By Michael D. I. Siget, JD, MPA, PAMED Legislative and Regulatory Counsel
Act 37 provides PA's secretary of health with authority to temporarily schedule substances for up to two years
On June 8, 2016, Governor Wolf signed into law Act 37, sponsored by Representative Matt Baker, chairperson of the House Health Committee. Modeled after a federal law, part of Act 37 provides unprecedented authority to the Pennsylvania Department of Health (DOH) to schedule substances on a temporary basis and quickly add substances in reaction to federal scheduling. In this edition of the Capitol Update Blog, we will take a look at DOH's new authority under Act 37, which takes effect on August 7, 2016.
The commonwealth's Controlled Substance, Drug, Device & Cosmetic Act (DD&C Act) provides the framework for the scheduling of substances into one of the five controlled substances list. Under the DD&C Act, every controlled substance is classified into one of five schedules based upon certain criteria such as its potential for abuse, its currently accepted medical use in treatments, and its risk to the public health.
Originally enacted in 1972, the DD&C Act was written at a time when new and potentially dangerous substances were not being created as quickly as they are now. As such, DOH has not been able to quickly react to new substances that are affecting the health and safety of the citizens of this commonwealth.
Currently, and until Act 37 takes effect on August 7, for a substance to become a schedule substance, and thus regulated by the Commonwealth, one of two procedures must occur. First, the General Assembly can enact legislation scheduling a substance (which will still be the case after Act 37 takes effect). As an example, this occurred in 2011 when the General Assembly enacted legislation scheduling certain synthetic cannabinoids.
Second, and by far the lengthier process, was for DOH to promulgate a regulation scheduling a substance. Under the commonwealth's Regulatory Review Act, state agencies can enact regulations after going through a lengthy process, which includes proposed regulations, public comments, Independent Regulatory Review Commission (IRRC) comments, stakeholder and public comments, fiscal reviews, and the like. While there is a legitimate purpose to this process, for situations like scheduling a substance, it has proven to be a slow process. The regulatory process can take anywhere from 12 to 24 months on average.
Due to the deliberate nature of the regulatory review process, it has been very difficult for DOH to promulgate regulations to effectively schedule substances that were affecting the health and safety of the Commonwealth. To add to this length of time, the DD&C Act currently also requires DOH to consult with the DD&C Board concerning whether a substance should be added. Further, DOH is not allowed to remove any substance from control unless specifically authorized by the General Assembly to do so nor could it reschedule any controlled substance unless specifically authorized by the DD&C Board to do so.
With the enactment of Act 37, the General Assembly recognized the growing nature of dangerous substances and the need for the Commonwealth to be able to quickly respond and thus it eliminated or reduced many of these provisions.
DOH now has the authority to reschedule any controlled substance to a different schedule if the federal government schedules that substance in a like manner.
As a hypothetical example, cocaine is currently a schedule II controlled substance under both federal and state law. If the federal government were to reschedule cocaine to a schedule I controlled substance, DOH would be able to do the same by merely publishing a notice in the Pennsylvania Bulletin. As stated above, under the soon-to-be old system, for this to happen, either the General Assembly would have to enact legislation or DOH would have to go through the lengthy regulatory process.
Under Act 37, if a controlled substance is rescheduled to a higher schedule (such as going from a schedule II to a schedule I), that cannot take effect for at least 30 days after publication of a notice in the Pennsylvania Bulletin. If, however, a controlled substance is rescheduled to a lower schedule (such as going from a schedule I to a schedule II), then that rescheduling can take effect immediately upon publication of a notice in the Pennsylvania Bulletin.
RECOGNITION OF OVER-THE-COUNTER DESIGNATION
Act 37 also authorizes DOH to exclude any substance or remove any control substance from the controlled substance list if that substance or controlled substance has been approved at the federal level for over-the-counter use. As with the recognition of federal scheduling detailed above, DOH can do so by publishing a notice in the Pennsylvania Bulletin.
By far the biggest impact of Act 37 is DOH's new authority to temporarily schedule a controlled substance in order to give DOH, or the General Assembly, time to permanently schedule that substance. To better explain this new authority, below is a list of the major steps in this process.
1. Finding of an imminent hazard to public safety: In order to temporarily schedule a substance, DOH must determine that the substance is an imminent hazard to public safety. In making that determination, DOH must determine whether the substance has a history and current pattern of abuse; the scope, duration, and significance of abuse; the risk there is to the public health; and whether the substance is controlled under federal law. However, if the substance is controlled at the federal level, DOH can disregard the other factors and schedule the substance based solely on the actions of the federal government.
