Regulatory Focus™ > News Articles > When is a Drug a 'New' Drug? Legislation Seeks to Change Definition

When is a Drug a 'New' Drug? Legislation Seeks to Change Definition

Posted 26 January 2015 | By Alexander Gaffney, RAC

When is a Drug a 'New' Drug? Legislation Seeks to Change Definition

New legislation introduced in the US House of Representatives last week seeks to incentivize the development of new combination drugs by redefining what a "new" drug really is.


Under existing rules administered by the US Food and Drug Administration (FDA), not all new drug products are treated the same. New chemical entities (NCEs) that have never before been approved in the US for any indication are eligible for five years of marketing exclusivity, during which time the product is immune from generic competition.

However, for drugs that have previously been approved for another indication—e.g. a drug first approved to prevent stroke that is now being approved to treat heart failure—FDA is only permitted to grant three years of marketing exclusivity.

This policy, clear in principle, has become tricky in practice for fixed-dose combination (FDC) drugs. Because many FDCs contain an already-approved active ingredient, FDA has traditionally determined that they are not a "new" drug, and are therefore only eligible for three years of marketing exclusivity.

Then, in October 2014, FDA changed its FDC policy following petitions from several pharmaceutical manufacturers arguing that their drugs were in fact "new drugs" eligible for five years of marketing exclusivity.

Under FDA's new understanding, the regulator said it would judge the New Chemical Entity (NCE) status of "each drug substance in a drug product" instead of "the drug product as a whole."

"As a result, an application for a fixed-combination submitted under section 505(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) will be eligible for 5-year NCE exclusivity if it contains a drug substance, no active moiety of which has been approved in any other application under section 505(b).30," FDA explained. "For example, a fixed-combination drug product that contains a drug substance with a single, new active moiety would be eligible for 5-year NCE exclusivity, even if the fixed-combination also contains a drug substance with a previously approved active moiety."

As reported by Regulatory Focus, the change in policy was a welcome relief for some—but not all—manufacturers of FDCs. FDA said its policy would not be retroactive, and therefore all existing manufacturers of FDCs were out of luck.

New Legislation

Now new legislation introduced by Rep. Jason Chaffetz (R-UT) is set to change how FDA accommodates FDC applications on a statutory level.

The legislation, known as the Combination Drug Development Incentive Act of 2015, would modify Clause (ii) of section 505(c)(3)(E) of the FD&C Act, which now prohibits FDA from treating as a "new drug" any product containing an already-approved "active ingredient (including any ester or salt of the active ingredient."

The new definition of drug under that section would explicitly allow FDA to approve as a new drug an FDC which:

  • Relies on new clinical data that is considered "essential to the approval of the application"
  • The drug is a combination product containing a combination of "active ingredients" that has never before been approved "in any other application."

As with FDA's policy, however, the legislation is not set to be retroactive. The new definition would go into effect as of 1 January 2016.

"As the law is currently written, virtually all combination new drugs are excluded from the five years of market exclusivity and therefore are not being developed," said Chaffetz in a press statement. "A new drug that has been created using one or more existing molecules should not be required to go through the same rigorous, lengthy and expensive FDA new drug approval process."

Chaffetz' bill was previously introduced in 2013 prior to FDA's change in FDC policy.


Combination Drug Development Incentive Act of 2015

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