Learn about the role of the Advisory Committee and get details for the June 28 meeting on Ipsen's palovarotene capsules
Advisory Committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, vaccines and other biological products, medical devices, and food.
Does the FDA always use Advisory Committee meetings in the new drug application (NDA) review process?
FDA Advisory Committees are needed on a case-by-case basis in new drug application (NDA) review. Advisory Committee meetings are most common if it's a drug that has significant questions, if it's the first in its class, or the first for a given indication.
Who is on the Advisory Committee?
An Advisory Committee ordinarily consists of nine (9) fixed or "standing" members, including the chairperson. Members are selected because they are knowledgeable in expertise specific to the committee's function. Most committees will also have a Consumer Representative, Patient Representative, and an Industry Representative. The Industry Representative is a non-voting member, on the committee only for their expertise. The Advisory Committee should represent all geographic locations and be balanced as far as gender and minority status.
Advisory Committees are also supplemented with persons called Temporary Voting Members. These include patient representatives or medical personnel whose expertise may not be represented by the fixed voting membership.
View a list of the Advisory Committee members who will be participating in the meeting (also known as the Meeting Roster) here.
Are members of the Advisory Committee FOP medical experts?
Committee members are not FOP experts. However, they do come with expertise in evaluating the safety and efficacy of medications, understanding cumulative toxic effects, and weighing risks and benefits.
Doctors who are FOP experts and served as Principal Investigators in the trial will testify about the trial results alongside Ipsen representatives during the Advisory Committee meeting.
Is the Decision of the Advisory Committee the Decision of the FDA?
FDA Advisory Committees are just that, advisory, in nature. Therefore, the advice the FDA receives from the Committee does not represent the position of the FDA. The FDA weighs the advice that it receives from the Advisory Committee when taking action on new drug applications. The FDA makes the final decisions on all matters related to the NDA.
When is the FDA Advisory Committee meeting to review Ipsen's palovarotene capsules as a potential treatment for FOP?
The Metabolic Drugs Advisory Committee will meet on Wednesday, June 28, to review Ipsen's new drug application (NDA) 215559 for palovarotene capsules. The meeting is scheduled for 9:30 am to 5:30 pm ET and will be broadcast live on YouTube. The Open Public Hearing will take place from 2 to 3 pm ET. Members of the FOP community will share testimony during this one-hour period.
The YouTube link for the June 28 meeting, and all meeting materials, will be made public on June 26. The IFOPA will provide this YouTube link and meeting materials once they are publicly posted by FDA. Visit ifopa.org/calendar_of_events on June 26 for the link.
If you are active on social media during the June 28 Advisory Committee meeting, you are encouraged to use these hashtags.
#FDA
#EMDAC
#palovarotene
#FOP
If you are on Twitter, you can tag @US_FDA and @IFOPA.
Questions? Email us at [email protected]
