Policy Wonk Steve on why the recent FTC workshop on this hot naming controversy was a travesty
Few people outside of the Washington, DC beltway of policy wonks knew about a workshop hosted by the Federal Trade Commission (FTC) on February 4th. I’m here to tell you that many more should have, most notably: patients. Even further, patients should have been invited to formally participate. Instead, they were not and the consequences have the potential to be harmful. The FTC workshop - which was held to explore competition issues involving biologic medicines and follow-on biologics (aka biosimilars) - was a clear example that the fight to include the patient perspective is needed now more than ever.
So what’s a biologic and a biosimilar? A biologic medicine is a large molecule typically made from living cells and used in the treatment, diagnosis or prevention of disease. Biologic medicines include therapeutic proteins, DNA vaccines, monoclonal antibodies and fusion proteins. What you need to know is that these meds are extremely complex (often 200 to 1,000 times the size of your standard small molecule drugs). They are also highly sensitive, making them more difficult to characterize and produce.
Unlike generic medicines where the active ingredients are identical, biosimilars – by definition – are not likely to be identical to the originator biologic. They are similar, but not the same. Don’t get me wrong, biosimilars are great – we love them. Biosimilars hold great promise in their ability to increase access for patients to life-saving cutting edge therapies.
Back to the workshop. Why was the FTC involved on this issue and not the FDA? That’s the million dollar question. Here’s the short answer. In February 2012, the FDA issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. What, if any, additional guidance FDA may issue, and when, is uncertain. Consequently, that leaves a lot of grey area around an extremely impactful burgeoning market. Enter the FTC, and its interest to ensure that “anti-competitive” or “deceptive practices” don’t compromise a consumer’s ability to know which product he or she is prescribed.
What the FTC is really after here is whether a biosimilar that follows a biologic “reference product” (the innovator) ought to have the exact same name as that reference product. From the patient perspective, the answer is easy: no. Look at it this way; a human and a chimpanzee are 98.8% genetically similar. Do we have the same names? We are similar, but not the same.
In order to help inform their decision, the FTC invited many stakeholders to formally speak and weigh in on the topic. Innovator companies, biosimilar manufacturers, pharmacies, independent consultants, academics, prescription benefits managers and research analysts. Notice anyone missing? The end user, the consumer of the products that are being discussed; the patient! The FTC’s failure to include the patient perspective was absolutely unacceptable. As a result, valuable concerns and insights were lost:
- For patients, the core concerns are to safeguard safety and the physician-patient relationship.
- The physician-patient relationship is all about trust. Patients want to know that what they’re being prescribed is safe and effective.
- If a patient experiences an adverse event, side effect, or change in their condition, they want their physician to be able to quickly track which biologic or biosimilar medication was given.
- Patients want to have confidence that their biosimilars and biologic medications are distinguishable, so that they can know what they’re putting into their bodies. Is that so much to ask?
As patient advocates we need to have the opportunity to convey these perspectives to the decision makers. The perspectives that have come directly from you. When agencies like the FTC prevent patients and their advocates from sharing the personal point of view, the emphasis shifts from people to products. We as a community must be vigilant in preventing travesties like the one that took place at the FTC on February 4th.
Connect with Steve: