Prevalent diabetes at the time of heart failure (HF) diagnosis is associated with a higher risk of death, but the incidence and prognostic importance of new-onset diabetes in patients with established HF remains unknown. Patients with a first hospitalization for HF in the period 2003–2014 were...

A number of different proposals and research and development (R&D) models for stimulating antibiotic innovation have been proposed, each differing with respect to characteristics such as the type and timing of innovation incentives and the degree of governmental public control of the market. For...

Once every five years, Congress re-authorizes funding for the FDA under PDUFA. In the current PDUFA legislation, Congress also addressed issues relating to antimicrobial resistance in the Generating Antibiotic Incentives Now (GAIN) Act. This short article critiques the absence of antimicrobial...

One purpose of the individual mandate is to eliminate the market for self-insured healthcare transactions. It is well-established in this Court's precedent that the elimination of an interstate commercial market is a constitutionally legitimate end for Congress to pursue under the Commerce...

The pharmaceutical IP system works well in high-income countries able to afford government subsidies and social insurance. It does not work for the poor in low and middle-income countries. For global diseases (Types I and II), innovation is assured by high-income country markets alone,...

Drug prices are uniquely susceptible to radical price reductions through generic competition. Patented pharmaceuticals may be priced at more than 30 times the marginal cost of production; the excess is the patent rent collected by the drug company while the patent and exclusive marketing periods...

Penicillin and other antibiotics were the original wonder drugs and laid the foundation of the modern pharmaceutical industry. Human health significantly improved with the introduction of antibiotics. By 1967, the US Surgeon General declared victory over infectious diseases in the US. But pride...

The Australia-U.S. Free Trade Agreement (AUSFTA), which entered into force on January 1, 2005, contains many remarkable provisions of interest to generic drug companies. The AUSFTA selectively exports U.S. generic drug laws of great import to generic drug manufacturers, and is uniquely intrusive...

On April 19, 2005, the US Senate HELP Committee held long-delayed hearings on importing cheaper foreign drugs (the Dorgan-Snowe bill, S.334). At the Hearing, Dean Arnold of Emory University School of Law challenged the Dorgan-Snowe bill as unconstitutional and contrary to international law. This...

The US government has embarked on a trade strategy to address alleged free riding by raising patented prescription drug prices abroad. This strategy is unwise and dangerous. It is likely to 'succeed' in low and middle income countries, desperate to sign a bilateral trade agreement with the US....