Drug shortages, drug costs, the questionable quality of over-the-counter medicines: myriad issues have developed in pharmaceuticals in an era of enhanced regulatory efforts, rising healthcare costs and a global economy in which drug components are manufactured around the world. The new war on drugs is a policymaking battle in the legislative arena not over illicit back-alley dealing, but over cost, control and accessibility of the pills populating Americans' medicine cabinets.
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As busy as the digital health space has been lately, one group of stakeholders has been conspicuously absent from the proceedings: pharma companies. Shame on anyone who is surprised.
The FDA has issued a new regulation that could open generic drug makers to the same sort of product liability suits that plague branded pharmaceutical companies.
There is more that needs to be done when it comes to how FDA handles the development of drugs aimed at unmet needs. The fact is that a lot of the more significant FDA challenges aren't problems with regulation or statute. They are issues of culture.
If you like your medicines, you may not be able to keep them under Obamacare. The President famously promised that you could keep your health plan and doctor. For many people, both of those pledges are turning out not to be true.
At this event, Dinesh Thakur will discuss his experiences and the wider problems of Indian drug quality. Pharmaceutical and medical experts will then discuss Thakur’s remarks and the safety of US and international drugs.
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.