In a pithy commentary in Nature, Sir Alasdair Breckenridge, Chairman of the MHRA, (et al.) writes:
A life cycle approach to pharmaceutical regulation, in which the benefit–risk balance of new drugs continues to be robustly assessed following market approval, is emerging in both the United States and Europe.
Certainly.
But …
Whether the pharmaceutical industry joins in this consensus and whether companies will serve as willing or reluctant partners in an invigorated post-marketing drug regulation scheme remains unclear. Additional regulatory requirements are never welcome in the short term, and the post-marketing studies that may be required under the life cycle approach may impose substantial costs on manufacturers. However, industry has learned the hard way that inadequate responses to safety signals can have a serious detrimental impact not only on public health but also in economic and reputational terms. The long-term interests of manufacturers and regulators in well-characterized benefit–risk profiles are essentially the same.
The complete article can be found here.
