As the numbers of cases grow worldwide and the U.S. tops the list, it’s easy to wonder what the future cost of the Covid-19 novel coronavirus will be on the pharmaceutical industry. There are multiple companies rushing to push coronavirus cures, including one from Gilead Sciences that is already in phase 3 trials and will likely be completed by the time this article publishes.
Gilead’s stock price has gone up on the news, but what effect will this coronavirus have on the pharmaceutical industry?
The U.S. Food and Drug Administration (FDA) hasn’t been inspecting Chinese pharma manufacturing plants since February 14, 2020. This means that the active pharmaceutical ingredients (APIs) coming out of China aren’t being inspected and that’s going to exacerbate problems for an industry that’s already been rife with recalls. Of course, the FDA doesn’t rely solely on manufacturing plant inspections. The Agency released a statement saying:
Others tools include: import alerts, increased import sampling and screening, requesting records, in advance or in lieu of an inspection – firms may elect to provide this voluntarily to allow the FDA to make approval decisions, evaluation of previous FDA inspections history to determine if this information would suffice in lieu of an inspection, as well as relying on a firm’s previous compliance history and information from foreign governments with which we have mutual recognition agreements as part of our Agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements.
Here’s what pharma manufacturers are facing as future consequences of these changes.
The Cost of Doing Business
At the end of the day, the FDA is set up to protect consumers, and that’s what it’ll do. This coronavirus epidemic has consumers looking into medicines and viruses like never before. Never in our lives have we all been quarantined in our homes for over a month while the economy tanks and unemployment skyrockets to historic levels. While many economic analysts believe the economy will “rubber band” snap back to its original state, the long-term effects will materialize in the form of changed consumer opinions.
Consumer safety advocates will surely use this opportunity to push for further change. It has become obvious that our current supply chain is broken, and the U.S. relies heavily on products manufactured in a country in which it has very little control over the safety. This means it’s going to need to start putting heavy pressure on domestic drug manufacturers and producers using those active ingredients in their final products.
Recalls in the pharmaceutical industry could continue to grow over the next few years because of what’s happening right now. To give a general timeline, Gilead’s clinical trial approvals at the beginning of this month will lead to only 1 million covid-19 treatments being manufactured by December 2020. That’s over six months from now before a small portion of society can even take the sure-to-be-expensive treatment.
With one-year lead times or longer, consumers are currently taking drugs that were manufactured long before covid-19 hit. It’s only a matter of time before the effects of these changes start to materialize in the form of product recalls. Here’s how to protect yourself.
Automating the Recall Management Process
Product recalls are never easy. You need to notify customers, track information, and keep the FDA in the loop. It’s a daunting task that can easily put a company out of business if it attempts to handle this manually. Instead, Trievr Recall Management automates the process and can get you set up within minutes. All reporting, communications, and even customer questions are handled using our out-the-box solution.
Using this cloud-based SaaS program, you can reduce the costs of performing a recall and pay only for exactly what you need from our platform. Whether it’s 20,000 or 20 million, we can manage the entire process for one or multiple recalls at once. With this automated system, you’ll experience exponential savings that can keep your business running.
Contact Trievr today to learn how to get started with a recall management solution you can trust.