If it’s Good Enough for the EU is it Good Enough for US? Bexsero in the USA

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In the aftermath of the Meningitis B outbreaks at Princeton University and  the University of California, Santa Barbara, a debate has sparked over whether medicines with marketing approval on one side of the Atlantic should be automatically granted approval across the pond?

When MenB broke out in Pinceton University late 2013 there was no vaccine available in the US which could be given to students to protect them against that particular strain.  Over in Europe however, the European Medicines agency had already given Novartis’ MenB vaccine Bexsero the green light to protect all ages from two months old and upwards.

The US authorities eventually came to an agreement with Novartis, the FDA, and Princeton University and students were offered the vaccination. Bexsero was also approved for a campus wide vaccination scheme at the University of California at the end of January 2014.

That students were eventually vaccinated is of course a relief, but many are still wondering why the FDA had not yet approved a vaccine which was demonstrated, in Phase II trials, to effectively protect against the most deadly form of bacterial meningitis in the developed world? It’s not even as if the EMA are on their own, Bexsero has already received authorisation in Australia and Canada too.

Well last week two researchers from the Manhatton Institute for Policy Research, NY, US waded into the discussion. Howard and Feyman remark on how Bexsero was yet to be approved in the US because of the high standards set out for a phase III trial of Bexsero by the FDA. At the time of the Princeton outbreak the FDA were yet to approve a Phase III trial design for the MenB vaccine.

Howard and Feyman suggest that the way around the delays in vaccinating students this winter is to introduce some form of policy which allows for market access approval to be reciprocated between the EMA and the FDA. They claim that the multiple trials required to gain approval from different regulators are harming patients by increasing costs, and increasing waiting times for patients.

In their argument for reciprocal approval, Howard and Feyman rely heavily on the claim that the EMA and FDA standards are, generally, pretty similar, especially in the case of commonly used and widely available drugs such as painkillers. A further leg of their argument relies on the claim that reciprocity would not result in the EMA and the FDA competing to slash application prices in order to draw clinical research to their continent. Such an idea they simply state is not ‘terribly convincing’.

They then outline what they see as a viable:
“First, reciprocity could be limited to our highly developed trading partners, and to well-understood drug classes or products where there is a high unmet need, like cystic fibrosis or the myriad cancers that don’t respond well to available therapies. Starting with a few classes as a prototype program and using robust surveillance of patient records would rule out the likelihood of another Vioxx-type debacle, where a new and widely used NSAID (a pain-reliever) was linked to as many as 140,000 potential cases of heart disease. Reciprocity could also be optional: Companies could apply for reciprocity, and if either the FDA/EMA declined, they would have to respond, publicly in writing, explaining exactly which regulatory standards the approved application didn’t meet. The drugmaker could also be required to list the regulatory approval standard for the product — EMA or FDA – on the product’s label, so doctors and patients could make informed decisions about whether to use products approved abroad.”
Their last stand is made when they introduce, by way of an example, the struggle between patients suffering from HIV/AIDS 1990s and the FDA who took an exceptionally long tome to approve treatments. Many Patients turned to illegally imported drugs as a result.

So are they right?

Whilst there is of course a strong pursuasive force behind the idea that, had the FDA simply approved Bexsero on the strength of the EMA’s approval, then many Princeton and University of Clifornia students could have been saved from a terrible ordeal.

But as it stands reciprocal approval seems far to bold and sweeping a move to be reasonable based on the evidence and arguments provided by the authors. What the authors are really after here is a system by which the FDA can quickly approve drugs for emergency use that have been approved by organisations of similar standards such as the EMA.

But this is of course what happened with Bexsero. Albeit, not as quickly as we would hope. Perhaps then what the FDA should be looking at is improving the efficiency with which it deals with emergency situations which require the use of medicines not yet approved for use in the US.

This is by no means the end of the debate, but it should at least be seen that moving to a universal approval system is not justified by the MenB outbreaks this winter. But that doesn’t mean that we cannot justify a universal approach in other ways.

What are your views on the reciprocal approval? Should we move towards a universal approval process? Or are the differences in standards required from the EMA and FDA so negligable that when one approves and the other refuses it serves as a better indication of a product’s questionable data  rather than the strictness of a particular regulatory body?

Let us know your thoughts by commenting below.

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