Q: Is too much regulation killing drug development?

—Philip Sasson, Director, Sasson Ltd.

A: I think it’s far too easy to blame everything on regulations in terms of the downturn for drug development. Someone always gets a drug to market so the regulations cannot be the whole answer. A number of companies have just become less and less productive over the years and their attempts at reorganizing themselves structurally or looking for mergers and acquisitions would suggest that they know that some factors for productivity lie within their control.

Regulations are essentially there for public safety and given some of the scandals that have happened over the past few years some would argue for more regulation not less. Every time there is such a scandal the public (whom regulators must ultimately answer to) focuses on the regulatory agency. Maybe what would be better is improved dialogue between industry and regulators. For example, there are opportunities to get scientific advice earlier on in the development process but not every company makes use of such opportunities. Equally when regulatory agencies give an opinion on something they need to do a better job in explaining and justifying things. We are seeing some changes through the introduction of “regulatory science” where some context is being added around decisions. Regulatory agencies also have limited resources since they are run by government. If they are to improve then they need better resourcing and funding to do their job.

—Faiz Kermani, SFL Regulatory Affairs