2. Publication of notice in the Pennsylvania Bulletin of intent to schedule: To begin the process of temporarily scheduling a substance, DOH must publish a notice in the Pennsylvania Bulletin of its intention to temporarily schedule a substance and its reasons for such action.
3. Review by the Office of Attorney General: DOH must transmit notice to the Attorney General's Office for its review. The Attorney General's Office has up to 30 days to review DOH's notice and provide comments, if any, back to DOH. DOH must consider the A.G.'s comments in deciding whether to move forward with temporarily scheduling the substance.
4. Temporary scheduling: After reviewing the attorney general's comments and any other comments it has received, DOH must publish a notice in the Pennsylvania Bulletin that it is temporarily scheduling the substance.
A substance that is temporarily scheduled will remain scheduled for one year. However, DOH has the option, prior to the expiration of that one year, to temporarily schedule the substance for an additional year, for a total of two years. This provision was likely included to give DOH time to permanently schedule the substance as it would be inopportune for a substance to be removed due to the expiration of the temporary scheduling given the amount of time it may take to permanently schedule the substance.
5. Permanent Scheduling: Act 37 does not permit DOH to simply temporarily schedule a substance. If DOH has made the determination to schedule a substance on a temporary basis, it must move forward with the permanent scheduling of that substance or, in the alternative, ending the scheduling of that substance.
If, during the pendency of temporarily scheduling the substance DOH determines that the substance should no longer be scheduled, and the General Assembly has not enacted legislation permanently scheduling the substance, then DOH must publish a notice in the Pennsylvania Bulletin with its reasons for not proceeding with permanent scheduling. Upon publication of that notice in the Pennsylvania Bulletin, the substance will no longer be a scheduled substance. Any substance that is ultimately un-scheduled by DOH will not affect any civil or criminal proceeding that commenced while the substance was temporarily scheduled.
If, however, DOH proceeds with permanent scheduling, the General Assembly has provided for a quicker regulatory process. Instead of having to go through the entire regulatory process, DOH is authorized to proceed under what is known as "final-omit" regulations. Under this process, DOH may permanently schedule the substance without having to go through proposed regulations and the public comment period that follows. Instead, DOH can move straight to the final regulatory process. While this does not entirely eliminate public input or IRRC's role in the process, it significantly reduces the amount of time DOH will have to expend to permanently schedule the substance.
It is likely that the reason this was put in place was two-fold. First, DOH will have done its due diligence in researching whether to schedule the substance when it issued its temporarily scheduling notice. This process will have included input from the Attorney General's Office, which is part of the normal regulatory process.
Second, the General Assembly recognized that if a substance is so hazardous to the public that DOH needed to move quickly to schedule it, then it would be counterproductive to then require DOH to go through the lengthy regulatory process and risk having the temporary scheduling of that substance expire prior to the normal regulatory process having been completed. While DOH will still be required to go through the regulatory process, that process will be expedited.
Once the final-omit process has been completed, the substance will no longer be temporarily scheduled but will instead be permanently scheduled.
6. Judicial Review: Like its counterpart under federal law, temporary and final scheduling under Act 37 is not subject to judicial review. It is likely the General Assembly recognized if someone could bring an action in court to halt DOH's scheduling of a substance under Act 37, then that would defeat the purpose of scheduling a substance quickly due to its hazardous nature. Instead, those persons wishing to object to DOH's actions may do so through the regulatory process outlined in Act 37.
It will be interesting to see when and under what circumstances DOH chooses to use its new authority. DOH will need to balance the need to protect the public from new dangers while at the same time not go overboard and begin scheduling too many substances that upon further review are not really appropriate for scheduling under Act 37.
By not using Act 37 enough, DOH could put the public at risk. By using Act 37 too much, DOH could risk concerns by the General Assembly that its reasons for enacting Act 37 are being stretched beyond what the General Assembly intended.
In addition, while Act 37 provides a quicker process for scheduling substances, it is by no means as quick as Act 37 reads on paper. Prior to publishing its intent to temporarily schedule a substance, DOH will need to have its research done in order to justify why it has chosen to schedule a substance.
If the federal government's process is any indication of how DOH will proceed with temporary scheduling, it will take some time for DOH to have its research done.