Redefining What a New Drug Really Is

New legislation was introduced in January of 2015 which seeks to change the way a new drug will be defined and, eventually, the amount of manufacturers interested in creating combination drugs. As a combination manufacturer, you will need to know how this specific legislation will affect you and how new combination drugs will be defined as well as how other companies may receive incentives to start manufacturing these products.

The Legislation

Introduced by Rep. Jason Chaffetz (R-UT), the Combination Drug Development Incentive Act of 2015 seeks to modify a clause of the FD&C act which prohibits the FDA from treating any drug product as new if it contains an active ingredient which has already been approved (even if it was approved for another purpose).

The legislation will redefine the term “new drug” to include any FDCs (fixed-dose combinations) which now depend on new data that was unknown before to the FDA. This is essential to the acceptance of the combination product. New drug must also contain a combination of ingredients (must be active) that have never before been approved in another application.

The FDA’s FDC Policy

This has all come as a result of an October 2014 change to the FDA’s policy for fixed-dose combinations, which states that drugs will now be judged on whether or not they should receive new chemical entity (NCE) status based on each substance in the product and not merely the product as a whole.

The former policy caused any combination drug that contained a previously-approved ingredient (which are many of them) to not receive the NCE status. Now, along with the legislation and the changes made to the FDA’s FDC policy, many new combination drugs may receive NCE status, meaning that they could be eligible for:

  • Five years of exclusivity instead of three years
  • Immunity for those five years from any generic competition
  • The ability to label the drug as a new product as long as it contains:
    • A new active ingredient
    • A new combination of active ingredients that have not been used before
    • New data that is essential to its use or application

What Does This Mean for You?

The legislation itself is being introduced in order to bolster the development of new combination drugs and to incentivize manufacturers to create new combination drug products. Your combination products manufacturing organization will need to determine how this can affect you and whether or not you may need to make any changes to your policies.

  • Unfortunately, the changes in both the FDA’s policies and the new legislation will not retroactively affect drugs that have already been approved. The legislation’s new definition will not go into effect until January of 2016 and any drugs previously approved will not be affected.
    • This has caused issues among many manufacturers of FDCs.
  • These changes are being made in order to incentivize companies to create more combination products, so there may be more manufacturers joining the market as a result.
    • It could cause more competition for established manufacturers such as your company.
    • On the other hand, it may generate more interest in and funding for these particular types of combination products as well.
  • Any products approved after the policies are approved will be provided NCE status for five years instead of three.
    • This means that the manufacturer of said products will receive two extra years of no competition from the creation of generic brands, giving them more time to promote their product exclusively to the specific market.

The development of new combination drugs is not as common as other products and that is why these changes are being made. It’s a way to motivate more manufacturers and companies to create combination products. The changes being made to define the term “new drug” have many effects on manufacturers as well as on the definitions of drug products themselves.

Understanding these decisions and why they are being made is key to the success of your organization. And, with the right strategy, these changes may be beneficial to your organization in the long-term.