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A new regulation proposed by the Food and Drug Administration will compel generic drug makers to update their labels to reflect “new” safety issues. This new rule is a poor tool for keeping generic drug labels up-to-date, and it will come at a significant cost to consumers. If public health is the true imperative for this change, the FDA can address the generic labeling issues in far better ways.
The reach of the Indian pharmaceutical industry is enormous. India supplies a large and increasing amount of the generic drugs sold globally, and the country is home to over 150 drug manufacturing facilities approved by the US Food and Drug Administration1—including many run by multinational players.
The basic challenge faced by medical products companies is that they’re trying to sell expensive products into an environment that’s increasing concerned about the cost of care, and in which key stakeholders are aggressively looking for opportunities to bring the costs down, and avoid unnecessary expenditures.
FDA and Congress are making great strides in improving the regulatory pathway and intellectual property protection for anti-infectives. But without changes in the reimbursement process, the package of incentives may not be enough to spur innovation in the class.
As drug companies take divergent strategies focused either on research or cutting costs, what might this mean for the path future companies take in the pharmaceutical industry?
High-profile technology companies are revered by society while pharmaceutical companies developing life-saving technologies are viewed with contempt; why the disparity?
The tragic deaths of 55 Americans and sickening of more than 740, resulting from contaminated steroid injections that were shipped by a disreputable firm in Massachusetts, have rightly focused public attention on a largely unfamiliar, but prominent part of our drug supply chain – the practice of pharmacy compounding.
We invite you to join us for two panel discussions on how Augustus created order from chaos 2,000 years ago, and what makes for durable domestic and international political systems in the 21st century.
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