Experimental Medications: “Right-to-Try” Legislation is Rejected—Is that Good or Bad?

Laws, Medication Errors

Presently all medications administered to patients by a physician or healthcare staff member with the authority to order such medications must be approved by the Food and Drug Administration (FDA).  More specifically, the use that was approved by the FDA must match what the FDA approved the medication for, i.e. no off-label usage.  

New legislation was proposed to allow seriously ill patients to bypass the Food and Drug Administration (FDA) to use experimental treatments.  This was coined as a “last resort” type of legislation.  The idea was to permit patients who “have nothing to lose” to try experimental medications.

However, in recent action the House of Representatives rejected the bill.  Lawmakers did not like how it circumnavigated the protections and power of the FDA.  Whereas some proponents thought it loosed the restrictions and gave access to patients while still having patient protections.

Approximately 75 patient groups, including the American Cancer Society Cancer Action Network, the American Lung Association, and the Cystic Fibrosis Association, all sent letters to House leaders saying that bill would not help because the issue if not barriers to experimental drugs, but actually the cost of the drugs and company restrictions.

But what about a medical malpractice standpoint?  On one end, a doctor prescribing medication that he or she does not know much about—especially because there are no clinical trials or limited research—could mean the doctor is committing medical malpractice.  As the standard is one of a reasonably prudent healthcare provider, and such provider would surely not give unknown medications to a patient—right?

But on the other hand, a patient is terminally ill.  The patient has no other options.  If the patient was going to die anyway, and the medication causes the patient’s death, what harm was there?  What is a patient has a 99% chance that to die, and this experimental drug lowers that chance to 80%?  Should the doctor still do it if not approved?  That 20% seems like a big gap, and one would easily say yes.  But what if that difference was 99% chance to die, or with this new experimental medication a 98% chance to die—should a doctor still do it?  

These are not just medical and legal questions, but ethical ones.  In a medical malpractice field, a healthcare provider would likely have released and acknowledgements of the experimental medication and warning that there is a serious chance of death in a non-approved medication.  These are very serious considerations, and likely a healthcare provider would be insulated.

But what do you think?  I would love to hear from you!  Leave a comment or I also welcome your phone call on my toll-free cell at 1-866-889-6882 or you can drop me an e-mail at jfisher@fishermalpracticelaw.com.  You are always welcome to request my FREE book, The Seven Deadly Mistakes of Malpractice Victims, at the home page of my website at www.protectingpatientrights.com.