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An examination of exclusivity
September 2013
by Kelsey Kaustinen  |  Email the author


SILVER SPRING, Md.—A trio of pharmaceutical companies are petitioning the U.S. Food and Drug Administration (FDA) to amend the Food, Drug and Cosmetic Act and its stance on granting exclusivity to fixed-dose combination medications. Gilead Sciences, Ferring Pharmaceuticals and Bayer HealthCare are all seeking five years of New Chemical Entity (NCE) exclusivity for their respective products on the argument that each of their medicines contains an active ingredient that has never been part of an approved new drug application, even if they all also contain previously approved active ingredients.  
Gilead is petitioning the FDA concerning STRIBILD Tablets, its treatment for HIV, while Bayer's petition is focused on its oral contraceptive NATAZIA and Ferring's for Prepopik, a preparation drug for colonoscopies.
In brief, the section of the Food, Drug and Cosmetic Act under question states that if an application is submitted to the FDA for a drug, and none of its active ingredients have been approved in any other application under the Act, no application can be submitted under the subsection of the Act before five years from the approval date of the application. The act also states that, "If a drug product that contains a [NCE] was approved … no person may submit a 505(b)(2) application or [ANDA] … for a drug product that contains the same active moiety as in the [NCE] for a period of five years from the date of approval of the first approved [NDA]."
According to the FDA Law Blog, the official blog of Hyman, Phelps & McNamara PC, "the FDA's long- standing position has been that in order for a fixed-dose combination drug to be eligible for five-year NCE exclusivity, each of the active moieties in the drug product must be new (i.e. not previously approved)." As such, the FDA has generally denied NCE exclusivity if any previously approved active moieties are present and granted three-year exclusivity instead.  
On Aug. 2, Rep. Jason Chaffetz, R-Utah, introduced a new bill addressing this issue, the Combination Drug Development Incentive Act of 2013. The bill's full title on is listed as "To amend section 505 of the Federal Food, Drug and Cosmetic Act to provide incentives for the development of new combination drugs." Chaffetz's bill was assigned to the Energy and Commerce Committee. Rep. Howard Coble, R-N.C., and Rep. Matt Salmon, R- Ariz., are listed as co-sponsors for the bill.
The bill recommends that the Federal Food, Drug and Cosmetic Act should be amended to give new drug products five-year market exclusivity if they contain a combination of active ingredients that have not been approved for combined use previously. A spokeswoman for Chaffetz's office explained, "the legislation would give a new drug product—which contains a combination of active ingredients that have not previously been approved for use together—the same period of market exclusivity—five years— as a drug product containing a new active ingredient."
"While current law provides strong incentives to invest in R&D for combinations of entirely new combination drugs—composed of brand-new molecules—it provides much lesser incentives to invest in R&D for combinations that include one or more previously approved drug molecules," the spokeswoman said in a statement to the FDA Law Blog. "On top of that, it is getting more and more difficult and expensive to discover brand-new molecules.  
"Additionally, the FDA requires applicants for new combination drugs to demonstrate safety and efficacy in human clinical trials. The showing of efficacy must be against not only a placebo, but against each of the components separately. The process is both expensive and time-consuming and requires considerable capital." gives the bill a 5-percent chance of getting past committee and a 1 -percent chance of being enacted, noting that "only 11 percent of bills made it past committee and only about 3 percent were enacted in 2011-2013."
Code: E091327



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