Abstract
The US leadership election has now been settled and most observers are trying to work out what the implications are for the Pharmaceutical Industry. At the time of writing, it seems to indicate a lot of uncertainty.
After a presidential directive, all US Health Agencies have been told to cancel external meetings, travel, regular scientific reports, health advisories, updates to websites, social media posts, food recalls and public health threat announcements. This must also have caused a major disruption to global pharmaceutical factory inspections. In parallel, the USA has announced it will withdraw from the World Health Organisation in 12 months-time on the grounds that the WHO mishandled the covid pandemic. All this may be rescinded or amended but, in the meantime, it has generated great concerns in the Public Health Community.
Previously the generic industry had been asked by the FDA to stay engaged with meter dose inhalers in the treatment of asthma. However, many industry executives with long memories will remember the last time there was a change in CFC gas propellants in meter dose inhalers which generated a lot of turmoil for many years.
The US Centres for Medicare & Medicaid Services recently identified the next 15 additional drugs that will soon be subject to price negotiations. However, the Inflation Reduction Act (IRA) Act has been heavily criticised by the new USA administration so more changes could take place.
A number of questions on generic medicines have been posed to RFK Jr who is likely to hold a key leadership role in USA healthcare but the answers are still awaited.
The Federal Trade Commission (FTC) has exposed the the top three largest Pharmacy Benefit Managers (PBM) to have taken $7.3 billion through significant inflated mark-ups of medicine prices during the 5 years from 2017 to 2022. This will only increase the new USA administration’s focus on medicine prices. All together this represents a very uncertain period for the world’s leading pharmaceutical market.
In this issue, we continue with our global footprint of manuscripts with contributions from USA, UK, India and France.