Statement given at the Open Public Hearing portion of the FDA Arthritis Advisory Committee meeting, February 9th, 2016
Good afternoon, my name is Thair Phillips, I’m the President of RetireSafe, a nationwide, non-profit, advocacy organization for older Americans. I’m here today representing our 300,000 supporters and almost 50,000 email activists.
RetireSafe looks forward to the promise of increased access offered by biosimilars but we continue to be concerned about safety. Our supporters, in response to a survey, overwhelmingly voiced their desire for, what they viewed as, common sense safe guards when it comes to the naming, labeling, switching, approved indications and the open communication required for biosimilars.
Our statement today will deal with safety issues both with the biosimilar being discussed today and with the overall biosimilar approval process.
In reference to today’s biosimilar, we are concerned that the FDA did not consider real world patient experience and instead relied on extrapolation of clinical data on two conditions (RA and AS) for approval of the other six conditions. The applicant apparently sites some small studies, but it appears FDA didn’t consider those studies.
We also found it troubling that at least one publicly available study that found significantly worse patient outcomes after taking the biosimilar was not included in the manufacturer’s submission. Equally troubling is the lack of any evaluation or discussion as to why Health Canada refused to approve this biosimilar for use in children and adults with Crohn’s disease.
The most troubling issue, however, is that FDA seems to have opened the door to a one-time switching of patients to this biosimilar when Congress has expressly required a finding of interchangeability for switching. This tacit re-assignment of status is a dangerous, precedent setting, action that threatens biosimilar safety at several levels.
The overall biosimilar approval process remains a threat to safety. We are concerned and baffled by FDA’s failure to release final guidance in many basic areas. We cite the following areas where the lack of final guidance and precedents established so far in the approval process threaten safety:
- The extrapolation of indications referenced above
- The seemingly lack of a requirement for clinical data to back the use for each indication
- A doctor’s label that may offer little or no information on the use for specific indications, especially any differences from the reference product
- The lack of specificity in the assignment of J-codes that will hinder adverse event tracking
- The projected lack of resources available to FDA to effectively approve biosimilars and to monitor their subsequent manufacturing and use
Americans trust the FDA. I personally heard Doctor Woodcock say in a House hearing last week that safety would not be sacrificed when it comes to biosimilars. I take her at her word. As a voice for the people you protect we ask that the questions and issues cited above be given appropriate consideration. To do otherwise would undermine the trust Americans have in the FDA.