Posts Tagged: "Francis Collins"

How much longer can there be no official announcement regarding the status of Michelle Lee? The continued silence raises very serious questions, particularly given that there have been public announcements made regarding others who have been specifically held over to serve in the Trump Administration. Undoubtedly, at some point continued silence about Lee’s status will mature into questions about her authority and whether any actions she takes are legal or perhaps simply void ab initio… If no answer is forthcoming in very short order someone will need to speak up, at least internally, because from the outside the facts give reason to suspect the possibility that a former USPTO Director may be refusing to relinquish power and the rest of the agency is just going along with it.

The problem with this theory is that the Bayh-Dole Act does not provide agencies the authority to regulate product prices. The law allows universities and contractors to own inventions made with federal funding so that they can be effectively commercialized. Congress included safeguards in case a dominant company licensed a breakthrough technology with the deliberate purpose of suppressing it, perhaps because it threatened an existing product. If good faith efforts are not being made to bring the invention to “practical application” so it is available on “reasonable terms” the funding agency can march in requiring that another company be licensed “upon terms that are reasonable under the circumstances.” Agencies can also march in if the developer is not able to produce enough product to meet public health or safety needs. In none of these situations is the government empowered to march in just because it doesn’t like a price.

Secretary Burwell and Director Collins are facing formidable pressure to reinterpret the Bayh-Dole Act for the compulsory licensing of costly drugs arising from federally supported research. And the pressure just increased another notch. On March 28, Senators Bernie Sanders, Elizabeth Warren, Al Franken, Patrick Leahy, Sheldon Whitehouse and Amy Klobuchar joined the leaders of the House Democratic Task Force on Prescription Drug Pricing urging Burwell and Collins to hold a meeting “to allow the public to engage in a dialogue with the Department of Health and Human Services and NIH in order to better understand its position on the use of march-in rights to address excessive prices.” If NIH joins in pursuing the swamp gas illusion that Bayh-Dole was intended to regulate drug pricing, we’ll quickly learn that it’s a lot easier getting into this morass than getting back out.

We’re in the business of transforming early stage, publicly funded research into useful products. The odds against success are long as commercialization requires years of hard work, a lot of money and some luck. We’d like to think that this effort is universally appreciated. Many in this profession ignore the public policy debates swirling around, thinking that no one will believe our critics or that someone else will defeat them. That’s a serious mistake.

The new year was hardly underway before Representative Lloyd Doggett (D-TX) and 50 of his House colleagues sent a letter to Health and Human Services Secretary Sylvia Burwell and NIH Director Francis Collins urging them to “march in” under the Bayh-Dole Act to control prices for drugs developed under the law. While the high cost of drugs is a legitimate concern, attempts to address the problem through technology transfer statutes would only guarantee that we will have fewer new drugs, not that they will be cheaper. The march-in provision is intended for instances when a licensee is not making good faith efforts to bring an invention to market or when national emergencies require that more product is needed than a licensee is capable of making, not to fix drug prices.