Bayer Healthcare's Stephen Klincewicz speaks on global pharmacovigilance regulations
Conference producing company marcus evans has interviewed Stephen L. Klincewicz, global head of drug safety for Bayer Consumer Care, in advance of its upcoming Global Pharmacovigilance and Adverse Event Reporting Forum, May 11-13th in Philadelphia. Klincewicz will be speaking at the conference, which brings together industry executives to examine how to develop innovative methods of signal detection and mitigating adverse events. http://bit.ly/gu9L5E
Q: What are some of the increasing complexities in managing drug safety?
A: Over the past decade there has been a lot of interest in global regulatory harmonization, as evidenced by the many ICH and CIOMS initiatives. While there have been a lot of successes, there are still some differences, for example, between member states in the E.U. and between the U.S., E.U. and Japan. The challenge for medicinal product companies will be to recognize these differences and not expect a "cookie cutter" approach to product safety.
Public access to information about drug safety is increasing. If you look at the websites in the E.U. and U.S., more real-time information is available to consumers than ever before. Even PSURs are now available to the public.
Social media may be having a big impact. Product benefits as well as risks (real or perceived) can now be discussed online in real time and often with little or no opportunity for informed health care professionals to weigh in.
Q: How effective has the FDA Modernization Act been in ensuring public confidence in medicines?
A: The FDA modernization act affected a broad range of medicinal products, and I think it's hard to make a generalization. Certain aspects of the legislation, for example, the requirements around clinicaltrials.gov, have really provided consumers with an unprecedented visibility into the drug development process. But since many of the provisions have been enacted we have still had some highly visible product withdrawals and recalls. There is no easy answer to instilling public confidence, since there will always be a tight balance between access to innovation and absolute product safety.
Q: Regarding EMEA legislation and rulings—how are these working to ensure drug safety across the globe?
A: Each national and supra-national pharmacovigilance (PV) system is different. The E.U. were pioneers in focusing on the establishment and oversight of the entire PV system, and they also have established innovation through many scientific committees that thoroughly and expertly review safety issues. Their EPAR (European Product Assessment Report) provides transparency and access not only to E.U. citizens, but globally. Each of the global health authorities has a different approach to PV. And rather than trying to harmonize, I think that a PV professional's time is better spent thoroughly understanding the different systems and adopting best practices.
Q: Do you believe increasing the time to approval for new pharmaceutical drugs may increase the likelihood of unsafe drugs entering the marketplace?
A: There is always a balance between innovation and access. Statistically, for example, you are not going to change the size of a population required to make predictions about some aspects of a product’s safety. As you demand more precision and quantization of risks and benefits, development time and regulatory assessment time will increase. And it is the actual way the products are used that will determine the ultimate benefit risk profile of the product. The real question is: how to we do monitor this product use after launch? There has been some progress in this area with the advent of REMS, RMPS and new surveillance systems such as the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP). A big question is how we can assure safe use in the increasingly important developing markets.
Q: How can Pharmacovigilance be optimized to fight substandard and counterfeit medicines?
A: It has been pretty clear in recent years that there is an inseparable link between pharmacovigilance and manufacturing quality assurance. However, the methods for detecting adverse reactions that are attributable to substandard manufacturing or counterfeit products are still poorly described and evaluated. There has been a lot of progress in supply chain management such as bar codes, holograms, controlled distribution etc., but I really believe that agencies and manufacturers should continue to develop better methods to assess the link between product quality and health outcomes.
Q: What are the best practice methods for collecting adverse event data from patients and physicians?
A: The best methods are those that work for the evaluator! There has been a lot of emphasis on "collecting everything," even though a product safety profile has been pretty well established. While these processes have helped PV to become established as a discipline, everyone needs to take a hard look at processes and procedures that add no incremental value to the benefit risk assessment of a product. Cost is an issue to everyone these days, and it makes much more sense to target resources where they have the greatest impact.
Stephen L. Klincewicz is global head of drug safety for Bayer Consumer Care. Previously, he was global head of benefit risk management for Johnson and Johnson. He began his pharmaceutical career in 1999 at AstraZeneca.
For more information on the upcoming conference, contact Lindsey Silvetti at Lindseysi@marcusevansch.com.