The Goose and the Elephant

Brian-KlepperAmerica’s drug and biotech industries are no doubt alarmed by the national firestorm that erupted when Turing Pharmaceuticals raised the price 55 times of its 62 year old lifesaving drug, daraprim. They must worry that CEO Martin Shkreli’s tone-deaf reactions to the public’s scorn could precipitate close scrutiny of broader drug industry dynamics. The last thing pharma wants is a vigorous, in-depth national discussion of pricing, value, what we can afford and how other advanced countries handle drug spending. All this could kill the golden goose.

Seeking distance from the furor, PhRMA tweeted that “Turing Pharma does not represent the values of PhRMA’s member companies.” Then BIO, the biotech industry’s association, rescinded Turing’s membership and returned its dues, the equivalent of booting Turing out of the country club.

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Lawyers and Medical Decision-Making

Merrill Goozner

First posted 6/28/11 on Gooz News

We’ve heard a lot over the years about the inappropriate role of lawyers in the medical system. The complaints usually center on trial lawyers who sue physicians for malpractice and drug companies for failure to warn consumers about unsafe drugs and devices. We’ve heard much less about lawyers who work for drug companies and try to game the regulatory system.

This latter problem was in full display this afternoon at the FDA hearing on Roche/Genentech’s appeal of the FDA’s decision to remove breast cancer from Avastin’s label.  Paul Schmidt, a Covington & Burling attorney representing Genentech, repeatedly tried to pin down FDA oncology drugs chief Richard Pazdur and his colleagues as to whether they had ever specified that replicating the progression free survival benefit seen in the first trial that led to accelerated approval would satisfy the FDA and therefore lead to permanent approval.

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