Policies and procedures for petitions
The Department of Public Health, Drug Control Program accepts written petitions for addition of drug products to and other amendments to the Massachusetts List of Interchangeable Drugs (MLID). In accordance with regulations at 105 CMR 720.000, the Department's policies and procedures for submission and consideration of such petitions are summarized as follows:
- All proposals to the Department for amendments to the MLID shall be considered to be petitions and all petitions and other submissions must be addressed to the Director, Drug Control Program, 239 Causeway St., Suite 500, Boston, MA 02114.
- Not less than 60 days prior to the next scheduled meeting of the Drug Formulary Commission, petitioners must submit to the Drug Control Program 20 copies of petitions and supporting documents or data (e.g. bioequivalence, dissolution and other studies that support interchange) in accordance with criteria established by the Commission. The documents or data should be collated, tabbed, and indexed. The order of the documents should follow the order presented in Attachment A or B, found below. Complete petitions will be forwarded to the Commission for review.
- The Drug Control Program will make an effort to notify listed manufacturers of petitions concerning their products. A list of petitioners and drug products that are the subjects of petitions will be available, upon request, from the Drug Control Program not less than 50 days prior to the next Commission meeting.
- Manufacturers and other interested parties may respond to petitions, and petitioners may provide supplementary information (hereinafter referred to as supplementary submissions), by submitting to the Drug Control Program 20 copies of any documents concerning petitions not less than 35 days prior to the next meeting of the Commission at which such petitions will be considered. Such supplementary submissions will be forwarded to the Commission for review.
- Submissions that propose amendments that have previously been voted on by the Commission shall be considered to be petitions and not supplementary submissions and are subject to the policies and procedures for petitions set forth herein.
- The Commission will consider only those petitions and supplementary submissions that are received by the Drug Control Program on time. Consideration of petitions or supporting documents from petitioners that are not received on time will be deferred until a later Commission meeting. Supplementary submissions, including written responses, documents from responding parties, or supplementary documents from petitioners, that are not received on time cannot be considered at the meeting at which the petition will be considered. Such submissions will be included in the public comment period, if held, or any subsequent meetings at which the petition is considered. All documents submitted are public records.
- Public Records Law requests are fulfilled upon payment of a reimbursement fee to cover the costs incurred by the Commonwealth.
- The Drug Control Program will forward to the Drug Formulary Commission all petitions, supplementary submissions, and related documents submitted in accordance with the policies and procedures herein not less than two weeks prior to the Commission meeting at which such petitions will be considered. The preliminary agenda for the meeting will be available to the public, upon request, not less than two weeks prior to the meeting.
- The Commission will meet in public to review petitions and supplementary submissions, hear oral statements, at its discretion, and make recommendations to the Department concerning the disposition of petitions.
- The Department will incorporate the Commission's recommendations in the process of deciding upon the disposition of petitions and may incorporate said recommendations into a proposed amendment of the MLID. If the Department proposes an amendment of the MLID a public comment period will be held. The Department may consider factors other than Commission recommendations when deciding on the disposition of petitions, but will not consider a petition or supplementary submission that has not been reviewed and voted upon by the Commission.
- Written minutes, which are the official record of the Commission's meetings, are available to the public upon request, once they are approved by the Commission (usually at the next Commission meeting).
- After approval of the minutes and at the conclusion of the public comment period, the Drug Control Program will review the comments and evidence and prepare a report of its recommendations. If the Drug Control Program's recommendations differ substantially from those of the Commission, the Department will so report to the Commission.
- The Drug Control Program's recommendations for the proposed amendments will then be forwarded to the Commissioner of Public Health for consideration.
- Upon the approval of the Commissioner, the amendments will be forwarded to the Secretary of State for printing. The amendments take effect when they have been printed.