Patients are a Virtue -- but not at the FTC

  • by: |
  • 01/29/2014

Although FDA is tasked with creating naming policy for biosimilars before they enter the U.S. market, FTC is trying to force its misguided view on the issue in the hopes of building advocates for non-unique names. During a workshop scheduled for February 4 will delve into the biosimilars naming issue, but somehow they forgot to include a number of VIPs (Very Important Perspectives). Amazingly, patient advocates are nowhere to be found on the agenda; also absent are physicians who prescribe biologics and health system pharmacists.

Because of FTC’s slight – presumably so they could through the workshop arrive at near consensus on the need for biosimilars to share the same name as the innovators to which they related, and in doing so muddy the central facts that distinguishable naming is the right approach for efficient adverse event reporting, patient safety and even promoting uptake of and competition among biosimilars.

Today’s VIP on the issue is that of the first person – the actual long-time and life-long biologics user.  Donna Cryer is really a patient-plus though – in addition to using a mix of biologics and synthetic medicines for rheumatoid arthritis, inflammatory bowel disease, to preserve a transplanted liver she received nearly 20 years ago, and to deal with kidney issues that impair her body’s ability to make red blood cells, Donna is a Harvard-trained health policy lawyer, a patient representative on an FDA advisory committee and the first patient to serve as Chairman of the American Liver Foundation. Here’s Donna’s perspective on why the right naming policy for biosimilars and all biologics matters for her and the millions of other biologics users like her.

Q: What role do biologics play in treating patients?

A: Biologics play an incredibly important role in treating patients, like me, who have multiple autoimmune conditions. My life really depends on biologic medications. And for so many thousands of other patients, our health, our productivity, our ability to work and be with our families all are because we have access to biologic medications.

Q: What value could biosimilars offer to patients like yourself?

A: Biosimilars often offer lower cost options, so that can provide more access to medications for more patients.

Q: Why is it important for patients and doctors to know which biologic is being and has been put into a patient's body?

A: It is essential that doctors and patients know exactly which medication, particularly with biologics, they are prescribing and using. Being able to manage a disease based on the reactions of your immune system is really tricky. You want to make sure that you are not suppressing the immune system so much that you are open to every infection, every cold, as well as more serious conditions like tuberculosis.  Knowing exactly which biologic medication you're taking is absolutely vital because if there is a side effect, an adverse event, or just a change in your condition and your body's response, you want to be able to track it back to exactly the drug that you were prescribed, exactly the drug that you took.

Q: Since biologics are more complex than normal, chemical prescription medicines, how does that alter the conversation and relationship you have with your doctor?

A: The doctor/patient relationship is based on trust. In fact, the patient relationship within the entire healthcare system is based on trust, and a high degree of confidence, that what we're being prescribed, what we rely on for our very lives, is safe and effective. We want to be able to know, and have confidence that our biosimilars and biologic medications are distinguishable, so that we can know what we're taking, how we're taking it, how it differs.

Q: From your view as a patient, what would be the best approach the FDA could take when creating a naming policy for biosimilars?

A: Well, the issue of biosimilars naming is really important, because unless FDA ensures that unique distinguishable names for biosimilars are given, patients and doctors really will be left without any recourse to track back and understand what medication might have caused their adverse event or their side effect.  We want to be able to track back if there is an issue, a side effect, a serious adverse event, or just a change in our condition. We want to be able to know. We deserve the right to know what we have taken so that we can have recourse, if need be, about what has happened and what is happening to our bodies. As a patient, I'm not really sure why there is even an argument about having a distinguishable name for a biosimilar: it's such a simple solution to have a distinguishable name.

Thank you, Donna.



Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog