Yes, with an explanation. Of
course, if your doctor is prescribing a medicine, it must be approved by the
Food and Drug Administration (FDA). But, it may not be approved for your
specific condition. Let me explain.
The FDA is charged with determining when a drug is
considered safe and effective and can be brought to the marketplace. Bringing a drug from the research bench to
the pharmacy is a complex and arduous process that takes many years, even when
it’s running smoothly and on schedule.
As you might expect, there are often unforeseen obstacles that will
extend the timeline to approval when the FDA requires more studies to address their concerns. Often, the drug must be
abandoned at some point in the process, after millions of dollars of R & D
investment. We should consider this
reality before we demonize PhRMA reflexively, which has become sport today.
Guardians of Safety
When a drug is ultimately approved, this approval is only
for a specific medical indication. For
example, a new antibiotic may be approved to treat a urinary tract infection
(UTI). Physicians, however, are free to prescribe any medicine for any
reason. For example, a physician may
prescribe the ‘UTI medicine’ to treat a pneumonia, if the physician believes
this would be an effective option.
Does the FDA object to this ‘off-label’ use? Not at all.
They recognize that off-label use is often appropriate and standard care
that is supported by medical evidence.
Patients should recognize that most prescriptions that we physicians
write are for off label use. Moreover,
if you ask your doctor the next time you are in the office what are the
official FDA approved uses of your medications, I think that he will stumble in
his response. Why? Because most of us don’t know the official
FDA indications of many of your medicines.
I know this makes us sound sloppy and incompetent, but we’re more
focused on choosing the right medicine than on whether it’s ‘approved’. Similarly, patients should be more concerned
if the choice of a drug is rationale than if the FDA has approved it for your
particular condition. Moreover, some
illnesses have no FDA approved drugs for them, yet there are effective
medicines available, which we physicians will prescribe.
Find out if your medicines are off-label or approved. You might be surprised. Remember, off-label may be on-the mark.
Well said!
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