Too many Americans struggle with the high cost of drugs. In some cases, patients go without needed medicines. This is why drug pricing is a matter of public health. And it’s why FDA launched a Drug Competition Action Plan that focuses on three key areas designed to facilitate more generic competition, promote patient access, and improve the economics of developing generic medicines.
While we’ve made substantial progress in fostering more competition by resolving obstacles that can make it difficult to win approval of generic versions of certain complex drugs, increasing the speed of generic approvals, and closing down ways that branded companies game the system to prolong drug monopolies, there’s still more work to be done.
So we’re opening up some new policy fronts when it comes to our Drug Competition Action Plan. And we’re re-launching that plan for 2019 with some additional initiatives. Chief among them is a new effort that FDA has proposed to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), a key international body comprised of other regulatory authorities and the pharmaceutical industry: The pursuit of common global development standards for generic drugs.
The idea is straightforward. We want to advance the international harmonization of scientific and technical standards for generic drug development. Generic drug developers should be able to implement a single global drug development program and utilize common elements of applications to file for approval in multiple markets. This would make it easier for developers that would otherwise only seek generic drug approval in one region to also seek approval in the United States, increasing competition in America. And it would also make it easier for developers that would otherwise only seek generic drug approval in the U.S. market to gain access to other markets. For example, FDA has adopted the electronic "Common Technical Document" (eCTD), an agreed-upon format for drug applications across international regulatory bodies that, among other things, decreases the burden on developers seeking marketing approval for a drug product in multiple regions by allowing them to submit data and information organized in the same way to multiple pharmaceutical regulators. But we can do more, and further work could standardize the scientific and technical requirements for generating the data submitted in that common format.
The ultimate goal of this global harmonization of scientific and technical requirements would be the attainment of a single global generic drug development program that can support simultaneous regulatory filings across multiple markets. Harmonization of these requirements is foundational to achieving a future goal of enabling global approval for high quality generic drugs.
International Harmonization of Generic Drug Standards Can Increase Market Competition
Currently, manufacturing specifications may differ between countries, and different types of tests may be required to support the approval of a generic drug in different countries. For example, right now a specific drug may need to be tested under different dissolution methods and acceptance criteria to satisfy both the FDA and the European Medicines Agency’s (EMA) regulatory requirements.
The lack of harmonization across such basic components of generic drug development reduces the opportunities for generic drug developers to use their data and information across multiple applications in different jurisdictions. The result is increased cost and complexity to the generic drug development and approval process, which makes it more difficult for generic drug developers to file applications for approval in different markets for a generic drug.
As a consequence, generic drug developers with limited resources sometimes must choose only a limited number of countries where they’ll apply for marketing approval. In some markets, a generic drug developer may not seek approval for a generic drug at all. These decisions can limit competition, increase prices, and increase the risk of shortages.
Given the globalization of generic drug development and the basi...
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