When physicians go beyond the directions given in a drug's package insert, it does not mean they are acting illegally or unethically.
Four years ago, he saw a patient who had been treated by another physician with HA fillers for this very problem. The patient had presented with bluish superficial papules of the lower eyelid skin occurring after HA injection.
Dr. Filler diagnosed the problem as technique-related, but he assured the patient that a series of hyaluronidase injections would solve the problem. Although hyaluronidase, approved by the Food and Drug Administration (FDA), was available commercially, Dr. Filler purchased his hyaluronidase, at markedly decreased fees, from a local compounding pharmacy.
The unhappy patient sued Dr. Filler, but not her original physician. Dr. Filler was sued because of the infection-induced scar and because he used compounded hyaluronidase for an off-label purpose.
Dr. Filler contacted his malpractice carrier and was astonished to find that his carrier would cover him for the infection claim, but not for the compounded pharmacy off-label claim. The carrier contended that a physician using compounded pharmacy materials for off-label purposes was not covered under standard malpractice policies.
During the following two years, Dr. Filler was forced to pay his own attorney almost $100,000 to defend his case. Ultimately, Dr. Filler won the case, and now he seeks to sue his malpractice carrier for not providing coverage on the second claim.
Off-label, and on
When the FDA "approves" a drug, it is approving the labeling for that medication. The label must include information about the product, indications for use in specific populations, method of administration, dosage, contraindications, and any known risks or precautions that should be taken.
After the label and specific indication is approved, the FDA continues to monitor the promotional activities of the pharmaceutical manufacturer through its Division for Drug Marketing, Advertisement and Communication agency.
However, the FDA has a minimal role in regulating the physician clinical use of the drug after this point.
The FDA does not require approval for all clinical purposes for which the drug may be used, only those intended uses for which the manufacturer sought and received FDA approval. Once a drug has been approved for a specific indication, physicians may, using their discretion, prescribe the drug for any use that they deem medically safe and appropriate.
When a drug is prescribed for an indication, population, dose or method of administration that is not specifically included on the label, it is considered an off-label use. Physicians are permitted to prescribe off-label uses because neither the FDA nor the federal government regulates the practice of medicine.
In fact, new uses for drugs are often discovered, reported in medical journals and at medical meetings, and subsequently may be widely used by the medical profession. When physicians go beyond the directions given in the package insert it does not mean they are acting illegally or unethically, and Congress never intended to empower the FDA to interfere with medical practice by limiting the ability of physicians to prescribe according to their best judgment.
This practice of off-label use is not only common, it is an accepted and necessary corollary of the FDA's mission to regulate in this area - without directly interfering with the practice of medicine.
A 2003 report on off-label use found that for the three leading drugs in each of the 15 leading drug classes, approximately 21 percent of prescriptions were for off-label use.
Another recent study found that one in five prescriptions written in the United States - as many as 173 million each year - is for unapproved use. In fact, as many as one in seven drug prescriptions are written for reasons that have little or no scientific support.
The practice of off-label use is so widely accepted that even Medicare, Medicaid and private insurers are required to provide reimbursement for certain off-label uses. Furthermore, no law in any state specifically requires a doctor to inform his or her patient that a drug is being prescribed for off-label use.
Dr. Filler was practicing quality medicine when he used hyaluronidase for off-label purposes. But what about the purchase of this material from a compounding pharmacy?
Dr. Filler's malpractice carrier would be on strong ground if hyaluronidase was not FDA-approved for any purpose, but it is. The issue has arisen solely because he purchased compounded pharmacy materials.
In 2002, the Supreme Court looking at the case of Thompson v. Western States Medical Center agreed with a regulatory provision that permitted compounded drugs to be sold, although they had not passed the FDA approval process, on the condition that those compounds were not advertised.
The court held that although the FDA and the government had a substantial interest in protecting public health and preserving the integrity of the FDA approval process, an FDA ban on the use of compounded drugs was not necessary. As a result, Dr. Filler may be able to win his lawsuit against his malpractice carrier.
David Goldberg, M.D., J.D., is director of Skin Laser & Surgery Specialists of New York and New Jersey; director of laser research, Mount Sinai School of Medicine; and adjunct professor of law, Fordham Law School.