Will the FDA Challenge State Right to Try Laws?

August 14, 2014

Two Americans suffering from Ebola have been given the experimental drug treatment ZMapp, which had previously only been tested on monkeys. The decision to provide the patients with a largely untested drug, writes Brittany La Couture of the American Action Forum, raises many questions about drug approval.

Generally, drugs that lack FDA approval cannot be used at all. For a patient with a terminal illness, his best chance at accessing an unapproved drug is to participate in a drug trial during phase II or III of FDA-required testing. Participation, however, can be difficult, as testing requirements limit participants based on age and stage of illness, as well as by their geographic location.

The FDA does operate a "compassionate use" program, which allows patients with serious or life-threatening illnesses to test unapproved drugs, provided that the applicant has no alternative treatments available to him.

  • The patient's doctor as well as the drug manufacturer must be on board with the experimental treatment.
  • Paperwork on the physician end can take up to 100 hours to complete, simply to submit one patient application.
  • The FDA then has 20 days to decide whether to grant a patient's request, which then must be approved by a panel of experts, known as the Institutional Review Board.

Because the compassionate use process is so cumbersome, states have recently begun passing "Right to Try" laws, granting terminal patients access to drugs that have passed phase I trials but have yet to receive FDA approval. The laws also protect doctors from misconduct charges for recommending the drugs. 

The FDA may begin to challenge state Right to Try laws. NCPA Senior Fellow John Graham has written about the possibility of an FDA challenge to these laws, specifically in the context of Colorado, which became the first state to pass such a law in May. According to Graham, "It would reflect a very perverse sense of justice for the U.S. government to act against a state law allowing desperately ill patients to try promising, experimental new medicines, while allowing Colorado's marijuana market to thrive unmolested."

Source: Brittany La Couture, "Right to Try," American Action Forum, August 11, 2014. 

 

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