Discuss whether the fda has the authority to regulate

Reference no: EM133638285

Case: Discuss whether the FDA has the authority to regulate drugs intended for lethal injection, or other devices used for execution (such as electric chairs, gallows, firing squads, and firearms), as "drugs" or "devices" under the FDCA. How would the FDA Tobacco case apply to this question?

Factors to consider:

Definitions of "drug" and "device" in the FDCA
FDA's "efficacy" and "no harm" requirements
Whether FDA would have to ban execution drugs and devices

In thinking about how the FDA Tobacco case would apply to this question, consider the following:

If a product can't be safely used for a therapeutic purpose but also can't be banned, does it fit under the FDCA's regulatory scheme?
Is it relevant that the FDA claimed it did not have the authority to regulate drugs/devices used in capital punishment before 2017?
Does it matter whether a particular substance is safer or more effective than other means of execution?
In the tobacco case, the Supreme Court reasoned that Congress had repeatedly confirmed that tobacco products would remain available. How would that reasoning apply in the context of capital punishment and availability of the death penalty?

If the FDA doesn't have jurisdiction regulate lethal injection drugs, what are the implications for importing drugs from other countries for this purpose? Are there any safety concerns?

Reference no: EM133638285

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