Last week, a major pharmaceutical company, Eisai Inc., sued the Drug Enforcement Administration (DEA), the very agency that stands between its FDA approved drug, Fycompa, and a commercial launch. Probably not the best way to win friends and influence others. So why was such a drastic step required?
As I engage with executives and board members in the Life Sciences industry, a common frustration is the sheer amount of regulations and red tape that slows progress and drives up costs. The majority of these executives understand and appreciate the role of regulatory agencies, yet all express a need to optimize the impact on their businesses. To some degree, executives walk a fine line about publicly complaining about the regulatory agencies that oversee them. A deeper look into the lawsuit reveals what might turn out to be the real underlying issue.
According to the suit, the FDA’s Assistant Secretary for Health (ASH) made 11 scheduling recommendations over the past several years to the DEA. All were considered for months, and all were ultimately assigned to the DEA schedule originally proposed by the ASH. For Lorcaserin, it took the DEA nearly a year to essentially take the ASH’s recommendation. There appears to be very little productivity improvement in many of the regulatory agencies and these examples from the DEA illustrate the point. Whether or not you believe in more or less regulation, most agree that every organization should seek to become more productive over time. Any commercial enterprise that doesn’t strive for continuous productivity improvements will become obsolete.
Why should it be any different for regulatory agencies? We need an appropriate check and balance for these entities. It may be inevitable that businesses will continue to face new and changing regulations but that is another debate. For now, companies have an expectation that these regulatory bodies are eliminating procedural and administrative waste to support their new laws. Unfortunately, thus far, they are disappointed at every turn.