Should FDA and EMA Team up to Approve Drugs on a Reciprocal Basis?

| 18 February 2014 | By Alexander Gaffney, RAC

If you ask any regulatory professional who the most eminent regulatory bodies in the world are, most responses will undoubtedly list two: The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

They'd be on that list for good reason. Nearly every single drug or therapy of note is first approved by one of the two regulators. They are better funded than any other drug regulators on earth. They have deep and well-renowned pools of experts and staff on which they rely. And their respective regulatory decisions are often closely followed by other countries.

The Case of MenB

But a new opinion piece in Health Affairsraises an interesting question: Based on the competencies of each regulator, why are they duplicating each other's review processes in the pursuit of (almost always) the same conclusions?

Paul Howard and Yevgeniy Feyman, both of the conservative-leaning Manhattan Institute, take note of several outbreaks of meningitis serogroup B (MenB) at colleges throughout the US. While the US has no FDA-approved treatments or vaccines to prevent the disease, EMA has approved Novartis' vaccine Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]).

In December 2013, FDA approved the Centers for Disease Control and Prevention's (CDC) Investigational New Drug (IND) application-essentially a clinical trial application-to help stop the bacterial infection from spreading to additional students.

In a statement, Novartis said it remains "committed to continuing the dialogue with the FDA to find a licensure pathway to bring a MenB vaccine to the US to fulfill this unmet public health need for the future."

But should they even have to? Howard and Feyman argue in their Health Affairs piece that approval by EMA (and others) should be sufficient to support approval here in the US.

'Shouldn't be so Hard'

"It shouldn't be so hard to approve products that have already been vetted by other trusted regulators abroad," they wrote. They go on to argue that despite the two regulators' varied standards for approval, there exists a "case for reciprocity" since both regulators have relatively similar safety standards for pharmaceuticals.

They go on the hedge this argument in a few caveats: Such approvals should be (at least at first) only given to those drugs where the biological underpinnings of a disease are well understood, and where there are robust postmarket surveillance tools already in place. They note that based on FDA and EMA's interactions in other regulatory harmonization efforts like the International Conference on Harmonisation (ICH), "This wouldn't be a heavy list for the agency."

Trouble Spots

But even still, the authors note some of the reasons why this might not be feasible. And issue number one seems to be user fees, which the authors postulate that the regulators might fear losing.

Regulators might also fear an "exodus" to regulatory bodies that offer the path of least resistance-or the least regulation-taking their user fees with them, damaging the reputations and experience of the other regulator.

Over time, that exodus could also compound into a loss of regulatory experience at one regulator, leaving it less able to regulate products.

Avoiding a Race to the Bottom

But the authors say several caveats and protections make a "race to the bottom" unlikely.

For starters, Howard and Feyman said any reciprocity would be "limited to our highly developed trading partners," and even then to those drug classes that represented highly unmet needs in biologically well-understood areas. Pilot programs constrained to certain drug classes and paired with extensive postmarketing surveillance programs might also help.

As a control measure, companies would also need to apply for reciprocity, much in the same way they can now apply for single-state approval in the EU or reciprocal approval from all states through EMA's centralized procedure. If either EMA or FDA declined to approve a drug reciprocally, they would have to have to respond publicly and explain "exactly which regulatory standards the approved application didn't meet."

As per labeling of the products, the approved drug would need to list the approval standard used to bring the product to market (e.g. FDA or EMA).

Howard and Feyman noted that US tort laws would serve as a powerful hedge against any company that sought to bring a substandard product to US consumers, even as the approval standards of other highly-developed countries would likely make that an unlikely possibility.

The PEPFAR Precedent

The authors' proposal, while representing a significant departure from current FDA and EMA policy, isn't entirely novel, even for FDA.

Perhaps the most obvious example of approval is found in the President's Emergency Plan for AIDS Relief (PEPFAR), a piece of legislation that established a multibillion-dollar effort to fight AIDS. One of the cornerstones of that effort is an FDA review program that grants tentative approval to AIDS medications, allowing resource-constrained regulators from low- and middle-income African countries to rely on evidence evaluated by experienced regulators.

Without the capacity to properly review those applications, local populations could be subject to lengthy waits or-worse-unsafe medications. To date, FDA has approved more than 150 applications under the PEPFAR program, making them available for use by PEPFAR member countries. Twenty-seven of those drugs were new drugs, while the remainder were generics.


Health Affairs Piece


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