FDA Proposes New Policy to Boost Development of Fixed-Combination Drug Products

“FDA’s new interpretation of these terms would result in a determination of 5-year [New Chemical Entity] exclusivity for each active ingredient in a drug product instead of the drug product as a whole.”  (Carlson Caspers)

The Food and Drug Administration has proposed a policy change that should give combination therapies a shot in the arm. The background, from attorneys at Wilson Sonsini:

“Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug Administration approved 19 new drug applications (NDAs) for fixed-dose combination drugs containing at least one new drug substance. More than half of these NDAs were approved in the last seven years.”

In response to pressure from the pharmaceutical industry, the FDA has proposed a new policy that should boost the development of combination therapies: a five-year exclusivity on fixed-combination drug products that contain at least one new ingredient. Attorneys Carolyn Alenci and Frederick Ball of Duane Morris explain:

“In order to incentivize the development of fixed-combination products, this month the FDA has issued a draft Guidance for Industry that proposes the term ‘drug’ in these provisions should be interpreted to mean ‘drug substance’ or ‘active ingredient.’ Under this definition, the ‘5-year NCE exclusivity determination will be made for each drug substance in a drug product, not for the drug product as a whole.’”

And that’s good news for the industry. Again, Wilson Sonsini:

“Increased market exclusivities, which will take effect when the FDA finalizes the guidance, will be important to all organizations developing fixed-dose combination drugs. They also will be important to small, venture-backed pharmaceutical companies, as they can increase licensing royalties, company valuations, and post-merger or acquisition earn-outs. Finally, increased market exclusivities will affect the timing of the introduction of generic combination drug products.”

The FDA is seeking public comments on the change through April 25, 2014.

The updates:

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