Blog | March 27, 2015

FDA, EMA Drug Approval Stats: Are We Measuring Success The Wrong Way?

By Anna Rose Welch, Editorial & Community Director, Advancing RNA


Last spring, a report by the Centre for Innovation and Regulatory Science (CIRS) highlighted the number of new drug approvals and approval times for New Molecular Entities (NMEs) being reviewed in the U.S., the EU, and Japan. According to  Regulatory Affairs Professionals Society (RAPS), the EU boasted a higher number of drug approvals than the FDA in 2013 (38 NMEs vs. 27 in the U.S.). However, the FDA was quick to emphasize that, while it took Europe a median 478 days to approve a drug, the FDA’s median approval time was only 304 days in 2013.

It’s no secret the pharma industry thrives on competition, and clearly, the regulatory agencies do as well. I’m sure approval stats such as these serve the purpose of inspiring agencies to surpass their previous approval records, as well as that of their competitors (and give them something to brag about when they do). In fact, the FDA just released new stats this week showing it’s already approved 10 new drugs in 2015, suggesting the agency is well on its way to a promising 2015 approval record.

But while these stats spark declarations of excitement from each regulatory agency and make news headlines, the differences in approval times in particular aren’t necessarily a cause for celebration; rather, they illuminate something much more concerning about the state of global drug development.

Just last week, Sanofi’s Head of R&D Elias Zerhouni spoke out claiming that regulations must be harmonized to promote a more global, united pharma industry. While international groups, such as the International Conference on Harmonization (ICH), exist to streamline regulatory standard, Zerhouni is concerned by the fact that North American, European, and Asian regulatory bodies often have differing opinions about drugs’ risks and benefits. It’s these differing opinions that contribute to halted clinical trials, significant label differences, and ultimately, can stall a drug from entering certain markets.

According to Reuters, in 22 percent of cases, the EMA and FDA have had different opinions on whether to approve a new drug. They also don’t often agree on what should be contained in a drug’s label. For instance, one company might be allowed to squeeze more claims of the drug’s benefits into the label following review by one regulatory agency compared to a review by another. These label variations were noted in 50 percent of cases, says Reuters.

Zerhouni’s concerns demonstrate the industry’s continuous desire for quicker drug R&D. As pharma expands its global reach by leaps and bounds, there must be unified regulatory processes in place to maintain a global and streamlined research process and supply chain. The more variations in the amount of time each step to approval takes, the longer it takes to get a drug released into the different markets.

When it comes to ushering a new drug onto the European market, new research released by EuropaBio and the Deerfield Institute revealed that drug makers had more success gaining European regulatory approval when they engaged early with regulatory and health technology assessment (HTA) bodies. In fact, between 2006 and 2014, drugs that received scientific advice two or three times saw 82.5 percent and 88.4 percent approval rates respectively (compared to the 75 percent approval rating for companies that didn’t seek scientific advice from regulators).

Perhaps we’re on the way to our own solution to getting drugs to market more quickly here in the U.S. A new bill was proposed last week in the House of Representatives that would move to cut the “drug lag” that occurs when a new drug is approved in one country before another. In this case, despite the fact the FDA was boasting that it had approved 66 percent of NMEs before other countries in 2014, two representatives are pushing to ensure that the medicines given the green light in Europe first get to U.S. patients sooner.

The Speeding Access to Already Approved Pharmaceutical Act would require the FDA to review a drug that was approved in Europe within 90 days — half the time of the agency’s six month accelerated priority review period. As RAPS discusses, there are several big gray areas that still need to be addressed, including the lack of clarification over whether this bill only covers drugs approved via Europe’s centralized or decentralized procedure. It’s also unclear what the procedure should be for sponsors who file regulatory applications in the U.S. and EU simultaneously.

However, I’m not convinced a push from Congress will lead to the establishment of a 90-day review period. (The FDA didn’t quite budge when Congress tried to push for an approval of new sunscreen ingredients.) Therefore, it might come down to mandating more than just the amount of time the agency spends reviewing a drug. Time is certainly of utmost importance to get drugs to patients in need, but The Hill blog author Paul Howard articulates it well: providing more guidelines to help the organization better evaluate internal performance would boost overall organization and make the agency more efficient. The blog references the oncology division, which currently holds the record of being the most efficient FDA division in terms of drug approval. Howard argues that implementing ways to measure and understand the best-practices of high-performing review divisions, such as oncology, could help spread best-practices for efficiency throughout the whole organization.   

We’ve grown so used to measuring success by the ways we out-rank others — best evidenced by the FDA and EMA comparing differences between approval numbers and times. However, the goals in the industry are all the same: to bring safe medicines to market efficiently for patients in need. Therefore, when it comes down to it, I think we need to look beyond the stats boasting the total number of drugs approved by each agency and the time it takes for them to hit each market. The real accomplishment will be how the different regulatory bodies handle the globalization of pharma and synchronize their approval processes as the pharma industry continues to span continents.