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...

After the compounding pharmacy disaster at New England Compounding Center, Congress had an opportunity to assure that all compounded medicines were safe and effective. The Drug Quality and Safety Act, despite its name, fell short of that mark

Securing access to effective antimicrobials is one of the greatest challenges today. Until now, efforts to address this issue have been isolated and uncoordinated, with little focus on sustainable and international solutions. Global collective action is necessary to improve access to life-saving...

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...

The problem of antimicrobial resistance has led some infectious disease experts and their professional societies to propose the use of transferable intellectual property rights (wildcard patents) and patent term extensions as methods to encourage antimicrobial Ramp;D. We evaluate recent...

The Health Impact Fund (Hollis & Pogge 2008) is an innovative financing mechanism for global drug discovery and dissemination, separating the reward for successful R&D from the market price of the drug, also known as de-linkage. Aaron Kesselheim and Kevin Outterson have recently proposed a...

Two federal judges now tell us that the federal health law's individual mandate is unconstitutional. Three others disagree, and soon we will start to hear from appellate courts. But what if we put the legal arguments aside for the moment and focus on the real question: what happens to health...

Concerns about a dearth of antibiotic innovation have spurred calls for incentives to speed the development of new antibiotics. Our data demonstrates that many of the new molecular entity (NME) antibiotics introduced in the last 3 decades were withdrawn from the market, at more than triple the...

Despite the life-saving ability of antibiotics and their importance as a key enabler of all of modern health care, their effectiveness is now threatened by a rising tide of resistance. Unfortunately, the antibiotic pipeline does not match health needs because of challenges in discovery and...