; and (2) the article’s author or researcher or author’s institution (or, in the case of multiple authors, researchers, or institutions, all such authors, researchers, or institutions) received less than 30 percent of funding for such research from the Department of Health and Human Services throughout the period of time the research was conducted. (g) Informed Consent Prior to receiving a drug provisionally approved under this section, the sponsor of the drug shall receive from each patient, or the patient's representative, informed consent, through a signed informed consent form, acknowledging that such patient understands that the drug did not undergo the usual process for approval of a drug by the Food and Drug Administration, and that such patient is willing to accept the risks involved in taking such drug. (h) Postmarket controls and labeling (1) FDA annual review of registry data The Secretary shall annually review the data made available through the observational registries under subsection (d) and make a determination regarding whether the side effect profile of any drug provisionally approved under this section does not support the benefit provided, or the data shows the benefit is less than the benefits offered through other, fully approved drugs. (2) Labeling The sponsor of the provisionally approved drug shall ensure that all labeling and promotional materials for the drug bear the statement provisionally approved by the FDA pending a full demonstration of effectiveness under application number ______ (specifying the application number assigned by the Secretary in place of the blank). All promotional, educational and marketing materials for provisionally approved products shall be reviewed and approved by the Secretary before such materials are distributed. (3) Rescission of provisional approval If the Secretary determines that the side effect profile of any drug included in such observational registries does not support the benefit provided by such drug, or that the data shows that the benefit is