Email from CDER:
Thank you for your emails of October 17, 2013, November 14, 2013 and November 20, 2013, regarding the October 16, 2013 Endocrinologic and Metabolic Drugs Advisory Committee meeting, which discussed granting the drug Vascepa (icosapent ethyl) an indication for co-administration with statin therapy to lower serum triglycerides and other lipids in patients with mixed dyslipidemia and coronary heart disease or its risk equivalent.
The Food and Drug Administration (FDA or Agency) takes seriously all comments and concerns about advisory committee proceedings and FDA personnel. The Agency is committed to ensuring that the drug review and advisory committee processes are conducted professionally and in accordance with applicable statutes and regulations. Furthermore, the Agency recognizes the value of making these proceedings transparent to the American public. Part of the FDA's mission is to help the American public get the accurate, science-based information they need to use medicines that maintain and improve their health.
To that end, FDA rigorously evaluates all data submitted in support of a New Drug Application treatment indication. A team of FDA physicians, statisticians, chemists, pharmacologists, and other scientists independently and objectively evaluate the data in the application to determine whether the drug may be approved for the proposed indication. As a part of the review process, the FDA often requests outside advice from an advisory committee when the data raise challenging or novel scientific issues relating to the drug's use.
FDA strives to have broad representation of appropriate medical and scientific specialties on its advisory committees. The Agency screens advisory committee members for financial conflicts of interest and relationships that could present even the appearance of a conflict. After thorough review of the background materials and consideration of comments made by the applicant, the FDA, and the public, the committee members provide the Agency with their informed judgment. FDA highly values the expertise of the independent experts on the committee and incorporates the advisory committee assessments into its decision-making process; however, advisory committee votes and recommendations are not binding on the Agency.
My Reply:
To whom it may concern,
Thank you for your response. It is nice to know ordinary citizens can still communicate with government agencies. One question regarding your response. You state, "As a part of the review process, the FDA often requests outside advice from an advisory committee when the data raise challenging or novel scientific issues relating to the drug's use", to which I assume translates into whether or not the FDA believes reducing triglycerides in the Anchor Indication will have a positive effect on coronary heart disease or its risk equivalent. My question is what was the date that the FDA came to this conclusion? The reason I ask is that the FDA quoted the three studies (Accord-Lipid, Aim-High and HPS2-Thrive) as the reason for the "new science" and these studies results were available to the FDA prior to the sNDA letter being sent and obviously before the Adcom. Why would the FDA, with this information, allow a public company to continue on a dead end path if the decision was already made?
AI
