Pharmaceutical Technologist - July 2007 - (Page 11)

// Morpheus regulatory agency for most international companies. Despite the agency’s promises to improve, the pharmaceutical industry continues to complain that the review process in Japan is slow, thus creating a backlog of applications. Trying to work out why regulators come up with their strange conclusions regarding the work we have submitted often seems pointless. There will be countless occasions where their thinking appears as clear as mud. Furthermore, no sooner have they given you guidance, the rules completely change and you are expected to fulfil totally different standards to get your drug approved. How are you supposed to start a project when the rules might change half way through it? Even asking the regulators for advice before you start doesn’t save you from falling into this trap. Yet perhaps we need to be a bit more objective about what the regulatory agencies do. Our view is that they should approve important new medicines so that patients have access to better therapies than those that already exist on the market. This is why some of their decisions can drive us insane, as they can hold up products for long periods in endless reviews. However, their role is not to make the pharmaceutical industry happy. Their overriding role should be to protect the public so that only the best medicines make it to the market and to ensure that safety concerns regarding existing and new medicines are addressed on an ongoing basis. Public safety is paramount to them and so, quite honestly, our commercial concerns will seem rather irrelevant. Everyone hates bureaucracy, but as long as regulators are fulfilling their main role then, to an extent, we just have to grin and bear it. So given this interpretation of the regulatory agencies’ role we would expect the public and media to be enthusiastic about their work. Unfortunately, this is far from the case. When patient organizations and advocacy groups lobby a regulatory agency to advance treatments for an unmet medical need through the regulatory process, then that works to the benefit of the pharmaceutical industry. However, most of the time the public and the media believe that the regulators favour the pharmaceutical industry in their decision-making. After all, it is not unheard of for people who have previously worked in regulatory agencies to subsequently find employment with pharmaceutical companies and to a lesser extent vice versa. In the US, user fees and the involvement of outside experts for scientific advice have led to the regulators coming under suspicion for industry collusion. There has even been the odd scandal involving regulators, which the media have been quick to pick up on. A 2004 editorial in the BMJ highlights the issue of a whistleblower at FDA who encountered difficulties in raising concerns over Vioxx when it was going through the approval system.1 The article also criticises the UK’s MHRA for its ties with the pharmaceutical industry, implying that issues of transparency and competing interests were not being addressed. In short, could two of the world’s leading regulatory agencies be trusted? Everyone hates bureaucracy, but as long as regulators are fulfilling their main role then, to an extent, we just have to grin and bear it. However, a bigger blow to the reputation of the regulators was the resignation of FDA commissioner Dr Lester M. Crawford and the subsequent news that he faced accusations of financial improprieties and false statements to Congress.2 If we look further afield the situation hardly improves. In China, the market that every pharmaceutical company sees as the promised land, six senior officials from the State Food and Drug Administration (SFDA) were accused of bribery and arrested in early 2006. Official reports even suggest that a number of other agency personnel may have been involved.3 These types of stories have led to an erosion of public support across the world for regulatory agencies, and the belief that they are too friendly with the pharmaceutical industry. How ironic, when those of us in the industry often feel that regulators are standing in the way of progress in getting an important product onto the market. So next time you are dealing with a regulator, although you may not want to be their best friend, do spare a thought for them. It can hardly be much fun trying to keep both the pharmaceutical industry and the public happy. Perhaps when regulators arrive home from their jobs and switch on the television, they are the only ones who appreciate the work of football referees. PT References 1. www.bmj.com/cgi/content/full/329/7477/0-g 2. www.washingtonpost.com/ wp-dyn/content/article/2006/10/16/AR2006101600569.html 3. http://english.gov.cn/2006-02/08/content_181695.htm www.ptemagazine.com 11 http://www.bmj.com/cgi/content/full/329/7477/0-g http://www.washingtonpost.com/wp-dyn/content/article/2006/10/16/AR2006101600569.html http://english.gov.cn/2006-02/08/content_181695.htm http://www.ptemagazine.com

Table of Contents for the Digital Edition of Pharmaceutical Technologist - July 2007

Contents
Editor's Comment
News
Morpheus
Market Watch
Market Trends for Self-Injection Technologies
Special Delivery
Q&A

Pharmaceutical Technologist - July 2007