Approval pathway proposed for significant drug combinations

Earlier this month, US Congressional Representatives Brian Bilbray (R-CA, Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT) introduced House Resolution 6502, the Life-Threatening Diseases Compassion through Combination Therapy Act of 2012. The intent of this legislation is to create a new “significant drug combination” category for FDA review. If enacted, the bill would amend the Federal Food, Drug and Cosmetic Act to state:

The Secretary may designate a combination of drugs as a significant drug combination if such combination of drugs 

(A) includes 2 or more drugs (which may include one or more biologics subject to licensure under section 351 of the Public Health Service Act) that 

(i) when used in combination, offer the potential to significantly advance treatment for a serious or life-threatening disease;

(ii) in combination, meet the criteria for codevelopment of drug combinations, as specified in the Food and Drug Administration’s guidance document entitled “Guidance for Industry: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination” or a successor document; and

(B) includes at least 2 drugs that are not approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act.

Additionally, the drug combination would have to “significantly advance treatment” of one or more conditions for which no other therapy exists, or be shown to improve outcomes when compared to existing therapies in active controlled trials.

Proposed incentives for industry include priority review and an extension of marketing exclusivity. A new FDA task force would be charged with developing a list of recommendations on the types of drug combinations that should be designated as significant drug combinations. The list would be made available for public review and comment, and would be updated annually. The task force would also study and comment on issues related to the codevelopment of drugs in significant drug combinations.

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