Congress Presses DEA to Open up on Regulatory 'Black Hole'

| 17 June 2013 | By Alexander Gaffney, RAC, 

Once, professionals engaged in pharmaceutical regulatory affairs had only one agency to worry about: the US Food and Drug Administration (FDA), which has principal authority over whether a drug is safe and effective for use. But in recent years the US Drug Enforcement Agency (DEA) has begun to flex its influence on the approval of some products with the potential for abuse, and now members of Congress are taking notice, demanding answers about the lack of transparency in DEA's scheduling process.

Background

While FDA determines if a drug is safe or effective, DEA is charged with determining a drug's potential for abuse and how it should be regulated under the Controlled Substances Act of 1976. The law contains a number of possible restrictions, including an outright ban on Class I substances for which the substance has no recognized medicinal benefit. For Classes V through II, which have recognized medical benefits, DEA places increasing burdens on products depending on their potential for addiction or abuse.

For example, opiates are generally regarded as Class II drugs with a high potential for abuse, and DEA regulates the supply and sale of the drugs' active pharmaceutical ingredient, prescribing habits (e.g. no refills on prescriptions), and who can dispense the drug (e.g. licensed practitioners).

The problem, however, lies not so much with DEA's authority to regulate, but rather the process by which it regulates, which many have complained is slow, opaque, and deprives patients of access to new therapies.

Case Study in Delays: Belviq

The case study for these delays may well be the case of Arena Pharmaceuticals' Belviq (lorcaserin), a weight loss drug approved by FDA in June 2012 - the first weight loss drug approved by FDA in more than a decade, in fact. But despite the drug's potential to be first to market, the drug entered a 10-month long quagmire at DEA undergoing the scheduling process, only to emerge as a Class IV controlled substance.

Schedule IV substances meet three criteria: The drug has a low potential for abuse, has a clear medical use, and abuse of the drug has relatively minor adverse health effects. DEA noted the drug's "central nervous system hallucinogenic properties," meeting the first and third of those criteria.

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.

Comments submitted to the Federal Register in advance of DEA's scheduling announcement mirrored Coats' comment, noting that given the health effects associated with obesity, a 10-month delay was unacceptable, particularly after FDA had already demanded huge amounts of clinical data and commitments to conduct six postmarketing studies to assess the drug's health risks.

Congress: From 'Black Box' to Sunshine

And now members of Congress are mirroring those concerns, writing to DEA demanding more information on DEA's scheduling process. The 11 June 2013 letter, signed by six Republican members of the House Energy and Commerce Committee, notes that Congress just signed the FDA Safety and Innovation Act (FDASIA) in 2013, which they noted was meant to "improve the predictability, consistency and transparency of FDA's prescription drug review process."

The congressmen went on to note that DEA's scheduling process, albeit an "important part in the review of prescription drugs containing controlled substances," 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.

The letter goes on the request four pieces of information from DEA:

• The number of FDA-approved substances reviewed each year since 2007 and the time spent to review each product.
• Instances of DEA deviating from FDA's scheduling recommendation
• The average time spent to schedule a drug since 2007, and whether this has increased or decreased over time.
• Common reasons for delaying a final scheduling decision for a drug, and what steps or discussions are taken to address outstanding questions with the sponsor.

DEA has until 26 June 2013 to reply, per the letter's request.

Letter to DEA