Update on Generics, Labeling, and Liability

                           

I began this blog back in February of 2014 with two posts on the FDA’s proposed changes to the rules for generic labeling and the issue of potential liability of generic drug manufacturers for failing to strengthen their warnings when it would be appropriate to do so. Recent events related to generic labeling and liability warrant a brief update on the issue. In litigation over injuries allegedly attributable to Reglan and its generic form, metoclopramide, a New Jersey appellate court has ruled that generic manufacturers could be liable for failure to warn when they had failed to update the label for their drugs even after the brand name manufacturer had added a new warning.  In other words, the New Jersey court held that actions for failure to warn were not preempted under the rule in Pliva v. Mensing, because in Pliva the defendants were required to adhere to the brand name drug’s label and in the case of metoclopramide the problem was the failure of some generic manufacturers to update their labels when changes were made to the brand name label.   

The second development on this issue is the news that the FDA is postponing action to finalize the proposed rule.  The FDA’s postponement of its final action on the rule comes in the wake of an interview with Regulatory Focus in which Ralph Neas, the President of the Generic Pharmaceutical Manufacturers’ Association, said that the Association was readying a lawsuit if the FDA adopted the proposed rule. The FDA has only said that it had received a very large number of comments on the proposed rule and that the Agency is committed to giving all comments serious consideration. This issue remains a hot one and the recent change in the balance of power in Washington only raises the temperature further.   

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Profits, Ebola, and Biodefense-- Common Ground for the New Congress

In my post of November 6, 2014, I linked to an interesting BBC story that pointed out that pharmaceutical companies are highly profitable in comparison with other industries and that pharmaceutical companies generally spend more on marketing than on research and development (in the case of Pfizer 72% more and in the case of Novartis 47% more).  This is unfortunate, but inevitable when companies with very similar drugs and relatively little data that support a physician’s preference for one drug over another are fighting for market share.  At the same time, pharmaceutical companies are being criticized for their high prices and for their slow pace of investment in developing drugs and vaccines for Ebola.  The New York Times on October 24, 2014, provided extensive coverage of a number of Ebola issues, including a story on a vaccine that had shown great effectiveness in a primate study but then had gone undeveloped for ten years.  The New York Times story pinned the blame for the delay in development on the lack of a significant commercial market for the vaccine.  The Director-General of the World Health Organization (WHO), Dr. Margaret Chan, had this to say in her November 3^rd address to the WHO Regional Committee to Africa:

The second argument is this. Ebola emerged nearly four decades ago. Why are clinicians still empty-handed, with no vaccines and no cure?

Because Ebola has historically been confined to poor African nations. The R&D incentive is virtually non-existent. A profit-driven industry does not invest in products for markets that cannot pay. WHO has been trying to make this issue visible for ages. Now people can see for themselves.

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Interesting BBC News Story on Pharma Profit Margins and Marketing Expenditures

The story link is here.  As I have often said on the subjects of profits, companies charge prices calculated to maximize their profits.  And, as to the high marketing costs, when there isn't solid data to support a choice among similar drugs, marketing costs will inevitably rise.

Personalized Medicine Update

Personalized medicine uses an individual patient’s variations with respect to one or more biomarkers or combination of biomarkers to determine which is the most appropriate pharmaceutical or medical intervention.   Such biomarkers can be genetic variations or other variations.  In Mayo Collaborative Services v. Prometheus Laboratories (Mayo v. Prometheus) the “biomarker” was the level of the metabolite in a patient who had been given a thiopurine drug, and the Supreme Court held that a patent that taught how to adjust the drug dosage after measuring the metabolite was invalid as an attempt to patent a natural phenomenon.  After one of Myriad Genetics’ patent claims related to gene sequences used in its genetic test for breast cancer risk was similarly invalidated as a natural phenomenon or product of nature, the biotech and diagnostic industries were understandably concerned.  Personalized medicine is clearly a vitally important area for future healthcare and the extent to which the difficulty of obtaining intellectual property protection for pharmacogenomic testing or other personalized medicine assays could delay or undermine progress in the area is a question of great importance.  The North Carolina Journal of Law and Technology recently devoted a symposium to the question of the significance of the decision in the Myriad case and Chris Holman’s contribution to that symposium, in which he considers the potential impact of Mayo and Myriad on personalized medicine is particularly worth reading.