CSA Legislation Reintroduced to Speed Up DEA’s Scheduling of New Medicines and Approval of DEA Manufacturer Registrations in Certain Circumstances; Define “Imminent Danger”; and Change the Game for Orders to Show CauseJanuary 29, 2015
By Karla L. Palmer –
A very busy House Energy and Commerce’s Subcommittee on Health (chaired by Joe Pitts (R-PA)) held a hearing earlier this week to review six bi-partisan bills intended to benefit veterans, address the prescription drug abuse crisis, secure access to medical care, and improve certain provisions of the Controlled Substances Act. Several witnesses testified in support of the bills. A link to the bill summaries, witness list and testimony is available here. Two of the bills should seem familiar and of particular interest to those following DEA matters.
The first, H.R. 4299, titled “Improving Regulatory Transparency for New Medical Therapies Act,” was first introduced in March 2014 (see our previous post here). The current version would amend 21 U.S.C. § 811(a); specifically, any request by the Secretary of HHS to control a drug or substance not previously scheduled, “shall be commenced not less than 120 days after receipt of written recommendations by the Secretary.” The bill continues, “the final rule [scheduling the drug] shall be issued not later than 60 days after the date on which both the public comment period has closed and the substance is the subject of an approved new drug application.” Recall that DEA’s delay in scheduling new drugs made headlines (as reported here and here), when Eisai (maker of seizure treatment medication FYCOMPA) sued DEA after a delay in excess of a year in scheduling FYCOMPA. Eisai later sued FDA over a related issue involving the start of new chemical entity exclusivity (see our previous poet here). Dr. Nathan Fountain, on behalf of the Epilepsy Foundation of America, yesterday testified that DEA’s scheduling of new molecular entities lacks transparency and timeliness. He noted that the time period between drug approval and scheduling has increased over the years almost five times (from an average of 49.3 days to an average of 237.6 days). Dr. Fountain urged that passage of the bill would permit innovative treatments to reach the market and provide a clear timeline for availability.
Seeking to ensure timely manufacturing of study drugs, H.R. 4299 would permit drug manufacturers to more quickly obtain a DEA registration when using controlled substances in only clinical trials. The DEA would be required – in accordance with to-be-enacted regulations — to grant a manufacturer registration or serve an order to show cause on the applicant not later than 180 days after receipt of an application (and all other information the Attorney General deems necessary to make a determination). One question remaining is what exactly is “all other information the Attorney General deems necessary to make a determination,” and, whether a claim that DEA has not received such information — whatever that information may be — could significantly delay the circumvent the 180-day deadline.
The second DEA-related bill addresses the definition of “imminent danger” in the context of immediate suspension orders, and would provide for greater oversight of DEA’s activities. Note that Immediate Suspension Orders permit DEA to bypass the typical Show Cause process and suspend a DEA registration without notice or a hearing. H.R. 471, titled “Ensuring Patient Access and Effective Drug Enforcement Act of 2015,” is purportedly based on former H.R. 4079, which passed the House last year. The new bill is similar to S. 2862 (see our previous post here).
New H.R. 471 would modify the definition of “imminent danger to the public health and safety” to mean that, “in the absence of an immediate suspension order, controlled substances: (1) will continue to be intentionally distributed or dispensed (a) outside the usual course of professional practice or (b) in a manner that poses a present or foreseeable risk of serious adverse health consequences or death; or, (2) will continue to be intentionally diverted outside of legitimate distribution channels.
S. 2862 differs from from H.R. 471 in at least two material respects: First, it tied imminent danger to dispensing and distribution by a registrant “who knows or should have known through fulfilling the obligations of the registrant under the Act, or has reason to believe that” dispensing is outside the usual course of professional practice….” In other words, the suspension would be tied to the registrant with knowledge of the wrongful activity.
Second, the new bill does not seem to tie “imminent danger” to a “registrant’s” knowledge. And, it defines “imminent danger” as those situations when controlled substances will “intentionally be distributed or dispensed …” or will “continue to be intentionally diverted outside legitimate distribution channels.” The bill is unclear about whose “intent” counts for the purpose of the “imminent danger” determination – is it a registrant, a downstream user, an upstream supplier?
Like proposed legislation introduced last year (see our previous post here), the bill also proposes to amend 21 U.S.C. § 824 to provide a registrant facing revocation or suspension of a DEA registration the opportunity to submit a corrective action plan within 30 days after receipt of an order to show cause. The new provision would require DEA to review a corrective action plan to determine whether to dissolve, modify or continue with show cause. The bill states that the corrective action provisions do not apply to immediate suspension orders.
Lastly, the bill contains reporting requirements concerning the effect of DEA enforcement activities on patient access to controlled substances and diversion. The report must be prepared in consultation with patient groups, pharmacies, manufactures and other entities throughout the pharmaceutical manufacturing and distribution chain.