The pharmaceutical industry, like many business sectors, generates tons of money. Its C-level leaders thrive on competition and profit, constantly striving to get the next big drug or pushing to get into the next major market first. And for US-based pharma companies, there’s an even larger expectation to “win, win, win” in the global marketplace—to drive the “American dream,” so to speak, to its full potential.
With so much pressure, it’s no wonder harmonization efforts seem to be plagued by roadblocks. Sure, expert working groups and ICH reps continue to meet and put forward new or revised guidelines. But how “on board” are the regulatory bodies themselves? You know, the people actually responsible for implementing the harmonization guidelines once they come to fruition?
Take for example the Common Technical Document (CTD), signed off by the three ICH bodies (FDA, EU, and MLHW) eight years ago. The format is now standard for companies worldwide, but each region (and in some cases, each country) has individual supplements, annexes, etc. that have to be submitted with the CTD. So while the format is harmonized, the data or “meat” of the document is not, as pointed out by Baxter’s Kelly Davis at Interphex last week.
If the pharmaceutical industry and its regional regulatory partners truly want to harmonize, then there can’t be individual requirements. That only defeats the purpose of “harmonizing” efforts.
I used to work for an organization tied to the United Nations, so I understand how hard it is to bring people of different backgrounds and with different goals together to agree on one document or standard. But it is possible if people are willing to compromise. One major difference between UN delegates and Pharma reps of course is that revenue and competition play a much larger role in decision-making for the latter group. But at the end of the day, whether we’re talking about ending conflict or manufacturing anti-malaria drugs, safety should be on everyone’s mind. So with that in mind, is the pharma sector willing, or able, to compromise?