Category Archives: Legal

Supreme Court Ruling Makes Generics More Dangerous

By Ben Comer | Published: June 23, 2011
Today’s Supreme Court ruling on Pliva v. Mensing, which held that generic drug companies are not responsible for updating drug labels in light of new safety concerns, makes taking generic drugs a riskier proposition for consumers, Justice Sonia Sotomayor wrote in her dissenting opinion. Justices Stephen Breyer, Elena Kagan and Ruth Bader Ginsburg also dissented [...]
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Bad Ad: One Year of Fear

By Ben Comer | Published: June 13, 2011
FDA’s Bad Ad program, launched in May of 2010, resulted in some 328 reports of potentially untruthful or misleading promotion, a handful of Warning Letters, and several Untitled Letters. But the single most effective tool in the Bad Ad program’s toolkit, according to Arnie Friede, principal at Arnold I. Friede & Associates, and a former associate [...]
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AstraZeneca Signs Exclusive Distribution Deal for Vandetanib

By Ben Comer | Published: April 27, 2011
As the number of drugs targeting small populations increases, managing numerous drug distribution channels and educating the relevant parties – specialty pharmacists, payers, physicians, and patients – becomes a daunting task. Specialty pharmacies that handle seven to 10 major disease states, after all, might only see three or four patients with a given rare disease, [...]
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How Will Accountable Care Organizations Hit Drug Sales?

By Ben Comer | Published: April 5, 2011
It’s not yet clear whether physicians will rush to form accountable care organizations (ACOs) in light of newly proposed Centers for Medicare and Medicaid Services (CMS) guidelines, which are lengthy, but pharmaceutical companies hoping to do business with ACOs will have to show that expensive brand drugs can offer not just better health outcomes, but [...]
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Federal Judge Declares Mandatory Health Insurance Unconstitutional

By Jennifer Ringler | Published: December 15, 2010
This new decision out of Virginia increases the prospect of a showdown between an elected Congress and President and the Supreme Court over the legality of this year’s health reform legislation affecting nearly one-fifth of the US economy. Resolution of the court case is unlikely before 2012—which is also an election year. Earlier this week, [...]
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