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June 9, 2011

RetireSafe Comments Regarding Options for a User Fee Program for Biosimilars


The Division of Dockets Management (HFA 305), Food and Drug Administration


5630 Fishers Lane, Room 1061, Rockville, MD 20852


Department of Health and Human Services, Food and Drug Administration 

[Docket No. FDA-2011-N-0326]



 RetireSafe, a non-profit senior advocacy organization representing over 400,000 seniors nationwide, is pleased to respond to your “Request for Comments” regarding “Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for Biosimilar and interchangeable Biological Product Applications for Fiscal Years 2013 through 2017.”

 As we have noted in our previous comments, RetireSafe has long been a strong and very vocal advocate for a biosimilar drug pathway that creates the correct balance between innovative new biologics and the “follow-on” biologics that seek to imitate and compete with the original biologic drug. RetireSafe supported the BPCI Act which was included as subtitle of the Patient Protection and Affordable Care Act (Public Law No. 111-148) and signed into law by the President. While we were outspoken supporters of the 12-year marketing exclusivity period included in the BPCI Act to preserve and protect future innovation, we were equally supportive of that provision to ensure an unhurried and very careful FDA process for the approval and subsequent use of biosimilars. Patient safety must be the absolute top priority in this process.


  We have also urged, on behalf of tens of millions of current and future older Americans, the most stringent and rigorous testing of biosimilars that would or could be used as replacements for the original, innovator biologic drugs. No group of Americans will be at greater risk from the unintended consequences of hastily approved and utilized biosimilars than America’s seniors. They will be the largest users of these drugs, and they will easily be the most vulnerable to dangerous side-effects, over-treatment, and under-treatment problems caused by a headlong rush to force them to use “cheaper” biosimilars that have nowhere near the pre-market and post-market testing of the original biologics they seek to replace. Millions of Medicare patients are clearly at the mercy of the new biosimilar regulatory pathway under the FDA’s purview. If it fails, they will suffer mightily as a result. Their lives are literally in your hands.



With those extreme perils in mind, RetireSafe has also advanced the belief that each and every biosimilar be tested in clinical trials similar to those required of the innovator drug. There can be no shortcuts in the biosimilar approval process. Every aspect of their development and production, manufacture and use must be given the same rigorous testing, inspection, and post-market surveillance as that rightly in place for innovator biologics seeking approval.


To accomplish and maintain the absolute rigor needed for biosimilars to be safely used in a future where appropriated FDA funding is constantly threatened, RetireSafe would strongly urge a Biosimilar User Fee Program that would match or even surpass the fees assessed under the Prescription Drug User Fee Act (PDUFA). As you note in the notice, determining biosimilarity or interchangeability of a proposed product is expected to be “comparably complex, technically demanding, and resource-intensive.” In our view, given the added complexity of ongoing substitution and safety issues which will demand even more post-market surveillance of an overall class of drugs that will one day dominate the market in use by older Americans, a good case can be made for higher 351 (k) fees for biosimilars. Again, RetireSafe wants to ensure that there are more than adequate resources on hand to guarantee the absolute safety and effectiveness of biosimilars when they are (as we know they will be) required to be used in senior health care programs like Medicare. Constant monitoring of substitution, safety, and manufacturing issues will be needed as biosimilar use becomes pervasive. Higher biosimilar user fees now and in the near term will help to meet the obvious future need


Again, RetireSafe urges you to consider patient safety as your paramount priority and responsibility. The biosimilar approval process will impact millions of older patients who will be depending on you and the work you do on their behalf. The user fee program will determine just how well FDA can do the job required. Thank you for the opportunity to comment, and for your consideration of our comments on this critical matter.



Thair Phillips, President


1616 H Street, NW, Suite 902
Washington, DC 20006










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