For this public declaration, Hamburg has http://www.healthcarepackaging.com/trends-and-issues/global/ex-fda-head-drug-regulations-have-failed t=_blank]joined forces with Elias Zerhouni, who is the research head of French-based pharmaceutical company Sanofi. Together, the two called on global governments to work together to make patient access to new medications easier. In doing so they argued that existing drug regulations hamper the process of getting needed medicines to the market quickly enough.
The joint statement has been made in the form of http://stm.sciencemag.org/content/8/338/338ed6 t=_blank]an editorial to the journal Science Translational Medicine (“The need for global regulatory harmonization: A public health imperative.”)
http://www.reuters.com/article/us-pharmaceuticals-regulations-idUSKCN0Y229F t=_blank]In a follow-up interview, Zerhouni said: “Drug development is global and we need to have safety and efficacy data globally, so we should have a global system, just like with airplanes.”
This was a reference to the long cycle when, after a drug has completed its clinical trial path, it is required to go through different rounds of registration in different markets. Here a pharmaceutical company will register a product in the U.S. and receive a run of questions from FDA, which can take three to six months to complete. Then the product is registered in Europe, receiving a similar batch of questions; and then in China and so on. An analogy would be a mosaic or jigsaw puzzle, leading to the eventual global registration of a medicinal product.
The same argument could also apply to regulation inspections against Good Manufacturing Practice (GMP), designed to examine the safety and efficacy of medicines. Here a pharmaceutical company may be subject to successive inspections by different regulators, looking into the same issues.
This is reflected what the two have written in the editorial, which runs: “we would challenge governments, including congresses and parliaments, presidents and prime ministers, to put harmonization on their agenda.”
The issue has generally proved popular on social media, with several tweets in favor.
In terms of a way forwards, to overcome medicine registration barriers, Hamburg and Zerhouni call on reforms to be made at the level of the G20 leading group of industrialized nations.
