Latest From Ed Silverman
Increasing scrutiny is being placed on trial sponsors and regulators to improve trial data reporting. Researchers complain that, without access to specific data, results cannot be easily duplicated, which inhibits greater understanding of how medicines might work, adversely affecting treatment decisions and health care costs. Are penalties and public reprimands enough to change behavior?
Exploring the continued controversy around the 340B US federal drug discount program. As the story moves into 2022, key questions remain unanswered.
The divide between developed and developing countries for access to health care innovations has been spotlighted by the ongoing COVID-19 pandemic. Civil society groups pile on the pressure.
The race to develop COVID-19 vaccines is intensifying long-standing debate over the ability of lower-income countries to gain affordable access to needed medical treatments. Patient advocates argue that drug makers and wealthy governments are striking deals that place poor countries at a disadvantage. The pharmaceutical industry, however, maintains it is moving as quickly as possible to not only discover safe and effective vaccines, but to enable equitable distribution.
Some believe unmet need refers only to rare diseases and tiny patient populations. But it is more than this. In 2020, the term sits at the heart of decision-making for drug makers – along with cost, access and value, of course.
Over the past few years, frustrating instances of shortages and recalls – particularly generics – have been blamed on inferior quality control at countless suppliers of active pharmaceutical ingredients and finished products, especially those based in India and China.