Defending Use of Unapproved Drugs

* The UCI fertility clinic may well be accused of a lot of things, but I do not believe that solely using a drug not yet approved by the FDA should be considered a wrongdoing. Like all other fields in medicine, a physician is often forced to make a decision for the patient’s benefits. If the patient’s decision is arrived at after having been fully informed of an unapproved drug’s risks and benefits, should a FDA stamp be the sole stumbling block on her path to bearing a child?

There are many reasons other than efficacy and safety that get a drug held up at the FDA. However, there is little for the FDA bureaucracy to gain in hastening a drug’s approval and much to lose should a drug turn out to be causing serious side effects. The result is usually inertia and often a drug is held up in its approval process for years by nothing more than a single word in the package insert. On the other hand, it is often difficult for someone with a scientific mind and compassion to deny a patient access to what in the physician’s studied opinion is otherwise a far superior and acceptably safe drug.

JOHN T. CHIU, M.D.

Corona del Mar