King Amendment will KO Bayh-Dole

Political support for congressional curbs on abusive drug pricing is traditionally balanced by congressional R&D support to create innovative drugs to cope with new challenges like super bugs, new vaccines and older ailment cures for the likes of Alzheimer’s, cancer, and other presently incurable maladies. Moreover, the drug industry provides many US jobs and university related economic development. This duality balance is reflected in political issue manifestos released today by the leading Democrats Senator Schumer and Representative Pelosi. Each of their statements takes careful aim at abusive drug pricing but also reflects the need to preserve our globally significant economic and medical advantage in US drug development and manufacture.

Accordingly, the abusive conduct of “vulture capitalists” referenced in today’s NYT statement by Schumer is rebalanced by reference to “egregiously” raising the prices of lifesaving drugs “without justification.”

“Right now, there is nothing to stop vulture capitalists from egregiously raising the price of life-saving drugs without justification. We’re going to fight for rules to stop prescription drug price gouging and demand that drug companies justify price increases to the public. And we’re going to push for empowering Medicare to negotiate lower drug prices for older Americans.”

Similarly. Rep. Pelosi’s talking points stress putting “an end” to unjustified price gouging but allow for the transparent procedure to “justify cost increases.”

Aggressive action to lower the cost of prescription drugs – putting an end to outrageous and unjustified prescription drug price gouging, leveraging the power of Medicare to negotiate lower drug prices, and forcing drug manufacturers to open their books and justify cost increases.”

There certainly is a need to curb drug pricing abuse. But there is something familiar about recent and admittedly bad actor drug abuse and the DC practice of interests with unrelated objectives to exploit such abuse by pushing their agendas. We have experienced it before with the anti-patent originators’ use of their troll narrative. And while the drug issue is more politically compelling, the hijacking pattern is much the same. Like the infringer lobby’s efforts to dismantle our entire patent system presumably to curb patent trolls, the Bayh-Dole priced-based march-in lobby led by KEI’s Jamie Love is leveraging recent drug pricing abuse to convert B-D’s reasonable “availability” march-in language into congressionally unintended reasonable “pricing.” Having successfully persuaded Senator King to secure his march-in amendment after failing to pass one in the House, they are trying anywhere and everywhere else in DC to install price-based B-D march-in. Read on for a recent news item depicting Love’s distortions at the FDA.

James Love, director of Knowledge Ecology International, told the FDA panel “there should be more robust authority in the United States for a non-voluntary licensing of patents.” When asked by FDA’s Grail Sipes, director of the Office of Regulatory Policy, what compulsory licensing rules should be amended to grant FDA more authority, Love called for expanding Bayh-Dole march-in rights to “any drug, vaccine or medical device that’s regulated by the FDA.”

Universities avoid controversial congressional conflict wherever possible. And although US government price controls on drugs will add to the pervasive uncertainty now affecting the commercialization of life science discoveries and standing on the sidelines is dangerous is not unreasonable. But when the price abuse issue is squeezed into B-D by the price-based march-in lobby, universities must get involved because they are directly involved.

On this issue, we are not contending with tech titans. But TYT is under existential attack from a very capable anti- NIH and B-D Dole compulsory drug lobby who are persuasively sincere, but not only are wrong on their legal issue interpretation but are dangerously wrong on the consequences of their succeeding. Whatever temporary benefit emerges from surrendering US sovereignty over its markets and economy by ceding drug pricing to an amalgam of foreign free loaders, the adverse investment consequences are historically proven. If KEI’s Jamie Love succeeds, the new drugs, cures, and economic outcomes protected by today’s rhetorically balanced political objectives will be gone tomorrow. His ubiquitous DC anti B-D advocacy conduct can be effectively countered only with equally ubiquitous university home state advocacy with their House delegations.

Universities did not ask to become involved in NIH’s, BIO’s and PhRMA’s price fight. They have been dragged into it by price-based B-D march-in. This round of the drug price prize fight is a round research universities cannot afford to lose. The King amendment must not be allowed by your House delegations to remain in the final Defense Authorization Report. But unless you tell them it will knock you out of the life sciences commercialization ring. (If you haven’t yet, please see our two previous posts on this very serious issue.)

Leave a Reply

Your email address will not be published. Required fields are marked *