Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78 Fed. Reg. 67985 (proposed Nov. 13, 2013).

ANSWERING THE SUPREME COURT’S CALL -

The proposed rule directly responds to Justice Thomas’s declaration, for the majority in PLIVA v. Mensing, that the Supreme Court “will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme. As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.” PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2852 (2011).