Thursday, 29 May 2014

The Regulator’s balancing act

Many patients as well as those in pharmaceutical companies can become frustrated with regulatory agencies when a decision does not match their views. Yet however difficult these regulatory setbacks are to accept, it is important to remember that regulatory agencies are government bodies and are therefore ultimately accountable to the public. For example, in Japan, the cancer drug Iressa (gefitinib) caused a series of adverse events in patients and a number of people died from pneumonia-like illnesses. The country’s regulatory body, the Japanese Ministry of Health, Labour and Welfare (MHLW), was publicly criticised over its role in the approval of the drug. In the US, One of the most damaging episodes for the US Food & Drug Administration (FDA) was Merck’s COX-2 inhibitor Vioxx (rofecoxib), which was withdrawn from the market after being linked to an increase in the risk of heart attacks and strokes.

Public safety is paramount and so decision-making within regulatory bodies must be geared towards this factor rather than external expectations. The European Medicines Agency’s (EMA) own mission statement states the Agency’s intention to “foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public.” The FDA describes its role in similar terms in its Mission Statement.

Ironically, regulatory agencies are often accused in the media of being too “close” to the pharmaceutical industry and have even been sued by consumer groups. Regulatory agencies must constantly find a balance in dealing with the pharmaceutical industry so as to encourage drug development but also demonstrate to those outside the industry that their decisions are impartial and transparent. Reviewers must weigh the information available about a drug’s risk and benefit, make decisions in a limited time in the face of scientific uncertainty, and integrate emerging information bearing on a drug’s risk-benefit profile throughout the lifecycle of a drug, from drug discovery to the end of its useful life. Regulatory processes may have life-or-death consequences for individual patients, and for drugs that are widely used, they may also affect entire segments of the population. Reviewers must therefore strike a delicate balance in judging the drug’s risks and benefits, and whether the need for more information from studies to increase certainty before agency approval, warrants delaying the release of the drug into the marketplace and into the hands of health care providers and their patients.

Latest regulatory affairs jobs

Thursday, 22 May 2014

Pharma’s important role as an employer

As well as being a major producer of medicines, the pharmaceutical industry is a vitally important contributor to the economy, particularly as an employer. For example, in the US, the sector employs more than 810,000 workers and indirectly supports a total of 3.4 million jobs across the country. In the UK, the industry employs around 68,000 people of which 23,000 work in R&D. According to the European Federation of Pharmaceutical Industries and Associations, the industry directly currently employs 660,000 people in Europe and generates between 3 to 4 times additional employment indirectly. Therefore, while many European governments have focused on cost containment measures as a means to curb healthcare spending they remain nervous about putting too much pressure on pharmaceutical companies because of the impact it might have on their investment in the region.

Companies have been grumbling for a number of years about the tough operating conditions in Europe and hinting that they may shift investment to other regions, particularly emerging markets. Over the past few years there have been a series of high profile job cuts in the European pharmaceutical sector, with companies linking such measures to the unfavourable operating environment. For politicians these measures could not be taking place at a worse time. With Europe in the midst of economic crisis and governments struggling to create new jobs, the role of the pharmaceutical industry as a major employer is critical to economic recovery.

The wide-ranging impact of a pharmaceutical company’s decision to cut jobs is illustrated by Pfizer’s 2011 closure of its R&D base at Sandwich, Kent. Unions complained about the government’s economic cutbacks and highlighted that the jobs being lost at Pfizer’s facility were the type that the UK needed to preserve for economic recovery and that the move would devastate the local region.

The UK is not the only country where national politicians have found themselves under pressure as a result of pharmaceutical industry job cuts. France has been experiencing a similar situation due to Sanofi reorganising its global operations. In July 2012, the national newspaper Le Figaro reported in July 2012 that up to 2000 jobs might go as part of a Sanofi drive to reduce the workforce. The French government was forced to reacted quickly, as it was already facing considerable public criticism for being unable to kickstart the economy and due to imminent job cuts in the automotive sector. It held behind the scenes discussions with Sanofi which led to the company announcing that it would cut fewer jobs and a commitment to maintaining its existing sites in France.

European governments need to be mindful regarding potential job cuts within the pharmaceutical sector and engage with companies to safeguard employment. In late 2012, GlaxoSmithKline’s CEO painted a depressing picture regarding company’s view of the European market, with analysts linking such statements to future job losses.

Latest pharmaceutical jobs