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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A year ago, the Food and Drug Administration quietly posted a public notice that it wanted to hire an independent lab to test a generic drug that it had already approved. FDA wanted to make sure the drug was safe and effective.
Drug counterfeits can have extreme health consequences on the consumer; drugs with the wrong active ingredients can cause poor health outcomes and can create resistance to medication.
Pfizer's $100 billion offer for rival AstraZenecais proof that big drug makers are once again seeking out big mergers. It's a way for them to gain market leverage as governments clamp down on health-care spending. But the more interesting story—and one Big Pharma could learn from—is the bull market in young, lean biotech companies and their initial public offerings.
People may well compare car performance figures before buying, but I doubt many patients even think of doing so when it comes to medicines and drugs. The reason is that they trust the regulators (and their doctor) to ensure that all products work properly on the market. But why should a regulator of medicines be better than any other bureaucrat in any other field?
Biotech researchers and investors – to say nothing of the patients waiting desperately for new medicines – may conclude from the latest New Yorkerthat their problems are over.