Everyone agrees patients are waiting far too long to access new drugs and treatments that enhance and extend lives. Most people concerned with accelerating treatments and cures are understandably focused on the process of drug discovery, development and approval. However, a less known but equally frustrating impediment is a federally required “scheduling” under the Controlled Substances Act (CSA). The process can delay patient access to some new drugs a year or more beyond FDA approval. For the field of neurosciences, where the drug pipeline is already thin, this added potential delay factored into business decisions can deter R&D investment into this already risky disease area where truly novel drugs are sorely needed.
Under the CSA, drugs deemed as having any abuse potential must undergo an FDA liability analysis of eight factors. Unlike the drug’s initial review process, there are no specific performance goals for timeliness. After the FDA completes its analysis, the agency’s recommendation is sent to the Assistant Secretary for Health at HHS for a final secondary review.
Then, the Drug Enforcement Agency (DEA) does its own, repeated eight-factor analysis that eventually leads notice-and-comment rulemaking (which itself is a lengthy process). DEA is also under no obligation to complete its analysis and rule-making in any particular timeframe, yet until it does so, a new “approved” drug cannot be made available to patients. Despite this added time and duplicative process, the DEA has not overridden an FDA recommendation in more than 15 years.
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This delay primarily affects truly “novel” drugs, the breakthrough drugs arguably most important to patients. Drugs in existing classes (such as opiate pain medications) or clearly related to existing medicines do not face the same delays, because they are automatically scheduled for the abuse liability review.
Legislation recently introduced by Reps. Joe Pitts and Frank Pallone, HR4299, is a common-sense attempt to provide a legislative solution to the very real and vexing current state of drug scheduling, while preserving the DEA’s proper role and authority. The bill would require the DEA to issue an interim final rule within 45-days of receiving the HHS recommendation for novel therapies only.
This change recognizes that current law requires DEA to defer to FDA on scientific and medical matters, since a truly novel drug would have no marketing history in the United States (and a very unlikely possibility of any substantial experience outside the US, given that the US is the first agency to approve the majority of truly novel drugs). The factors that are clearly under DEA’s area of expertise remain subject to the agency’s analysis and determination. Because the legislation proposes that DEA issue an interim final rule, DEA would be still be responsible for completing a final rule, which would allow for DEA to further refine or change the determination.
The primary benefit of this interim final rule provision is to allow marketing and education among providers and practitioners who serve patients while DEA completes its own evaluation and finalizes the rulemaking.
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As neurologist Nathan Fountain, chair of the Epilepsy Foundation professional advisory board made clear in a recent op-ed, lives are at stake. Fountain used the example of an antiseizure medication approved by FDA on October 22, 2012 and scheduled and approved for marketing by DEA on January 2, 2014 – an astounding 14 months later. Patients, families, parents, and their physicians should not have to needlessly wait for one federal agency to sign off on the work of another when the process provides no added health and safety benefits.
Given the public impetus to speed the availability of innovative therapies to patients, it is hard to understand why someone would object to this common sense solution developed by the chairman and ranking member of the House subcommittee on health.
