Under Control: Some Controlled Substances May Have a Later Exclusivity Start Date With the Enactment of a New Law

By Kurt R. Karst

Last Wednesday, November 25, 2015, after a long slog through the legislative process (see our previous post here), President Obama signed into law the Improving Regulatory Transparency for New Medical Therapies Act (H.R.639). (Unlike other bills, H.R.639 doesn’t have a sexy acronym, so we’ll just refer to it as “the Act.” “IRTNMTA” – the Improving Regulatory Transparency for New Medical Therapies Act – rolls off the tongue about as easily as “FLDSMDFR” – the “Flint Lockwood Diatonic Super Mutating Dynamic Food Replicator” – for those of you with children or who are fans of the movie “Cloudy with a Chance of Meatballs.” And here’s the obligatory You Tube clip explaining the FLDSMDFR.)

The Act amends the FDC Act to add Sections 505(x) (human drugs) and 512(q) (animal drugs), and the PHS Act to add Section 351(n) – in each case titled “Date of approval in the case of recommended controls under the CSA” (where “CSA” is the Controlled Substances Act) – to provide, in general, that:

with respect to a [human or animal] drug [or biological product] for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the [CSA], approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with [CSA §201(j)].

Specifcally, the Act provides that the “date of approval” of an NDA, NADA, or Section 351(a) BLA for a controlled substance awaiting a scheduling determination by the DEA is the the later of the date of NDA, NADA, or Section 351(a) BLA approval, or “the date of issuance of the interim final rule controlling the drug.” A similar change is made to the Patent Term Extension (“PTE”) statute at 35 U.S.C. §156(d)(1) to provide that the 60-day deadline for filing a PTE application with the PTO for a patent on a covered drug subject to CSA scheduling is the later of application approval or “the date of issuance of the interim final rule controlling the drug under [CSA §201(j)].” (There are some additional provisions under the Act applicable to animal drugs for minor use and minor species – FDC Act §571 – and to marketed unapproved new animal drugs for minor species – FDC Act §572 – but we won’t get into those provisions here.) Further, the Act amends the CSA to add Section 201(j) concerning issuance of an interim final rule scheduling a drug under the CSA. (The Act also makes other changes to the CSA concerning enhancing new drug development and re-exportation among members of the European Economic Area.)

Putting aside for a moment all of the legal citation and what not, what’s the bottom line of the Act? Well, as explained in so many words in the House Report accompanying the Act, the Act would remedy an unfairness created by bureaucratic red tape. Drug products containing controlled substances can be approved, but, until the enactment of the Act, were unable to be marketed until the DEA issued a final determination scheduling the controlled substance under the CSA (and appropriate labeling changes were made reflecting the scheduling determination). In some relatively recent instances, that has meant that a company has been unable to market its drug product after FDA approval – sometimes for more than a year – while the 5-year period of New Chemical Entity (“NCE”) exclusivity has ticked away. By resetting the date of approval of a drug product containing a controlled substance requiring scheduling to be the later of the date of application approval or the date of issuance of the interim final rule scheduling drug, a company will not be punished by a scheduling delay.

Eisai Inc. (“Eisai”) led the charge to change the law. The company initially sued DEA to force the issuance of a Notice of Proposed Rulemaking to schedule FYCOMPA (perampanel) Tablets (NDA 202834) (see our previous post here), and petitioned FDA alleging that the Agency erroneously triggered the 5-year NCE exclusivity periods for FYCOMPA and BELVIQ (lorcaserin HCl) Tablets (NDA 022529) before the drugs were scheduled by the DEA under the CSA (see our previous post here). After FDA denied Eisai’s Citizen Petition (Docket No. FDA-2013-P-0884), the company sued FDA (see our previous post here). In September 2015, the U.S. District Court for the District of Columbia granted FDA’s Motion for Summary Judgment and denied Eisai's Motion for Summary Judgment. Judge Randolph D. Moss concluded that despite some good arguments put forth by Eisai, FDA’s interpretation of the Agency’s own controlling regulation defining the term “date of approval” is not plainly erroneous or inconsistent with that regulation (see our previous post here).

While the Act clearly applies to future instances in which DEA delays cut into a company’s period of NCE exclusivity, it’s unclear to us whether or not the Act will have any retroactive effect to apply to cases such as FYCOMPA and BELVIQ. The Act does not include an “effective date” provision, perhaps leaving open the door for some argument for retroactive effect. This is not a new debate in the context of newly enacted legialtion. As former FDA Chief Counsel Daniel E. Troy noted in his treatise on retroactive legislation, “[t]he problem of defining when laws are and are not retroactive, and when they should and should not be permitted, is of ancient origin.”