This time it comes in the form of ‘New Prescription Drug Information Format to Improve Patient Safety’
Superficially, this is a good initiative:
Providing healthcare professionals and patients with clear and concise information about prescriptions will help ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare,” said HHS Secretary Mike Leavitt. “By improving the package insert to make it more useful for healthcare providers in their day-to-day clinical practice, we are making it easier for them to explain the benefits and risks of medications for their patients.
I would not fault the laudable and wholly worthwhile intentions. Avoiding death and harm is a good idea. This is, after all, why pharmaceutical companies are required to spend millions on testing the effectiveness of new medicines, and the likely side effects or interactions with other medicines. It’s only when they have done all these things to the satisfaction of agencies like the FDA that they are allowed to market the medicine. In other words they have to provide EVIDENCE that the medicine does what they say it does.
But then we come to the information that goes with the medicine.
The FDA is fully aware that medicines are information dependent products. Without information medicine is unusable and dangerous. But where is the EVIDENCE that the information is ‘clear and concise’, or that the FDA is ‘making’ it easier for