The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: FDA approval

Pharma / Biotech R&D Budgets – A Proposal For Measuring Performance

During the BioFinance 2011 conference held in Toronto last week, one presenter showed a slide that outlined the number of new chemical entities (NCEs) approved by the FDA over a number of years. Since this slide was used in the context of the increase in global industry R&D budgets, it was meant to show that the huge increase in R&D budgets had not produced an appropriate increase in NCEs approved at the FDA. Is this the correct way in which R&D performance should be measured?

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No Preemption No Problem: State Courts Step Up

For anyone following the U.S. Supreme Court’s emerging case law on FDA approval and preemption (as we have been here, here, here, and here), it looks like the next frontier is going to be state law. With the Supreme Court’s ruling that drug manufacturers are subject to state tort claims even if they have undergone a full FDA review, liability depends on individual decisions by state legislatures and courts, which still have the power to exempt FDA approved drugs and 510(k) medical devices from tort liability in their states.

A recent decision by the Supreme Court of Arkansas has done just that. In DePriest v. AstraZeneca, the court dismissed claims brought under Arkansas’ Deceptive Trade Practices Act, holding that the Act contains a safe harbor that:

“specifically permits drug manufacturers to promote their drugs to consumers in a manner that is consistent with and supported by the labelling approved by the Food and Drug Administration.”

The court also dismissed the common law claims against the manufacturer on the grounds that FDA approval was sufficient to show that the manufacturer’s statements were not false or misleading.

Read the full opinion here (pdf).

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