I thought I’d share with you a few things that we believe will impact us immensely. They impact us because they impact you.
1. FDA inspections are undergoing a massive change.
In 2015, approximately 60% of inspections will happen overseas, and this trend will likely continue. Over time, I’d expect the FDA to eventually balance inspections based on the location of manufacturers in the supply chain.
I think industry is also wondering about inspector experience levels. The FDA has hired a ton of new inspectors over the last 5 years, and so a lot of companies are seeing green inspectors – sometimes even as the lead. Can the veterans equip the rookies, in a time of increased complexity, culture, and language barriers? Companies would be well-advised to have deeper inspector intelligence – get a sense for their inspection history, 483 issue rate, specific areas of focus, and whether any of their inspections resulted in warning letters. This is partly why we are developing more comprehensive InspectorRank profiles (more on that soon).
2. The Pharma industry will keep on consolidating.
No surprise here. These massive networks of manufacturing capacity will need to be managed and optimized. The ebb and flow of drugs getting approved, drugs coming off patents, and creative manufacturing partnerships is tricky – companies that can plan flexible manufacturing capacity will be more efficient and save a lot of money.
For GMP regulatory intelligence, many of these merged companies will need to develop or acquire new areas of expertise – bio, drug, API, and combination products. Some regulatory intelligence groups will have to recruit external experts or leverage tools to get up the learning curve quickly.
3. Some facilities based in India and China will catch up quickly, some will continue to fail miserably.
These facilities have been all over the news, but don’t be fooled. Not all of them are created equal – some will continue in their inept ways of cover-ups and incompetence, while others are learning from their counterpart’s mistakes. I can’t tell you how many customers we get – particularly in the last 6 months – that are from India and China. Some are asking the right questions.
Imagine if they had an active program in 2005, and they knew what the FDA and EMA were looking into (data integrity has been cited at companies for more than 10 years!) – think about the hundreds of millions of dollars damage that could have been avoided. The first major warning letters were issued to Indian manufacturers in 2008. 7 full years later, many of the issues have only multiplied. The next 3 years will reward the winners and punish the losers badly.
4. Internal GMP Regulatory/Quality resources/budgets are shrinking.
Anecdotally, I’ve heard that many companies are not rebuilding their internal teams. When someone leaves, the position is essentially eliminated. Jobs are combined or less experienced staff fill positions. Of course, when a warning letter is issued, money is thrown around to “address the problem.”
Imagine your manufacturing facilities are a boat. Some companies “address the problem” by actually fixing the broken boat; at other companies, “address the problem” is merely buying the team new buckets to keep bailing out the same old broken boat. The smarter companies are dealing with this problem at its root – by improving intelligence systems and processes and ensuring that their intelligence “data” is quickly converted to actionable “knowledge.”
One thing we will try to do this year is to help you make your case to management. We’ll equip you with data so you can make the case of how dangerous a broken boat is – to your company and ultimately, to patients. I believe that this is a perfect time for teams to identify time-saving, robust, data-driven tools and services. Do more with less. By leveraging tools and expertise, your team can actually work on the value-added analysis, decision-making, and remediation.
So, what did I miss? Do you see other trends for your business that could change your job dramatically?