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Regulatory News | 22 September 2014 | By Alexander Gaffney, RAC
For most pharmaceutical products in the US, obtaining approval from the US Food and Drug Administration (FDA) to market a product means a company can begin selling its product as soon as it wants. But for a subset of products subject to the Controlled Substances Act (CSA), the Drug Enforcement Administration (DEA)—not FDA—is the ultimate arbiter of when market access occurs and the extent to which it occurs.
Now new legislation wants to make the process by which DEA subjects new pharmaceutical products to the CSA scheduling process more predictable and less onerous.
While FDA determines whether a drug is safe and effective in the US, the determination of whether its component parts are addictive or prone to abuse falls under the authority of DEA and the CSA.
The CSA is the statutory backbone under which drugs with the potential for abuse or misuse are regulated, and contains a progressive range of classifications ranging from Schedule I (most addictive/least medically useful) to Schedule V (medically useful with a low potential for abuse).
But for drugs required to undergo DEA's assessment process, the agency's regulatory review can make FDA's look prompt in comparison.
Take for example the case of Arena Pharmaceuticals' Belviq (Lorcaserin), a weight-loss drug approved by FDA in June 2012. At the time of its approval, it was the first weight-loss drug to be approved by FDA in more than 13 years, and was heralded as a potential breakthrough approval for patients with obesity.
Because the drug had "central nervous system hallucinogenic properties," the US Department of Health and Human Services (DHHS) recommended that it be placed into Schedule IV of the CSA—the second least-restrictive category available.
Despite DHHS' recommendation, the Belviq decision was left to stagnate for the better part of a year. In an interview in The Pink Sheet Daily in April 2013, Eisai CEO Lonnel Coats, whose company is also involved in the marketing of Belviq, said the DEA scheduling process amounted to a "black hole."
"We have very little insight into that hole," Coats added. That process, he explained, stands in opposition to that of the US Food and Drug Administration, which he said had more favorable levels of transparency in the form of timelines and set expectations.
DEA finally approved the drug's Schedule IV status in May 2013—nearly a year after Belviq was first approved.
While Belviq may be the case study for lengthy DEA assessments, it's hardly the only product subject to delays. For some products, such as Merck's insomnia drug Belsomra (suvorexant), a longer-than-expected FDA review process actually worked in its favor, as DEA managed to clear the product as a Schedule IV substance just weeks after FDA approved the drug.
Editor's note: A previous iteration of this article claimed that Orexigen Therapeutics' drug, Contrave, was still awaiting DEA scheduling. The drug does not contain controlled substances, and is therefore not subject to DEA's scheduling process. We regret the error.
These challenges have not gone unnoticed by legislators, who have introduced several pieces of legislation to accelerate the DEA scheduling process for new drugs in the last two years.
The first of these pieces of legislation, co-sponsored by Reps. Joe Pitts (R-PA) and Frank Pallone (D-NJ), was the Improving Regulatory Transparency for New Medical Therapies Act, which would require DEA to schedule a drug within 180 days of receiving a recommendation from FDA.
The requirement would only apply to drugs which have never before been marketed in the US, but would require DEA to schedule the drug in accordance to FDA's recommendation.
The bill also aims to assist in the development of new drugs by focusing in part on clinical trials. The law makes it easier for manufacturers and distributors of controlled substances to indicate that their stock will only be used "in connection with clinical trials of a drug" seeking approval from FDA. In such cases, DEA would have 180 days to complete the registration—needed before a controlled substance can be manufactured or distributed—of a trial sponsor.
The legislation followed months of legislators pressuring DEA to offer more information about its scheduling process. DEA's scheduling delays are resulting in "a lag in patient access to innovative treatments," six Republican legislators wrote in a letter to DEA in June 2013.
Now the Senate is picking up where the House left off. On 18 September 2014, Sens. Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI) introduced the Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act in the US Senate.
Like the House version of the DEA legislation, Hatch and Whitehouse's bill would create DEA scheduling deadlines. After receiving a recommendation from FDA, DEA will have 45 days to scheduling a drug on an interim basis. The legislation also mirrors the House version's efforts to make it easier to distribute controlled substances as part of a clinical trial, requiring DEA to register an applicant within 180 days.
In addition, companies would also be given the opportunity to submit corrective action plans if they are subject to a suspension of their registration. FDA is also tasked by the legislation to work with DEA and other federal agencies to determine what obstacles exist to "legitimate patient access to controlled substances" as well as "issues with diversion of controlled substances."
Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act
Tags: DEA, Drug Enforcement Administration, Scheduling, Legislation, Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act, Improving Regulatory Transparency for New Medical Therapies Act