An examination of exclusivity

SILVER SPRING, Md.—A trio of pharmaceutical companies arepetitioning the U.S. Food and Drug Administration (FDA) to amend the Food, Drugand Cosmetic Act and its stance on granting exclusivity to fixed-dosecombination medications. Gilead Sciences, Ferring Pharmaceuticals and BayerHealthCare are all seeking five years of New Chemical Entity (NCE) exclusivityfor their respective products on the argument that each of their medicinescontains an active ingredient that has never been part of an approved new drugapplication, even if they all also contain previously approved activeingredients.

Gilead is petitioning the FDA concerning STRIBILD Tablets,its treatment for HIV, while Bayer's petition is focused on its oral contraceptiveNATAZIA and Ferring's for Prepopik, a preparation drug for colonoscopies.

In brief, the section of the Food, Drug and Cosmetic Actunder question states that if an application is submitted to the FDA for adrug, and none of its active ingredients have been approved in any otherapplication under the Act, no application can be submitted under the subsectionof the Act before five years from the approval date of the application. The actalso states that, "If a drug product that contains a [NCE] was approved … noperson may submit a 505(b)(2) application or [ANDA] … for a drug product thatcontains the same active moiety as in the [NCE] for a period of five years fromthe 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 inorder for a fixed-dose combination drug to be eligible for five-year NCEexclusivity, each of the active moieties in the drug product must be new (i.e. notpreviously approved)." As such, the FDA has generally denied NCE exclusivity ifany previously approved active moieties are present and granted three-yearexclusivity instead.

On Aug. 2, Rep. Jason Chaffetz, R-Utah, introduced a newbill addressing this issue, the Combination Drug Development Incentive Act of2013. The bill's full title on GovTrack.us is listed as "To amend section 505of the Federal Food, Drug and Cosmetic Act to provide incentives for thedevelopment of new combination drugs." Chaffetz's bill was assigned to theEnergy 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 CosmeticAct should be amended to give new drug products five-year market exclusivity ifthey contain a combination of active ingredients that have not been approvedfor combined use previously. A spokeswoman for Chaffetz's office explained,"the legislation would give a new drug product—which contains a combination ofactive ingredients that have not previously been approved for use together—thesame period of market exclusivity—five years—as a drug product containing a newactive ingredient."

"While current law provides strong incentives to invest inR&D for combinations of entirely new combination drugs—composed ofbrand-new molecules—it provides much lesser incentives to invest in R&D forcombinations that include one or more previously approved drug molecules," thespokeswoman said in a statement to the FDA Law Blog. "On top of that, it is getting more and moredifficult and expensive to discover brand-new molecules.

"Additionally, the FDA requires applicants for newcombination drugs to demonstrate safety and efficacy in human clinical trials.The showing of efficacy must be against not only a placebo, but against each ofthe components separately. The process is both expensive and time-consuming andrequires considerable capital."

GovTrack.us gives the bill a 5-percent chance of gettingpast committee and a 1 -percent chance of being enacted, noting that "only 11percent of bills made it past committee and only about 3 percent were enactedin 2011-2013."