TITLE 21 - FOOD AND DRUGS
21 U.S. Code § 355 - New drugs
(…)
(i) Exemptions of drugs for research; discretionary and mandatory conditions; direct reports to Secretary
(…)
(4) Regulations under paragraph (1) shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible, it is contrary to the best interests of such human beings,….
(…)
[ EMPHASIS: “…informed consent…except where it is not feasible, it is contrary to the best interests of such human beings,…” ]
{ ===> They decided informed consent is not in your best interest. }
Interesting.
However, that section refers to the administration of an approved drug being given to someone "in their best interests." Think of it as giving a mental health drug to a homeless person who is arrested and brought to a mental institution.
The more relevant section of US Code is 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies:
- (e) Conditions of authorization
- (1) Unapproved product
- (A) Required conditions
- With respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:
- (i)Appropriate conditions designed to ensure that health care professionals administering the product are informed—
- (I) that the Secretary has authorized the emergency use of the product;
- (II) of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and
- (III) of the alternatives to the product that are available, and of their benefits and risks.
- (ii)Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—
- (I) that the Secretary has authorized the emergency use of the product;
- (II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
- (III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
- (iii) Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the product.
- (iv)cFor manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records access by the Secretary, with respect to the emergency use of the product.
Note that this section is for Emergency Use Authorization and includes informed consent and the option to refuse.
I underlined the part about "consequences, if any, of refusing administration of the product" because I believe this pertains to the medical "consequences" of not taking the drug. It does NOT give permission to businesses to place "consequences" on employees who don't take the drug. The former gives the recipient the choice, the latter is coercive consent under duress.
-PJ