an application has been submitted or approved under section 505(j) shall not be considered ineligible for approval under that section or misbranded under section 502 on the basis that the labeling of the drug omits information relating to a disparity on the basis of racial or ethnic background as to the safety or effectiveness of the drug, whether derived from investigations or studies required under this section or derived from other sources, when the omitted information is protected by patent or by exclusivity under section 505(j)(5)(F). (2) Labeling Notwithstanding paragraph (1), the Secretary may require that the labeling of a drug approved under section 505(j) that omits information relating to a disparity on the basis of racial or ethnic background as to the safety or effectiveness of the drug include a statement of any appropriate contraindications, warnings, or precautions related to the disparity that the Secretary considers necessary. (d) Definition The term evidence that there may be a disparity on the basis of racial or ethnic background as to the safety or effectiveness , with respect to a drug or biological product, includes— (1) evidence that there is a disparity on the basis of racial or ethnic background as to safety or effectiveness of a drug or biological product in the same chemical class as the drug or biological product