Drug regulators only have two speeds, as an old gag puts it: Too fast, and too slow. That’s certainly the perception in this pandemic.
As Western nations begin to roll out the first batch of promising vaccines against Covid-19, with the UK leading the charge and the US the latest to follow suit, the gatekeepers whose job it is to supervise their efficacy, safety and distribution are in a very tough spot.
The pressure to go fast is immense. This once-in-a-century pandemic has claimed over 1 million lives worldwide. Lack of a cure has led to medieval-style, economy-crushing lockdowns. The likes of Donald Trump regularly berate regulators for perceived slowness.
Now the urge to win points for speed risks backfiring as regulators indulge in one-upmanship, undermining trust.
The UK regulator’s world-first approval of the Pfizer-BioNTech vaccine for emergency use this month, which should have been unambiguously good news for science, was unhelpfully proclaimed by UK politicians to be a Brexit victory against “slow” European peers who didn’t have “the best medical regulators.” The European Medicines Agency shot back that the Brits had been “hasty” instead of safe. The Food and Drug Administration’s Anthony Fauci agreed, before walking back his comments.
Maybe if vaccine skepticism — polling around 40% in Western Europe — were less widespread, this mudslinging might not matter so much. These regulators have different processes for a reason. The FDA, as befits a centralized US entity, does things transparently: Members of a key advisory committee spent all day Thursday debating authorization live via webcast before giving the all-clear. The EMA is a more typical European creature, corralling 27 EU members into a single market. It’s taken pride in slowness as a badge of “safety,” but probably also to comfort consumers and dissuade those member states like Hungary that want to test Russia’s vaccine.
Yet the finger-pointing over speed and safety ignores that this is a marathon, not a sprint. Initial vaccine batches have only just been delivered, and supervisors have to be alert to any possible unwanted surprises. The UK’s first-mover advantage has made it a laboratory of sorts: News of two significant allergic reactions this week jolted its Medicines and Healthcare products Regulatory Agency into issuing a new advisory that those with a history of allergies should stay away from the vaccine. Surely regulators should be learning from each other, rather than competing, as more people get the shot.
Thomas Lonngren, who ran the EMA between 2001 and 2010, says the tit for tat is sending the wrong signal by making it seem these agencies are working at cross purposes. “I’m not really happy with this idea of a competition,” he tells me. “All regulators are working closely in this pandemic.” Today, as an advisor to vaccine companies, he reckons a better approach to authorizations would have been for regulators to agree them simultaneously or issue a joint declaration, rather than seeding ill-will for a question of a couple of weeks’ difference.
On top of more cooperation, there might be benefits to taking a more methodical path. Switzerland, blessed with a relatively low death count, has no emergency authorization procedure to speak of and plans to take a few more months to collect data from countries that are starting inoculations. Vaccine expert Claire-Anne Siegrist, labeled the “high priestess” of Covid vaccines in the Swiss media, reckons a more cautious approach that brings together quality information and data can help win over the hesitant. After all, only widespread use will kick this virus.
Still, competitive urges are unlikely to abate soon: Brexit from next year will rob the MHRA of unfettered access to a single market for pharmaceuticals and talent, while the EMA loses a well staffed and technically proficient partner regulator. The British response may be to look for options to deregulate. In 2017, Michael Gove, now UK cabinet minister, suggested Brexit could allow the UK to tear up “absurd” EU rules on clinical trials. Tamara Hervey, a law professor at Sheffield University, reckons while there’s scope for regulatory divergence and new routes to drug approval, the UK will face challenges as a smaller market exposed to trade barriers.
All of which suggests the current environment will leave lasting side-effects, not just in vaccines but in drugs and devices more broadly. Instead of competing, it makes more sense for gatekeepers to work together or risk falling into a reputation trap.
Bloomberg
