Drug approvals are often complex and time-consuming, even for generic versions of approved medications. Some of this complexity is unavoidable for good reasons, especially when it comes to patient safety. Much of the process is specifically designed to minimize the chance that new drugs – or new versions of existing ones – will cause harm.
Shortages of prescription drugs are also an ongoing concern worldwide. There are various initiatives that have been crafted to combat the problem. For example, the FDA gives special consideration and priority to abbreviated new drug application (ANDA) prior approval supplements (PAS) which address drug shortages or disasters. But the timelines are still lengthy – in some cases up to 10 months – diminishing its value as a rapid solution to drug scarcity.
In addition, there is an overabundance of “red tape,” regulatory hurdles, and bureaucratic mazes. How efficiently you’re able to navigate these challenges can have a significant impact on how quickly your product can go to market — or even get to the market at all.
Expert knowledge of how the many different pieces of this system work is a competitive advantage even in the best of times. In the era of COVID-19 — with personnel, raw materials, and supply chains being pushed to the limit — it’s critical. As one might expect, success depends not just on what you know, but who you know.
Overcoming the Obstacles with Regulatory Expertise
Here’s an example of how these two factors can work together to drive significant results. LGM recently had an approved ANDA in our name. Unfortunately, the API used in the process was no longer available. As a result, the product was at risk of being discontinued.
Established relationships played a significant role in overcoming this challenge at several stages of the process. First and foremost, the API needed to be validated with a different company. Fortunately, we have access to a portfolio of more than 2,000 APIs from a robust global network of qualified manufacturers.
With its extensive background in handling all aspects of FDA clearance, our team also knew that it wouldn’t be necessary to go to the time and expense of filing a completely new ANDA. Instead, they filed a Prior Approval Supplement (PAS) to the existing ANDA. In this way, the FDA needed only to approve the update to the API validation, allowing us to avoid unnecessary steps.
Leveraging Market Forces and Relationships
Thanks to the efforts of the FDA and other groups, the number of new drug shortages in the US has declined significantly in the last decade. While the trend was still downward in 2017 and 2018, two major drug manufacturing facilities were closed for remediation during the same period.
This loss of capacity needed for the supplies of a wide variety of drug products resulted in an ongoing impact on production. Signs of strain were already evident in 2019, when supply shortfalls began to tick up again. That year saw 166 new shortages, with more than 260 active shortages in any given quarter.
All that was before COVID-19.
In the first quarter of 2020 alone, there were more than 270 active shortages. As the pandemic spread, some existing shortages became more serious while other new shortages were created. Today, roughly half of all drugs in shortage are injectables – including analgesics, sedatives and paralytics used for intubating critically ill patients.
Thankfully, the product mentioned above offered some relief to these challenges. A key factor in this product’s favor was market demand. In this case, the need for the product was so strong that the drug in question was on the FDA shortages list.
LGM had developed a functionally successful relationship with the FDA’s Office of Drug Shortages. This relationship allowed us to correspond with the FDA on a regular basis. We received approval for the product’s PAS in about two months.
To put that in perspective, the FDA typically tries to respond to a PAS in six months if it doesn’t require a facility inspection, or ten months if it does. The combination of LGM’s regulatory expertise and well-established relationship with the FDA were crucial to beating the average and getting the review process completed in record time.
Choosing a partner with deep regulatory expertise and solid relationships with regulatory bodies can help expedite your product along the approval pathway.
Related LGM Pharma Services
Commercial Stage cGMP APIs
Regulatory Support Services
Contact LGM Pharma