Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Stephanie Sutton

GlaxoSmithKline (GSK) is expecting to pay $3.4 billion to settle legal charges relating to its diabetes drug Avandia, as well as sales and promotional practices in the US for other products. The amount is in addition the $2.36-billion legal charges previously announced in 

 for legal cases regarding Avandia, Paxil, and the company’s former manufacturing site in Cidra, Puerto Rico.  

Since July 2010, GSK says it has continued to receive a “substantial” number of new product liability cases regarding Avandia in the US. The $3.4-billion estimate stems from the company’s assessment of the additional cases and an estimate of likely future claims. 

“We recognize that this is a significant charge, but we believe the approach we are taking to resolve long-standing legal matters is in the company’s best interests,” P.D. Villarreal, senior vice-president of global litigation at GSK, explained in a 

. “We have closed out a number of major cases over the last year and we remain determined to do all we can to reduce our litigation risk.”

The European Medicines Agency recommended that Avandia—once GSK’s biggest grossing blockbuster—be removed from the EU market in September 2010 (see a related 

) because of cardiovascular safety concerns. Around the same time, the US pinned stringent restrictions on the product’s use. 

The charges also relate to an investigation by the US Attorney’s Office for the District of Colorado into GSK’s US sales and promotional practices between 1997 and 2004. According to 

, the charges may wipe out the company’s expected earnings for the first quarter.

Articles

GlaxoSmithKline is expecting to pay $3.4 billion to settle legal charges relating to its diabetes drug Avandia, as well as sales and promotional practices in the US for other products.

Avandia Costs GSK $3.4 Billion

With counterfeit medicines increasingly appearing in legitimate supply chains and even in the clinical stages of product development, a recent white paper has outlined practical steps that may help companies address the issue of counterfeits and diverted products.

, which is based on an industry panel chaired by product development consultancy company Cambridge Consultants, the next few years will see “substantial changes” in the area of anticounterfeiting because of extensive lobbying efforts. In Europe, for instance, there is pressure to ban the repackaging of drugs and to increase the strength of supply chain security. Governments worldwide are also increasing regulations to tackle the problem.

One of the first practical steps that can be taken to protect products is to understand the risks at both a business level and an individual product level, as these will influence the decision as to what safety measures need to be implemented. Public perception is that counterfeit medicines are predominantly in the area of lifestyle drugs, but counterfeit antibiotics and cancer treatments are now finding their way into legitimate pharmacies and hospitals.  

In particular, the white paper notes that many emerging biotech companies do not fully consider the implications of counterfeiting nor implement an anticounterfeiting strategy, despite the fact that some larger companies will be on the lookout for these criteria when assessing potential acquisition targets.  Indeed, some participants in the industry panel explained: “As a minimum, acquisition targets would be aware of the implications of the threat of counterfeiting and have plans for possible product protection.”

Anticounterfeiting measures should be planned early because once a system has been implemented it is significantly more expensive to retrofit it than to build a requirement in from the start. An early start is also beneficial given that counterfeit products and ingredients have been detected in clinical trials.

 One particularly important aspect to any anticounterfeiting business program is technology, and the white paper explains that a layered approach can be advantageous because all technologies have vulnerabilities in their design and implementation. For instance, although serialization enables the detection of counterfeits at Point of Dispense (PoD), it is predicated on the real product reaching the PoD before the counterfeit. According to the white paper, understanding these kinds of factors is crucial, particularly as regulations only provide a minimum standard for compliance. 

Finally, the industry panel noted the importance of ongoing monitoring and continuous improvement, given that counterfeiters will change their tactics. The implemented solution needs to support monitoring and ensure that the process is being executed correctly. 

“Looking further out, as the product protection changes, so to will the criminal’s approach adapt; therefore, a strong system philosophy will also be important to stay one step ahead,” said the white paper.

 Unfortunately, there is no “one size fits all” solution and businesses will need to decide for themselves what measures are appropriate and when they should be implemented. 

Practical Steps To Prevent Counterfeiting

Urgent changes are required in the UK’s regulation and governance of health research because medical advances are currently being stifled by unnecessary delays, bureaucracy and complexity. Acknowledging these issues, a report from the Academy of Medical Sciences has set out a new regulatory and governance pathway.

“We have found unequivocal evidence that health research in this country is being jeopardized by a regulatory and governance framework that has become unnecessarily complex and burdensome,” Professor Sir Michael Rawlins, Chair of the Academy of Medical Sciences working group that prepared the report, said in a 

. “Further, we received no evidence that this increased regulatory and governance burden has led to enhanced safeguards for participants in the research.”

The report recommends establishing a new independent Health Research Agency (HRA) that brings together existing approval processes. The HRA would work with regulatory and governance bodies across the developed nations to develop an integrated UK approvals system. Additionally, the report recommends establishing a National research Governance Service that can facilitate rapid approval of research studies in single or multiple UK National Health Service (NHS) sites. 

“The delay in obtaining NHS permissions is a major failure of the current pathway and is the biggest single barrier to all types of health research studies. There is a highly inefficient emphasis on process rather than outcomes, which has led to delays of over a year to gain permissions for simple studies,” said Rawlins.

The report’s publication has been welcomed by the BioIndustry Association (BIA), which described the report’s recommendations as a “step in the right direction”; however, the BIA also believes that there may be a more effective solution than establishing a new HRA.

