Archived Messages From the President
July 13th, 2016
Good afternoon, my name is Thair Phillips, I’m President of RetireSafe, a nationwide, non-profit, advocacy organization for older Americans. I’m here today representing our 300,000 supporters, including our 50,000 email activists. I have nothing to disclose concerning this testimony today. As I testified yesterday and at previous Advisory Committee meetings, RetireSafe looks forward to the promise of increased access offered by biosimilars but we are still concerned about safety. My statement today will again deal with safety issues that continue to exist within the overall biosimilar approval process.
Two years ago I reported on a survey we took concerning the safety and effectiveness of biosimilars. We felt it was necessary to update that survey since it has been so long. Again, both the answers and comments from our activists voiced an overwhelming desire for common sense safe guards when it comes to the naming, labelling, switching, approved indications and the open communication required for biosimilars.
While questions about safety always bring a positive result the percentages were unusually high, with most answers in the high 80s and one in the 90s. I will focus on two of the updated questions.
Over 95% of the respondents said that biosimilars should not be substituted if it had not been adequately tested for safety and efficacy specifically for the disease or condition it was prescribed to treat. This common sense answer should highlight the need for a change in how the Advisory Committee votes. I’ve been to every Advisory Committee meeting on biosimilars. At every meeting there are some indications that the committee members feel fine with and some that elicit questions and concerns. The up or down vote hides this valuable information. The Advisory Committee needs the option to have an up or down vote on each indication on a biosimilar’s application. This issue was our survey respondent’s number one concern.
A second question that elicited much interest concerned non-medical switching. Almost 86% of the people said that their medicine should not be switched for non-medical reasons. This type of switching has been one of the common themes we’ve heard from this podium. It is a complicated but very important consideration. To 86% of the mature Americans that answered our survey, changing a medicine that was working seems absurd, anybody with any common sense wouldn’t do it. Yet many stakeholders here today fear that it will, or has already begun to, become a reality. . . with good reason. You may not see how this type of switching is effected by your decisions or how it is something you have any control over. I think your decisions here and the decisions of the FDA do have an effect on non-medical switching. The requirement of all or nothing voting on indications masks the reservations you have voiced here concerning some indications. Labeling considerations that don’t reflect which indications were tested and which used extrapolated data hide critical information. Even FDA’s unexplained regression to favoring a non-meaningful suffix in the name hides important manufacturer information. All of these decisions make it easier for payers and PBMs to create formularies and guidance that promote non-medical switching, they even keep important information from doctors as they evaluate what’s best for their patients.
A patient, responding to our survey told us, quote;
“My RA has not progressed in any damaging manner. In fact, it improved the first few years and then stabilized. I use the biologic, Enbrel, and I don’t want any change.” Closed quote.
I wrestled with the decision to use this particular comment, for obvious reasons, but the fact of the matter is, this is an honest response to a serious question. It is also a fact that it has always been RetireSafe’s position that non-medical switching is not acceptable and it doesn’t matter whether it is to or from an innovator biologic, a biosimilar or a small molecule drug.
I am encouraged by your desire to broaden the scope of discussion at these Advisory meetings to deal with some of these important issues. The promise of biosimilars won’t be realized if we keep blinders on. We can’t be afraid of being spooked by something in our peripheral vision. That something may be the very thing that causes us to fail or succeed and shouldn’t be ignored.
Once again I’ll end by saying that Americans trust the FDA. Doctor Woodcock said that safety would not be sacrificed when it comes to biosimilars. I continue to take her at her word. As a voice for the people you protect, we ask that you work to broaden the discussion, realize the breadth of impact your decisions have and maybe listen a little more closely to the stakeholders. To do otherwise would undermine the trust Americans have in the FDA.