To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers\u27 interest in secrecy and the public interest in disclosure
Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers...
Those committed to the free exchange of scientific information have long complained about various re...
In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current p...
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research da...
Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of...
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhi...
Lassman examines the tension between transparency and other public health interests in the context o...
As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly...
Inventors face a stark choice between two intellectual property systems of protecting innovative ide...
This article addresses the problem of restricted access to industry-sponsored clinical trial data. I...
Federal regulatory agencies in the United States hold a treasure trove of valuable information essen...
Pharmaceutical companies face increasing pressure to bring new treatments to market in order to surv...
Scandals of selective reporting of clinical trial results by pharmaceutical firms have underlined th...
Pharmaceutical companies often replace prescription drugs that are already on the market with modifi...
Context: Changing evidentiary standards and partial shift of the investigational phase of drug appro...
Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers...
Those committed to the free exchange of scientific information have long complained about various re...
In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current p...
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research da...
Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of...
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhi...
Lassman examines the tension between transparency and other public health interests in the context o...
As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly...
Inventors face a stark choice between two intellectual property systems of protecting innovative ide...
This article addresses the problem of restricted access to industry-sponsored clinical trial data. I...
Federal regulatory agencies in the United States hold a treasure trove of valuable information essen...
Pharmaceutical companies face increasing pressure to bring new treatments to market in order to surv...
Scandals of selective reporting of clinical trial results by pharmaceutical firms have underlined th...
Pharmaceutical companies often replace prescription drugs that are already on the market with modifi...
Context: Changing evidentiary standards and partial shift of the investigational phase of drug appro...
Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers...
Those committed to the free exchange of scientific information have long complained about various re...
In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current p...