WASHINGTON--(BUSINESS WIRE)--On July 16, 2014, Council for Citizens Against Government Waste (CCAGW) President Tom Schatz, joined by pro-taxpayer groups FreedomWorks and Taxpayers for Common Sense, and the non-profit public policy group Competitive Enterprise Institute, sent a joint letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg urging the agency to maintain the same International Nonproprietary Name (INN), or generic name, for an originator (reference) biologic product and an equivalent biosimilar. Biologics are medical products made by living organisms, and biosimilars are the copies of the reference or branded product. Whether the biosimilars should share the same INN with reference biologics has become a controversial topic within the FDA and among stakeholders. The letter to Dr. Hamburg reads in part as follows:
“It has been more than four years since the BPCIA was signed into law as part of the Affordable Care Act (ACA.) Yet, not one biologic product has been approved by the FDA as a biosimilar or interchangeable product. The Congressional Budget Office estimated that competition from biosimilars would reduce drug spending by roughly $25 billion over 10 years, saving the federal government nearly $6 billion. But rather than simply following Europe’s decision to allow a biosimilar to share the same INN as its reference product, the FDA is wasting valuable time and resources contemplating whether it should require different nonproprietary names for biosimilars.
In a May 2012 joint comment to FDA’s draft biosimilar guidances, the American Pharmacists Association, the National Association of Chain Drug Stores, and the National Community Pharmacists Association expressed their opposition to having a different INN for a biosimilar. They said, ‘the use of different INNs would increase the burden of being able to distinguish which products are biosimilar and interchangeable with which reference drug and may pose difficulties in recognizing the best alternative drug for therapeutic use in a timely manner. Such confusion may lead to medication errors such as therapeutic duplication. Furthermore, unique INNs would be contrary to the World Health Organization (WHO) naming system that is accepted globally, causing confusion within the global marketplace.’ We agree with their assessment.
Furthermore, six senators who served on the Senate Committee on Finance or the Senate Committee on Health, Education, Labor, and Pensions when ACA was being crafted, stated in an October 23, 2013 letter to you that they believe ‘BPCIA prohibits the FDA from approving a biosimilar with pharmacologically relevant differences from the brand product, thus no unique name should be required for a FDA-approved biosimilar.’
As you know, the INN was created by the World Health Organization (WHO) in order to identify pharmaceutical substances and this system has been in use for more than 60 years. The INN currently includes approximately 7,000 unique, globally-recognized names. According to the WHO, ‘the existence of an international nomenclature for pharmaceutical substances, in the form of INN, is important for clear identification, safe prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.’”
The letter can be viewed in its entirety here.
The Council for Citizens Against Government Waste is the lobbying arm of Citizens Against Government Waste, the nation’s largest nonpartisan, nonprofit organization dedicated to eliminating waste, fraud, abuse, and mismanagement in government.
