I'm an independent healthcare analyst with more than 24 years of experience analyzing healthcare and pharmaceuticals. Specifically, I analyze the value (costs and benefits) of biologics and pharmaceuticals, patient access to prescription drugs, the regulatory framework for drug
Use of march-in-rights depends on government's interpretation of whether an original patent holder has made products available to the public on “reasonable terms.”
A bill in the Senate would require pharmaceutical manufacturers to include list prices of prescription drugs in direct-to-consumer ads on television and online.
Impediments to biosimilar access prevent market competition from working properly, raise patient cost-sharing and harm long-term sustainability of biosimilar development.
In line with precautionary principle, introduction of treatments whose effects are either disputed or unknown should be carefully reviewed before being routinely adopted.
The FDA may consider approval of the cross-sex hormone estradiol for gender incongruence in adults and minors based on an observational study and not an RCT with placebo.