Today the Federal Trade Commission is conducting an workshop to determine, in part, if follow-on versions of biologic medications will have the same name as the original versions of the medications or if they will be designated by a distinguishable name or code so if there is an adverse event the doctors, patients, and regulatory agencies can track back and find the responsible product. They would still be on the market, still be (presumably) at a lower cost, but just not able to hide. What do you think?
Below is a link to my views in a conversation with former Asst. Commission of FDA, Peter Pitts and a blog post from the Alliance for Patient Access which includes a letter signed my major patient associations.
Drugwonks Interview: http://drugwonks.com/blog/patients-are-a-virtue-but-not-at-the-ftc
Blog Post from the Alliance for Patient Access
By Brian Kennedy, Alliance for Patient Access
As a representative of an organization that advocates for greater patient access to approved therapies and appropriate clinical care, I am hopeful that when biosimilars are introduced into the U.S. market (later this year or early next), patients nationwide will have increased access to certain life-altering and life-saving treatments. It’s disappointing though that the Federal Trade Commission (FTC) is driving a discussion about market access and competition for biologics and biosimilars this week, yet they left important perspectives – namely patients, providers with experience prescribing biologics, and health system pharmacists – out of that dialogue.
While the U.S. Food and Drug Administration (FDA) – not the FTC – ultimately sets federal policy around the approvals pathway for biosimilars, any public discussion driven by a federal government agency is going to get attention; because of the FTC’s omission of these important perspectives, the Alliance for Patient Access (AfPA), along with the California Healthcare Institute (CHI) and thirteen other health advocacy organizations, signed a letter that has been submitted to the FTC and urges that patient safety and consumer protection be at the forefront of the FTC’s considerations, particularly when discussing the issue of the naming of biosimilar products.
Before approving biosimilars in the U.S., FDA will first need to establish naming policy for these products. Given the vast differences between chemical compounds and biologics – including biosimilars, the FDA should require distinguishable names for all biologic products, rather than requiring biosimilars and their innovator reference product to share the same name.
Patients across the country will be best served if distinguishable names are required for all biologics. By providing clarity of which medication is being recommended at the point of prescription, distinguishable names facilitate the process of determining the cause of an adverse effect and allowing patients and their medical teams route back to the origin of the problem. Issues that may be particular to a specific biological product may even be entirely untraceable without distinguishable names or other distinct identifiers.
Accordingly, through the way it sets naming policy, FDA can provide the best possible protection for patients, while simultaneously ensuring the highest credibility for biosimilars as they enter the marketplace.
FTC Workshop on Competitive Impacts of State Regulations and Naming Conventions Concerning Follow-on Biologics: http://www.ftc.gov/news-events/press-releases/2013/11/ftc-host-workshop-competitive-impacts-state-regulations-naming