Is FDA Labeling Sending
Patients Across the Borders?

BY JAMES V. AQUAVELLA, M.D.
MAY 1996

Since the Food and Drug Administration approved photorefractive keratectomy late last year, the media blitz for refractive surgery in many communities has been astounding.

Now, an unexpected aspect has emerged, particularly in those states bordering Canada or Mexico. Well-funded foreign excimer laser groups have launched a campaign whose message is that refractive surgeons in the United States are prohibited by the FDA from using first generation excimer lasers to correct moderate and high levels of myopia and astigmatism. These advertisements imply that only the modern, "state-of-the-art" technology that's available outside the United States can solve all refractive problems, and consequently, patients would be well-advised to travel across the border for refractive surgery.

DECIPHERING THE REGULATORY CRYPTOGRAM

Discussing the various alternatives of myopia correction and refractive surgery with patients is time-consuming. Add to this the time required to answer questions about FDA labeling and second generation lasers, and it's apparent the average eyecare practitioner is faced with a significant problem, particularly when trying to decipher and explain the legal, regulatory and ethical issues involved.

The whole concept of FDA labeling for drugs and devices has not changed in recent years. Basically, the FDA requires that the label on a drug or device be consistent with all claims and advertising by manufacturers or physicians. Thus, if the FDA approves a particular drug to treat arthritis, neither physicians nor the manufacturer can advertise that the drug can be used for other conditions (for example, as a muscle relaxant). To openly state that the drug can be used for this condition, without a formal application to the FDA for marketing clearance, constitutes a violation of the labeling provision.

ACTING IN THE PATIENT'S BEST INTEREST

When advocating a particular treatment, device or medication for a specific patient, however, the physician has always had the prerogative, if not the obligation, to use not only the information provided by the FDA-approved label, but also other available literature.

Thus, the specifics of a patient's condition, as well as current medical knowledge as evidenced by publications, research and accepted procedure, are considered when developing a treatment plan. Physicians are not prohibited from using a particular device or medication in ways that are not specified on the FDA-approved label, provided that their actions are in the best interests of the patient and are directed toward a specific patient.

INTERPRETING THE
STATUS QUO

New uses of drugs and devices are developed almost daily, but it's unusual for a manufacturer to request label modifications by the FDA given the cost and complexity of the process.

While this situation may seem confusing to many patients and practitioners, there is clearly no strong interest on the part of manufacturers, physicians or the FDA to alter the status quo. As long as manufacturers and physicians don't make broad advertising claims that are not substantiated by the FDA-approved label, it's unlikely that medically appropriate usage will be actively pursued by the regulatory agencies.

In the final analysis, physicians in the United States should be able to use their lasers to treat patients as they see fit, provided the treatments are medically sound. Tell your patients not to purchase tickets to Canada or Mexico unless they're going on vacation. CLS

Dr. Aquavella is chairman of the Genessee Valley Eye Institute and director of the corneal research lab at the University of Rochester.