CONCORD, N.H. (Jan. 6, 2016) – A bill introduced in the New Hampshire legislature would authorize heathcare facilities and physicians in the state to dispense medication, and use equipment and therapies not approved by the Food and Drug Administration, setting the foundation to nullify in practice some FDA regulations.

Rep. J.R. Hoell (R-Dunbarton), Rep. Glen Aldrich (R-Gilford) and Rep. Daniel Itse (R-Fremont) introduced House Bill 200 (HB200) on Jan. 4. The legislation would allow healthcare facilities and physicians licensed by the state of New Hampshire to dispense medication, and use equipment and therapies which are not approved by the FDA. If passed into law, the state would not be able to take any action against doctors or medical facilities who use unapproved therapies.

HB200 would not stop the FDA from taking action against a doctor or healthcare facility that utilizes unapproved treatments, but it would remove any threat of state sanction. Doctors would not have to worry about losing their license to practice in New Hampshire, and the state would not shut down a hospital or medical facility. In effect, passage of the bill would remove one layer of law preventing the use of treatments and drugs not approved by the FDA.

The proposed law expands on the idea behind Right to Try laws that have gone into effect in 33 states. Right to Try provides terminally ill patients access to medicines not yet given final approval for use by the FDA. The New Hampshire Right to Try law went into effect last summer. HB200 would open up the right to try to any patient in the state.

Federal law relating to the use of unapproved treatments remains murky. According to the Alliance for Natural Health, federal law clearly states that licensed physicians may “manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice” [21 USC 360(g)]. Furthermore, the Federal Food, Drug, and Cosmetic Act (FD&C) cannot regulate the therapeutic practices themselves. But as the ANH puts it, “While practitioners might have the theoretical right to manufacture their own drugs, from the practical point of view the FDA takes a very expansive view of its authority and jurisdiction.” In other words, the feds could conceivably file suit against a doctor or facility that uses unapproved treatments, but it’s not clear the FDA would win.

In practice, the FDA targets most of its enforcement efforts on the manufacturers of drugs and medical treatments, not physicians or facilities. In fact, doctors commonly prescribe FA approved medications for unapproved uses without any consequences. A study published in Archives of Internal Medicine in 2006 by Radley, Finkelstein, and Stafford found that 21 percent of sampled medications were being prescribed for off-label use.

The bottom line is it seems unlikely the FDA would aggressively come after doctors or healthcare facilities in New Hampshire for using unapproved medications or treatments, especially if they were demonstrably helping patients. Furthermore, federal agencies rarely have the resources to aggressively enforce their regulations without state cooperation. Passage of HB200 would remove such state assistance and leave the FDA on its own in New Hampshire.

In practice, the proposed law would open the door for any doctor or medical facility willing to take on the slight risk of FDA interference to try treatments not approved by the federal agency. This would allow doctors to use drugs tested and approved overseas in New Hampshire without an fear of state action. As more doctors take advantage of this option, it would potentially nullify in effect FDA control over drugs and medical treatments in the state.

Ultimately, patients would benefit from expanded treatment options. Many drugs available overseas have proven effective, but remain banned in the U.S. by the FDA. Passage of HB200 would potentially allow patients to access these treatments.


HB200 was referred to the House Committee on Health, Human Services and Elderly Affairs, It will need to receive a favorable report by the committee before moving on in the legislative process.

Mike Maharrey

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