Why Regulatory Intelligence is No Longer an Option for the Life Sciences Industry
By: V. “Bala” Balasubramanian, Ph.D., MBA, SVP – Pharma & Life Sciences
Throughout the course of my day-to-day activities, I often find myself sympathizing with my clients’ tales of near misses and frustrations — and their endless chase for timely, accurate regulatory intelligence. Within almost all of their narratives, I’ve noticed a recurring theme: fast changing regulations across the globe present greater challenges to Life Sciences companies and negatively impact how fast these companies can bring drugs to market.
The need to keep up with regulatory intelligence is vital for Life Sciences companies, with information moving across the policy, strategic and submission levels of each given organization. In an attempt to keep up with ever-changing regulations, companies struggle with spreadsheets, multiple SharePoint sites and home-grown databases, resulting in delayed or missed filings and ultimately lost revenues.
The keepers and consumers of Regulatory Intelligence are stretched to the point of exhaustion and hopelessness. Below is a sampling of their stories.
When Stalled Processes Lead to Missed Revenue
A large pharmaceutical company had plans to file a New Drug Application (NDA) for one of its major products in an East Asian country when there was a change in local regulatory personnel. After being introduced to the new personnel, the product team was informed that “race/ethnic equivalency studies” were important in reviewing the drug application before the local health authority could start the approval process. Though clinical trial data was available for patients in China and Japan, it failed to meet the regulatory requirements of the country where the NDA was to be filed. The company was then forced to postpone and redo the filing and resulted in missed market revenues. To blame for the stalled process: inaccurate, unattainable intelligence.
When a Downstream Bottleneck Results in Unsalvageable Product
After modifying safety regulations and ordering that a specific ingredient be removed from all industry formulas, a health authority gave all cough syrup companies a two-year notice to comply with the policy change. Unfortunately, however, for one manufacturer whose cough syrup contained the ingredient, this requirement was not adequately tracked. The company had previously missed a policy level change by the health authority that the ingredient be removed, and the announcement did not make it to the operational level. As a result, large batches from their product inventory were unusable and destroyed and the company then had to withdraw products from the shelf. To blame for the missed intelligence: an inadequate cascade of intelligence downstream.
When an Upstream Bottleneck Ends with NDA Rejection
While filing for an NDA that required a Certificate of Pharmaceutical Product (CPP) from a secondary market, an organization sought to establish approval for its product in the major market exporting the drug. The secondary market’s prevailing definition of the CPP included confusing, convoluted regulatory changes that led to a bottleneck at the local level. Without any quality intelligence, these changes didn’t make it upstream, thus ending with a rejection of the NDA. To blame for the rejected drug: bad intelligence.
When Relying on Employee Knowledge Results in Refusal to File
Another company’s stock dropped 90% in one day after an entire filing got rejected with a “Refusal to File” notice. The regulatory contact who was previously communicating with the health authority had agreed to meet some necessary requirements. Once the employee left the company, however, the company was helpless as the communications were embedded in encrypted email threads, which no one else was aware of. The company filed for the product without addressing the requirements so the health authority rejected the filing due to non-compliance. To blame for the rejected filing: bad management of intelligence.
These scenarios are all based on true stories. When I began writing this blog post as a cautionary tale for others to heed, more and more stories flew into my mind. Keep in mind that these stories are not rare; as the words take form, you’ll realize that the characters and situations from one organization to the next are not all that different. The stories could be identical; in highly regulated industries, tracking global changes in regulatory intelligence is an uphill battle.
So what did we learn? These stories function as a call to action: we need to change how regulatory intelligence is managed, and we need to do it now. I encourage you to draw parallels between these stories and the ones you’ve endured but let’s not wait for any sequels. Let’s act now on fixing the process and capabilities for managing regulatory intelligence.
V. “Bala” Balasubramanian, Ph.D., MBA
SVP – Pharma & Life SciencesBala heads the Pharma & Life Sciences Business Unit at Orion. Prior to Orion, Bala was President and CEO of Cabeus, responsible for providing the company vision and strategy to be a niche products and services firm for Life Sciences. He was responsible for the vision and direction for a SaaS platform called ReALM® to transform the regulatory value chain within Life Sciences.
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