Health Canada, FDA Announce First-Ever Approval Under Joint Review Process
Posted 12 December 2012 | By
Regulatory agencies are often seen as being in competition with one another. When the European Medicines Agency (EMA) approves a cancer drug before the US Food and Drug Administration (FDA), that's seen not only as a win for EU regulators, but as a loss for US regulators as well (barring, of course, any safety issues).
But in at least one area, that view of regulatory as a zero-sum game may be changing.
In an announcement made on FDA's website on 12 December 2012, two of the agency's top regulatory officials said that its veterinary staff had participated in the first-ever "simultaneous review and approval of a veterinary drug" with Health Canada.
Under that process, FDA and Health Canada regulators sat down under the terms of a 2011 regulatory agreement to review-together-effectiveness data for Elanco Animal Health's new animal drug application (NADA) for Comfortis (spinosad chewable tablets), a flea treatment for cats and dogs.
"The simultaneous review process is an opportunity to work more collaboratively with our counterparts at VDD on products we both are working on, but it does not guarantee that each agency will come to the same conclusions," Gloria Sanchez-Contreras, an FDA spokeswoman, told Regulatory Focus. "For the simultaneous review of Comfortis, FDA and VDD reviewed the same effectiveness data simultaneously, but reviewed the remaining technical sections separately. For Comfortis, all of the safety, effectiveness, and quality standards for each country were met to allow a simultaneous approval in both Canada and the US."
The drug apparently received approval through the process on 20 August 2012, and it remains unclear why the product's approval is only being trumpeted by regulators now, nearly four months later.
Though the review was through the agencies' veterinary departments-the Center for Veterinary Medicine at FDA and the Veterinary Drugs Directorate (VDD) at Health Canada-the model has been discussed at times as one that could potentially be spread to human pharmaceutical and biopharmaceutical products as well due to the relative similarities between approval systems.
The review process went well enough for regulators to think about expanding it to more veterinary products, FDA noted. "Regulatory in both countries have determined that several other veterinary drugs are also potentially eligible for simultaneous review by both countries under the Regulatory Cooperation Council (RCC) action plan," wrote FDA's Bernadette Dunham, director of CVM, and Murray Lumpkin, senior advisor and representative for global issues.
The two agencies expanded their 2011 agreement in a May 2012 document known as the Veterinary Drugs Work Plan. [See: Regulatory Focus' 30 July 2012 story, "US, Canada Announce Extensive New Harmonization Efforts.]
"Because of this successful initial collaboration, there is much potential opportunity going forward to continue to improve our review efficiency and the use of our review resources to improve access to safe and effective products on both sides of the border," Dunham and Lumpkin added.
In a separate statement, FDA said the two agencies "plan to build a process to allow simultaneous submissions and collaborative reviews where possible." Each country would maintain the right to prevent a product from being approved in their country if they don't believe it should be marketed.