A Big Win in the U.S. Supreme Court

There were three sharp cracks of the gavel, and everyone stood at attention.

“The Honorable Chief Justice and the Associate Justices of the Supreme Court of the United States. Oyez! Oyez! Oyez! All persons having business before the Honorable Supreme Court of the United States are admonished to draw near and give their attention, for the Court is now sitting. God save the United States and this Honorable Court!”

A Proceeding Steeped in Tradition

The burgundy-draped, gold-trimmed room had all the aspects of a church. There was a distinctive air of solemnity as we awaited the Justices, and people talked in respectful, reverent whispers. Clerks quietly scurried around, placing stacks of papers and silver goblets of water at each Justice’s chair.

After the traditional announcement that the court was in session (oyez, pronounced “oh yay,” is a Middle English word meaning hear ye), in marched nine of the most powerful people in the world: Chief Justice William Rehnquist and Justices John Paul Stevens, Sandra Day O’Connor, Antonin Scalia, Anthony Kennedy, David Souter, Clarence Thomas, Ruth Bader Ginsberg, and Stephen Breyer.

Clad in black robes, the Justices performed the time-honored “conference handshake,” a symbolic reminder that despite their differences of opinion, their shared goal is justice. They then sat down at an elevated table, Chief Justice Rehnquist in the middle and the others seated around him by seniority, and got down to business, making decisions that will affect every American, and to some extent, the entire free world.

The Privilege of a Lifetime

I have been to Washington, DC, numerous times. I’ve visited Capitol Hill and lobbied congressmen and senators on issues regarding medical freedom. I’ve held press conferences at the steps of the Supreme Court and in the “Senate Swamp” adjacent to the Capitol Building. I’ve even attended functions where the President was present. However, none of these affected me quite as much as walking into the chambers of the Supreme Court.

It dawned on me that very few people have seen the workings of the Supreme Court. Unlike other branches of our government, this court does not function in the public eye. Every day, hundreds and hundreds of people get in line and tour the White House and the Capitol Building. You can go inside the Supreme Court, and if your timing is right and the Court is in session, sit in the audience and observe some of the proceedings. However, the number of people who have done this is actually very small.

But to have a second-row seat for an entire hearing in the regal Supreme Court chambers, listening to lawyers presenting oral arguments and our highest Justices asking them questions, as my wife Connie and I did on February 26, 2002, was a rare privilege indeed.

Why I Was There

I was there to hear arguments regarding compounding pharmacists, who are currently under legal threat by the government.

Compounding harks back to the days of old when pharmacists actually measured and mixed ingredients together. Although this practice has largely been replaced by manufactured pills and capsules, which pharmacists simply count out, there remains a need for individualized prescriptions.

A child, for example, might require a smaller dose or different delivery system of a specific drug. Or a physician might prescribe an item that, because of patent and profitability issues, simply isn’t available. (Virtually all of the hormones we use at the Whitaker Wellness Institute such as estrogen and progesterone are compounded with natural ingredients that are simply not available in off-the-shelf prescription items.)

The FDA Prohibited Freedom of Speech
For several years, the Food and Drug Administration (FDA) has attempted to prevent compounding pharmacists from promoting or advertising their goods and services, even to doctors. In short, this bureaucracy is trying to shut the industry down by cutting off its lines of communication with its customers.

In 1998 a federal district court ruled that this violated the pharmacists’ right to free speech, as guaranteed by the First Amendment to the Constitution. Despite the fact that this was a classic freedom of speech issue, a series of appeals questioned the verdict, and ultimately the case landed in the Supreme Court.

Many physicians, myself included, depend on compounding pharmacies, and legions of patients across the country would suffer if denied access to compounded drugs. Equally important, advertising is a protected form of communication and serves a vital purpose in society by letting people know what is available. The FDA has no business restricting advertising or any mode of speech, and in this case such a restriction would interfere with medical freedom of choice.

Therefore, I and a few other concerned individuals and organizations commissioned Washington attorney Jonathan Emord, who has successfully battled the FDA on constitutional grounds, to submit an amicus curiae (literally, “friend of the court”) brief. I wasn’t a party to the suit, but the brief became part of the case, and in fact, Justice Ginsburg used information from the brief to pose a question to the government (FDA) attorney.

The Process in Action

The case began, following the same pattern as all oral arguments before the Supreme Court. Each lawyer gets 30 minutes to present his or her case. They start talking in incomprehensible legalese, explaining the points of their argument, only to be immediately interrupted by the Justices with simple, direct, perfectly germane questions.

Edwin S. Kneedler, the attorney for the government, went first. His argument was that restriction of advertising would serve the public good by limiting the size and availability of compounding pharmacies, which make drugs that don’t have to undergo the FDA-mandated drug approval process. Furthermore, these pharmacies threaten the pharmaceutical industry.

An Argument on Constitutional Grounds
Howard M. Hoffman, attorney for the pharmacists, asserted that the ban on advertising is clear and unadulterated censorship of free speech, guaranteed by the First Amendment of the Constitution.
Several Justices came down hard on advertising restrictions, countering that they were problematic under the First Amendment. Referring to the previous court’s decision in favor of the pharmacists, Justice O’Connor stated, “…the court below seemed to think that was not necessary, and I think I have the same problem.”

Justice Breyer gave as an example a child with cancer who could not swallow adult-sized pills and would therefore benefit from the pills being compounded to a smaller size. If the government bans advertising (communication) of pharmacists who provide these services, Justice Breyer inquired, how would a doctor know that he could use a compounding service to help his patient? The government lawyer inanely replied, “He would have to ask.” With that, Justice Breyer simply pushed his chair away from the table.

An Impressive Show of Judicial Acumen

Throughout the proceedings I was struck by how knowledgeable the Justices were and how their questions and comments tended to simplify, not cloud the issues.

As the hearing concluded and we walked down the marble steps of the courthouse, I pondered the impact that the process I had just witnessed has made upon our country and indeed our world: Brown v. Board of Education desegregated our schools.Roe v. Wade legalized abortion. Miranda v. Arizona changed the manner in which police question suspects.

And to think that each of these decisions, which have dramatically affected our lives, followed exactly the same procedure I had just observed.

Postscript: Victory!
The U.S. Supreme Court found that the restrictions on compounding pharmacies were more extensive than necessary to achieve the government’s purported interests (protecting the public and preserving the integrity of the drug approval process). The Court stated that there were less restrictive alternatives, including the use of disclaimers on compounded drugs explaining that the compounded drugs had not been subject to FDA approval or a full safety review.

The case established commercial speech rights for compounding pharmacists under the First Amendment.

Modified from Health & Healing, April 2002, with permission from Phillips Health, LLC. © copyright 2002, Phillips Publishing, Inc. Photocopying, reproduction, or quotation strictly prohibited without written permission from the publisher. To subscribe to Health & Healing, call (800) 539-8219.