Posted: 13 Jul 2015 07:09 PM PDT
By James C. Shehan –
On July 9, 2015, Representatives Matt Salmon (R- AZ), Paul Gosar (R-AZ) and Marlin Stutzman (R-IN) introduced H.R. 3012, the Right to Try Act of 2015. The bill seeks to expand the access of terminally ill patients to experimental drugs in a novel way, by prohibiting the federal government, including FDA and DEA, from taking action to stop such access.
The bill is short and straightforward. It simply states that, notwithstanding any law, including the Federal food, Drug, and Cosmetic Act, the federal government shall not take “any action to prohibit or restrict the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that - (1) is intended to treat a patient who has been diagnosed with a terminal illness; and (2) is authorized by, and in accordance with, State law. An “experimental product” is defined as one that “has successfully completed a phase 1 clinical investigation,” remains under investigation in an FDA-approved clinical trial, and is not FDA “approved, licensed, or cleared.” The term “terminal illness’’ is defined as the meaning given to such term under relevant State law.
The legislation is viewed by at least one of its sponsors, Rep. Stutzman, as complementary to state right to try laws. These laws (see our previous post here) also allow doctors, patients and companies to bypass FDA’s regulations. But given the reluctance of companies to violate regulations that require prior FDA approval of expanded access, these laws are not being regularly used.
Whether this bill if passed would change this situation is unclear. On the one hand, it bars FDA from doing something that it almost never does – denying access to an experimental drug to a terminally ill patient. On the other hand, by preventing FDA from taking any action to stop access, it potentially undermines FDA’s entire expanded access regulatory regime. Although the bill does not mention the companies that make experimental products, the bill could be interpreted as prohibiting FDA from taking enforcement action against anyone who ignored the expanded access regulations, including the companies. Whether FDA would agree with that interpretation and whether companies would decide to not seek FDA approval in the face of such ambiguity remains to be seen.
On July 9, 2015, Representatives Matt Salmon (R- AZ), Paul Gosar (R-AZ) and Marlin Stutzman (R-IN) introduced H.R. 3012, the Right to Try Act of 2015. The bill seeks to expand the access of terminally ill patients to experimental drugs in a novel way, by prohibiting the federal government, including FDA and DEA, from taking action to stop such access.
The bill is short and straightforward. It simply states that, notwithstanding any law, including the Federal food, Drug, and Cosmetic Act, the federal government shall not take “any action to prohibit or restrict the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that - (1) is intended to treat a patient who has been diagnosed with a terminal illness; and (2) is authorized by, and in accordance with, State law. An “experimental product” is defined as one that “has successfully completed a phase 1 clinical investigation,” remains under investigation in an FDA-approved clinical trial, and is not FDA “approved, licensed, or cleared.” The term “terminal illness’’ is defined as the meaning given to such term under relevant State law.
The legislation is viewed by at least one of its sponsors, Rep. Stutzman, as complementary to state right to try laws. These laws (see our previous post here) also allow doctors, patients and companies to bypass FDA’s regulations. But given the reluctance of companies to violate regulations that require prior FDA approval of expanded access, these laws are not being regularly used.
Whether this bill if passed would change this situation is unclear. On the one hand, it bars FDA from doing something that it almost never does – denying access to an experimental drug to a terminally ill patient. On the other hand, by preventing FDA from taking any action to stop access, it potentially undermines FDA’s entire expanded access regulatory regime. Although the bill does not mention the companies that make experimental products, the bill could be interpreted as prohibiting FDA from taking enforcement action against anyone who ignored the expanded access regulations, including the companies. Whether FDA would agree with that interpretation and whether companies would decide to not seek FDA approval in the face of such ambiguity remains to be seen.
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