. That is, the patient may or may not receive the drug that is being investigated. Another problem with this option is that many terminally ill patients are precluded from participation in trials because they do not meet the criteria. Clinical trials have very specific eligibility criteria. If, for example, the patient has been through just one round of chemotherapy, that is probably sufficient to disqualify her from participation. A second way in which a patient may obtain access to investigational drugs before approval is through what is called a "compassionate use" exception. This process is initiated by a physician's application, which is then reviewed by a local institutional review board. If the compassionate use application is approved, it is submitted to the drug company, which must agree to provide the drug. The problem here, of course, is the time it takes to go through the process. Cancer patients usually do not have the luxury of time. Another option is the treatment IND process, which, subject to FDA approval gives a patient access to drugs that are in Phase Three trials. Again, the process consumes precious time.

I should point out that in December of 2006 the FDA proposed a new rule, for comment, that would amend its regulations to permit treatment use for individual patients, including emergencies, intermediate-size patient populations and larger populations under a treatment investigational new drug protocol.

One of the overarching questions here is whether the courts are the best forum for deciding these issues. In my view, these issues would probably be better addressed in a regulatory or legislative forum. In 2005, for example, Senator Brownback, Republican of Kansas, proposed a bill - it did not become law - entitled the "Access Compassion Care and Ethics for Seriously Ill Patients Act," which would have provided accelerated access to investigational drugs for terminally ill persons with no other treatment options. If the Supreme Court were to recognize a constitutional right to access to developmental drugs this might expose pharmaceutical companies to liability. That is, a terminally ill patient claiming such a constitutional right might bring an action against a company to compel it to provide the drug. That may seem an unlikely scenario, but it's certainly possible. In addition, companies could be sued for providing a drug which led to an arguably adverse outcome. The statute proposed by Senator Brownback attempted to meet this concern by providing for the patient's execution of an informed consent and a waiver of the right to sue the supplier of the investigational drug. As I say, it is in the legislative or regulatory arena that these issues might be best addressed rather than in the courtroom.

Editor : Is there anything you would like to add?

Wood: One thing we shouldn't overlook is that any mechanism for early access will only be as successful as there are drugs available to give to patients. This is an issue that perhaps the Abigail Alliance has not focused on. It's one thing to have a constitutional right of access, but without a willing supplier, what do you have? The Alliance has focused public attention on some very important issues, though. Families whose loved ones are fighting a terminal illness are desperate in trying to seek some sort of treatment before it is too late, and they are frustrated by what must appear to them to be the inertia of a seemingly indifferent bureaucracy. They simply do not understand why the agency is, at least in their eyes, digging in its heels on this matter. Clearly, however, the FDA is concerned, and must be concerned, about the impact that Phase One access might have on drug companies, the approval of new drugs, and patient safety. I am hopeful that this dispute will be resolved in a way that, if not completely satisfactory to the patients, will at least result in more efficient and quicker access to developmental drugs than is presently the case. I think that any such resolution is probably going to be achieved in the legislative and regulatory arena, not in the courts.

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