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Drug Safety in the Post-Vioxx Era: New Legislation, Regulation and Company Strategies in Europe and the US
Business Insights, July 2005
How is your company addressing the issue of drug safety...?
Assess the new drug safety strategies your competitors are using in this latest report...
Merck's voluntary withdrawal of Vioxx in September 2004 and the ensuing investigation of regulatory checks and balances have raised awareness of safety issues to unprecedented levels. Although Vioxx represents the most severe safety scare to date, similar problems could occur again given the commercial availability of various products that have been linked to widespread severe reactions and the lack of sufficient regulatory controls.
'Drug Safety in the Post-Vioxx Era: New Legislation, Regulation and Company Strategies in Europe and the US' is a new report which examines the actions taken by legislative and regulatory bodies in response to recent drug safety concerns surrounding the COX-2 inhibitors and antidepressants. Implement a variety of proactive management, marketing, distribution and technological strategies to ensure the safety of your products and prevent exposure of drug safety issues for the public.
Develop a tighter drug safety strategy by analyzing nine case studies describing safety issues encountered by pharmaceutical companies and examine the predictions for the future of drug safety regulation in the US and EU.
Key findings of the report
- Lawsuits due to Vioxx are likely to cost Merck at least $10bn to $15bn, the most of any drug lawsuit to date.
- Reported adverse drug reactions are at an all time high and are expected to continue to grow at a double-digit pace, in part due to the high susceptibility of the growing senior population to adverse events.
- The latest EU-level proposals address various issues including pediatric testing, the manufacture of active pharmaceutical ingredients (APIs) according to Good Manufacturing Practice (GMP), and labeling.
- In February 2005, Senators Christopher Dodd (CT) and Charles Grassley (IA) introduced a bill to the US senate to require the public disclosure of all new clinical drug trials by pharmaceutical companies - the 'Fair Access to Clinical Trials Act' of 2005.
- Several pharmaceutical companies have recently withdrawn drug applications in order to collect more comprehensive safety study data, particularly for candidates with questionable safety profiles or those belonging to classes associated with heightened risk.
- Counterfeiting is a growing area of concern in the EU and US and is another factor compromising drug safety for pharmaceutical companies. Several bills have been proposed in the US Congress to expand the FDA's powers to address counterfeit drugs.
Key questions answered in this report
- Which manufacturers have had significant safety breaches and how did they occur?
- How are your competitors responding to safety challenges and how does your organization compare?
- How could legislative changes boost regulators' authority over the industry and how will this affect your company?
- What regulatory changes have been proposed in the US and EU, and how do these differ?
- How are managed care organizations and retailers responding to recent safety concerns regarding the COX-2 inhibitors and the issue of drug counterfeiting?
Top five reasons to order your copy today
- Anticipate regulatory and legislative changes in Europe and the US that may impact how you address drug safety issues and assess potential changes that may need to be made to your current drug safety strategy.
- Analyze new trade group initiatives and proactively work with trade organisations to provide more transparent information to physicians and patients and highlight drug safety concerns early.
- Discover how managed care organizations and retailers are reconfiguring their business models to improve the safety of drugs they provide to consumers.
- Benchmark your drug safety strategy against your competitors by analyzing management, marketing and technological strategies companies are pursuing.
- Develop innovative future strategies by utilizing the report's nine case studies of leading pharmaceutical companies including GlaxoSmithKline, Pfizer, AstraZeneca, Eli Lilly and Merck & Co.
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