“The BIA continues to believe that it would be more efficient and effective to build upon and expand existing competencies within the Medicines and Healthcare products Regulation Agency (MHRA) rather than create a new body,” Alan Morrison, Chair of the BIA’s Regulatory Affairs Advisory Committee, explained in a 

The UK has created nearly a quarter of the world’s top 100 medicines, but recent data has shown a decline in the country’s share of clinical research activity. According to the Academy of Medical Sciences, there has been widespread agreement that the regulatory and governance framework is one of the main contributing factors to this decline.

Urgent changes are required in the UK's regulation and governance of health research because medical advances are currently being stifled by unnecessary delays, bureaucracy and complexity.

UK Regulations Are Too Complex

With dozens of prescription drugs soon to lose patent protection and few likely blockbusters in industry pipelines, drug developers are “aggressively” changing the way they do R&D, according to the Tufts Center for the Study of Drug Development (CSDD).

“The research-based drug industry, in the US and globally, is not sitting still, but the question remains whether developers can bring enough new drugs to market at the pace needed to remain financially viable,” Kenneth I. Kaitlin, Director at the CSDD said in a 

. In particular, companies are looking to reduce development time, cut costs and improve operating efficiency.

According to the Tufts CSDD, actions that will help improve R&D productivity include greater reliance on translational science to help identify the right disease targets for new molecules; greater partnering with external service providers to share risks, reduce cycle times and lower costs; and greater use of sophisticated portfolio management techniques. 

The Tufts CSDD also notes a number of trends that will be important for drug developers to keep an eye on. For instance, according to the Tufts CSDD Outlook 2011, the FDA will be seeking to confront the problems of shortages of antibiotics, emergency drugs, aesthetic agents and drugs for cognitive disorders. The FDA will also be seeking newer and better pain medications. 

Another important issue relates to the location of clinical trials. More than half of all FDA-regulated clinical trials in 2010 were conducted outside of the US, but sponsors are now looking to decrease the number of countries hosting their development activities to reduce problems relating to logistics and regulatory complexities. 

With dozens of prescription drugs soon to lose patent protection and few likely blockbusters in industry pipelines, drug developers are "aggressively" changing the way they do R&D, according to the Tufts Center for the Study of Drug Development (CSDD).

Pharma changes its R&D strategy

With dozens of prescription drugs soon to lose patent protection and few likely blockbusters in industry pipelines, drug developers are “aggressively” changing the way they do research and development (R&D), according to the Tufts Center for the Study of Drug Development (CSDD).

“The research-based drug industry, in the US and globally, is not sitting still, but the question remains whether developers can bring enough new drugs to market at the pace needed to remain financially viable,” Kenneth I. Kaitlin, director at the CSDD, said in a 

. In particular, companies are looking to reduce development time, cut costs, and improve operating efficiency.

According to the Tufts CSDD, actions that will help improve R&D productivity include greater reliance on translational science to help identify the right disease targets for new molecules; greater partnering with external service providers to share risks, reduce cycle times, and lower costs; and greater use of sophisticated portfolio-management techniques. 

The Tufts CSDD also notes a number of trends that will be important for drug developers to keep an eye on. For instance, according to the Tufts CSDD Outlook 2011,  FDA will  seek to confront the problems of shortages of antibiotics, emergency drugs, aesthetic agents, and drugs for cognitive disorders.  FDA will also seek newer and better pain medications. 

Another important issue relates to the location of clinical trials. More than half of all FDA-regulated clinical trials in 2010 were conducted outside of the US, but sponsors are now looking to decrease the number of countries hosting their development activities to reduce problems relating to logistics and regulatory complexities.


Pharma Changes its R&D Strategy

The threat of counterfeit medicines in the next year will be more severe than ever, according to a 

 of 1000 companies conducted in October 2010 by Pharma IQ. More than 60% of the 1000 pharma anti-counterfeiting specialists surveyed believed that the threat of counterfeit medicines would increase and 53.8% have said they intend to invest more in anti-counterfeiting. 

Emerging markets in Asia — particularly China — were seen as the major source of counterfeit drugs (50% of respondents); however, 21.4% of respondents indicated that the internet was also a major threat to the pharma market. Indeed, these views are reflected in an 

 about anti-counterfeiting conducted by Pharma IQ with Sébastien Mauel, Head of Product Security at Ares Trading SA, an affiliate of Merck Serono SA.

“The pharmaceutical industry and the legitimate supply chain are highly regulated, therefore as long as you source your medicines from a reputable pharmacy, the risk of getting a counterfeit product is low. This risk becomes much higher in developing countries where the distribution system is less secure, and also when you purchase medicines from uncontrolled sources, such as certain online pharmacies, which provide no guarantee at all about the quality of the medicines they sell,” said Mauel.

Although emphasis on anti-counterfeiting has been growing in recent years, a number of survey respondents indicated that they were not happy with their current solutions. Only 53% of respondents were satisfied with their current anti-counterfeit technology; more than 23% admitted that they weren’t and 84% said they were looking to invest in new ones.

 According to Mauel, companies are implementing a number of proprietary security solutions and also working on common safety measures to secure the distribution. He also added that well-targeted awareness campaigns would be important to encourage people to always source their medicines from legitimate and controlled suppliers.

Although the survey revealed the significant consciousness of the threat of counterfeit medicines, however, it also revealed great confidence in the ability of the pharma industry to tackle the issue, with almost 85% of respondents optimistic that the industry would eventually win the war. 

The survey was conducted as pre-research for a conference on pharmaceutical anti-counterfeiting, which will take place in February in Amsterdam (The Netherlands).

The threat of counterfeit medicines in the next year will be more severe than ever, according to a survey of 1000 companies conducted in October 2010 by Pharma IQ.