Testimony given at the Open Public Hearing portion of the FDA Arthritis Advisory Committee meeting, July 12th, 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. As I’ve stated at previous Advisory Committee meetings, RetireSafe looks forward to the promise of the increased access offered by biosimilars but we are still concerned about safety. My statement today will deal with safety issues that continue to exist.
It is beyond amazing that after meetings and hearings and biosimilar approvals we are still without critical final guidance. It is difficult to imagine what scenario or motive would explain this lack of movement. 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 again unusually high with most answers in the high 80s and one in the 90s. I don’t have time today but I’ll talk more about the survey tomorrow at the next AdCom meeting. I will say that we had multiple comments about the importance of testing each indication and non-medical switching. These survey respondents are concerned Americans who continue to feel left out of the process. As you may have already heard, many of the stakeholders here today feel left out.
It’s imperative that today I discuss cost. In the Biologics Price Competition and Innovation Act (BPCIA), Congress specifically limited FDA’s scrutiny to:
- Assuring no clinically meaningful differences in safety and effectiveness, and;
- Determining biosimilarity.
By Congressional and FDA’s own direction cost should not enter into the conversation, yet the following quotes are taken from the February AdCom meeting concerning a biosimilar for Infliximab, I quote:
“…So the real purpose of this and the reason behind this pathway is to provide access and to reduce cost.” Closed quote.
The second statement, and I quote:
“For all of these reasons and because we have the responsibility to take a risk to provide new products that are biosimilars, to reduce the cost of bringing drug to market, and to reduce the cost to patients, we really need to go ahead and take this risk.” Closed quote.
Again, cost is not one of the areas for review and accepting more risk to reduce cost is not a goal. Determining safety, effectiveness and biosimilarity are the only goals, cost should not enter into the conversation.
Finally, this week we have a unique opportunity to gain some unfiltered insight. Within a two-day span Amgen will be both a biosimilar applicant and a manufacturer whose innovator drug has a proposed biosimilar. Amgen may have the best perspective and be the best source of unencumbered facts about many of the safety issues we have discussed in the last two years.
Let me touch on two of those safety issues. To the best of my knowledge Amgen believes that a biosimilar should have a distinct suffix that identifies the manufacturer and Amgen does not support non-medical switching. While RetireSafe and others may not agree with Amgen on every issue, I think most of us testifying today agree on these two issues and possibly others. I think the Advisory Committee and the FDA should pay special attention to Amgen’s stance on these two safety issues.
I’ll end as I have ended past testimonies, Americans trust the FDA. I personally heard Doctor Woodcock say in a House hearing 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.