The balance of free speech and patient safety is being debated, as it concerns a draft guidance issued last year from the FDA that would allow drug makers to give physicians new information that "rebutes, mitigates or refines" information about existing risks that appear on their drug's labeling, according to The Wall Street Journal.
The FDA has written they understand the safety profiles of drugs evolve over time and this new guidance could be helpful to healthcare practitioners.
Drug makers have pushed the FDA for more lenience to distribute information about their products to physicians so long as they are truthful, and proposed FDA guidance is welcomed by the pharmaceutical industry, reports The Wall Street Journal. However, some physicians and critics of the guidance say patients may be harmed because the manufactures of drugs may down-play important risk information associated with their product.
"Companies have a fiduciary responsibility to shareholders to increase sales of their products. This creates a conflict when it comes to medication safety, as information on harmful effects and required restrictions on use lead to limits on sales," wrote Barbara Mintzes, an associate professor in the University of British Columbia School of Population and Public Health, to the FDA.
Public Citizen senior advisor Sid Wolfe wrote the FDA last week to "immediately withdraw this reckless and justifiably embarrassing proposed guidance, because it seriously undermines FDA authority," reports The Wall Street Journal.
While some pharmaceutical companies applaud the FDA guidance, others want the FDA to allow them to not only update risk information, but to allow them to distribute information about their medicine's effectiveness, reports The Wall Street Journal.