Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 27 March 2014 | By Alexander Gaffney, RAC,
A new piece of legislation introduced today by a bipartisan congressional duo calls for the improvement of a current regulatory stumbling block that some companies have likened to a "black hole."
While the US Food and Drug Administration (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 the US Drug Enforcement Administration (DEA) and the Controlled Substances Act (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.
But because the drug had "central nervous system hallucinogenic properties," the US Department of Health and Human Services (DHHS) recommended that the drug be placed into Schedule IV of the CSA-the second least-restrictive category available.
But 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.
Those struggles have prompted congressional interest in the DEA scheduling process, especially relative to drugs just approved by FDA. In June 2013, six legislators wrote to DEA demanding answers about the lack of apparent transparency in DEA's scheduling process.
While conceding that the process is an "important part in the review of prescription drugs containing controlled substances," the legislators noted that scheduling can take longer than six months to complete.
"Such a delay in the review process means a lag in patient access to innovative treatments," they wrote, pressing DEA for details about its approval record.
Now one of the co-signers of that letter and the chairman of the House committee that oversees FDA, Rep. Joe Pitts (R-PA), has joined with Rep. Frank Pallone (D-NJ) to introduce legislation that would overhaul the process by which DEA schedules new drugs.
The legislation, the Improving Regulatory Transparency for New Medical Therapies Act, would require DEA to schedule a drug on an interim basis within 45 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 (at least in the interim).
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.
"This bill will help further the innovation already occurring throughout the medical community and continues our committee's important bipartisan efforts to improve the drug approval framework," Pallone said.
Pitts, Pallone Statement
Tags: Scheduling, Controlled Substances Act, CSA, Legislation, House, DEA, Latest News, Bill, pharmaceutical, drug
Regulatory Focus newsletters
All the biggest regulatory news and happenings.