; (B) to remove such a drug for which a safety problem is found; and (C) to add a drug that the Secretary identifies as a drug which treats a condition for which there has not previously been a treatment option or for which a clear and significant benefit has been demonstrated over other covered part D drugs. (4) Adding drugs to the initial formulary (A) Use of advisory committee The Secretary shall establish and appoint an advisory committee (in this paragraph referred to as the advisory committee )— (i) to review petitions from drug manufacturers, health care provider organizations, patient groups, and other entities for inclusion of a drug in, or other changes to, such formulary; and (ii) to recommend any changes to the formulary established under this subsection. (B) Composition The advisory committee shall be composed of 9 members and shall include representatives of physicians, pharmacists, and consumers and others with expertise in evaluating prescription drugs. The Secretary shall select members based on their knowledge of pharmaceuticals and the Medicare population. Members shall be deemed to be special Government employees for purposes of applying the conflict of interest provisions under section 208 of title 18, United States Code, and no waiver of such provisions for such a member shall be permitted. (C) Consultation The advisory committee shall consult, as necessary, with physicians who are specialists in treating the disease for which a drug is being considered. (D) Request for studies The advisory committee may request the Agency for Healthcare Research and Quality or an academic or research institution to study and make a report on a petition described in subparagraph (A)(ii) in order to assess— (i) clinical effectiveness; (ii) comparative effectiveness; (iii) safety