Section 564 of the Food , Drug, and Cosmetics Act
("FDCA") provides that the Food and Drug Administration 's ("FDA") standard process for approving
drug s and biologics may be suspended in the case of
emergency. In place of the FDA's rigorous standard
"approval" process, Section 564 provides that where a
requisite emergency has been declared , drugs and biologic al products may be released into interstate commerce so long as they have proceeded through Section
564's "authorization" process. The "authorization"
process provided in Section 564 is largely within the
discretion of the Secretary of the Department of Health and Human Services, allowing the Secretary
to "authorize" a particular drug or biological product
if its known and potential benefits outweigh its known
and potential risks. Section 564 of the FDCA provides
all recipients of "authorized" drugs or biologic al products the right to refuse receipt of such drug or biological product.

Question 1:
Is there a violation of Section 564 's guarantee of a
right to refuse when an employer imposes adverse employment consequences on employees who refuse to
accept a vaccine that has been authorized but not approved by the FDA, such that Petitioners' claim in this
case under the Illinois Whistleblower Act should have
been permitted to proceed ?

Title VII of the Civil Rights Act of 1964 prohibits
an employer from engaging in employment discrimination on the basis of religion . Prior to bringing a
claim in Federal Court for religious discrimination, a
party must first exhaust his/her administrative remedies by obtaining a r ight-to-sue letter from the Equal
Employment Opportunity Commission ("EEOC") .

Question 2:
Is dismissal of a complaint with prejudice for failure
to exhaust administrative remedies an appropriate
remed y where plaintiffs have informed the court that
they can cure this deficiency in their complaints because they have either obtained right -to-sue letter s or
are in the process of obtaining them?

Question not identified.