Subject Matter Expert Insights
Some issues that are encountered frequently:
Is a generic drug identical to the innovator drug?
It is not necessarily identical to the innovator. In many cases one or more of the inactive components – called excipients – are different. This is usually done because they are cheaper than those in the innovator product.
When is a dietary supplement a drug and not a dietary supplement?
The Food Drug and Cosmetic Act defines a drug as “…articles (other than food) intended to affect the structure or any function of the body of man or other animals….”
When a dietary supplement falls within the FDA’s definition of a drug it is considered to be a drug. That is an unapproved drug since it entered the market being called a dietary supplement and therefore did not have the FDA review clinical data and other aspects of the product.
When can a drug be used off-label?
A physician can prescribe the off-label use of a pharmaceutical product. A company or its representatives cannot suggest, recommend, or in any way advocate the off-label use of its drugs.
Recently some companies have paid fines for having their representatives suggest to physicians that their drugs can be used off-label. The motivation for doing this is generally believed to be, pure and simple, money, with no concern for the patient
Is fault always with one person or company, or can fault be shared?
In many cases where there is a chain of possession, ownership, and responsibility, more than one party is at fault. Each case is an individual one and the review of the appropriate documents will either determine, or provide direction to determine, who is at fault.
Can sterility of an injectable drug be guaranteed at the patient level after traveling through so many hands?
Sterility should be maintained at the patient level. In any case where such a drug is not sterile and is injected into a patient, serious problems, and in some cases death, can occur. This answer is similar to the one above regarding fault. There is a chain of ownership from the drug company to the patient. Each case is an individual one and the review of the appropriate documents will either determine, or provide direction to determine, who “broke sterility.”
What does the label say can and cannot be done with this drug?
The directions are on the label and are also given to the patient by the physician. It is important for the physician to know all other medications and any dietary supplements that the patient is taking at the time. This is because some drugs should not be taken while also taking certain other drugs.
A fundamental principle in life is KEEP YOUR WORD!
If everyone along the line from producer to patient kept his/her word, there would be no problems. However, the path from producer to patient is often a long one, and sometimes some persons in the chain don’t live up to their contractual obligations and therefore don’t keep their word. The results can be catastrophic. Patients can be hurt or killed. One of the jobs for the attorney and the Subject Matter Expert is finding which parties did and did not keep their word. The evidence tells the story and that evidence is in the documentation.
My experience has shown that the most important documents in a case are those that the opposition has “difficulty finding.”