Members of Congress Seek NIH Hearing on Use of March-in Rights

    By Donald Zuhn --

On March 28, 2016, a dozen members of Congress sent a letter to Sylvia Mathews Burwell, the Secretary of the Department of Health and Human Services, and Dr. Francis Collins, the Director of the National Institutes of Health (NIH), to "strongly encourage the NIH to use its [march-in] authority to hold a public hearing on the request put forth by certain public interest groups to help establish whether or not [the statutory] criteria [for the use of the NIH's march-in rights] are met in the case of Xtandi (enzalutamide)."  Enzalutamide is a synthetic, non-steroidal pure antiandrogen that was developed by the pharmaceutical company Medivation for the treatment of metastatic castration-resistant prostate cancer.

The letter indicates that the drug was developed at the University of California, Los Angeles (UCLA) using taxpayer supported research grants from the U.S. Army and NIH, and that Japanese licensee Astellas currently "charg[es] Americans $129,000 for this drug, which sells in Japan and Sweden for $39,000, and in Canada for $30,000."  Noting that "[t]he 1980 Bayh-Dole Act gives federal agencies, including the NIH, the authority to license a patent when 'action is necessary to alleviate health or safety needs which are not reasonably satisfied' or if the invention is not 'available to the public on reasonable terms,'" the signatories to the letter state that "[w]e do not think that charging U.S. residents more than anyone else in the world meets the obligation to make the invention available to U.S. residents on reasonable terms."  The letter also notes that "despite [the Bayh-Dole Act] being in place for over 35 years, the NIH has never used this broad and powerful authority to protect consumers from excessive prescription drug prices."

According to the signatories, a "public hearing on Xtandi by the NIH would help to provide insight into NIH's decision-making process on this case," as well as allow the public "to better understand [the NIH's] position on the use of march-in to address excessive prices."  The letter points out that as a result of the NIH's granting of a hearing in 2004 on Abbott Laboratories' Norvir (ritonavir), the price of ritonavir was lowered for public payors.

The letter was signed by Representatives Lloyd Doggett (D-TX), Peter Welch (D-VT), Elijah E. Cummings (D-MD), Jan Schakowsky (D-IL), Rose DeLauro (D-CT), and Mark Pocan (D-WI), and Senators Bernard Sanders (I-VT), Al Franken (D-MN), Patrick Leahy (D-VT), Sheldon Whitehouse (D-RI), Elizabeth Warren (D-MA), and Amy Klobuchar (D-MN).

Comments

[Kwame Mensah]

What these representatives fail to understand is that rarely, if ever, is a drug "developed" at a University. Government funding for basic research that leads to a commercial entity taking the reins for late-stage development, clinical trials, and marketing is usually a drop in the bucket in the context of the total cost bore by the licensee company. Low drug pricing in other countries mainly is due to government regulations and subsidies that allow for it. If these legislators really want to help the public, they should sponsor legislation for government subsidies. Since when does a 15% contribution to the cost of something entitle you to full ownership? Never. Yet this is what these legislators are purporting. Totally disingenuous.

[EG]

Hey Don,

The continuing effort by certain members of Congress to improperly manipulate and coerce the NIH into exerting the "march-in-rights" provisions of Bayh-Dole as a means for drug price control.

[Dan Feigelson]

More populist b.s. for an election year. The active ingredient may have first been synthesized at UCLA as part of a research program funded with US government money (along with many other compounds, no doubt), but UCLA didn't "develop" the drug, no university has ever developed a drug. When's the last time a government anywhere, as opposed to a private company, developed a drug?

And how much are Japan and Sweden subsidizing enzalutamide and/or capping its price? Or the prices of drugs generally?

Not surprisingly, of the 12 people (out of 535 members of Congress) signed on the letter, you've got the entire Vermont Congressional delegation and both Minnesota senators.

If they're tired of the USA subsidizing drug development for the rest of the world, there are ways to address that directly and across the board. Trying to use NIH march-in rights in a single case isn't going to solve their problem.

[skeptical]

Merely a semi-serious musing...

Why bother with "'march-in" rights at all when one can attempt to use the "directed to" approach from the flavor of the day (101) to the legislated prohibition of "directed to" a human and find that all Pharma patents are void because they are "directed to" humans...

(This compare and contrast of what should be something narrowly applied - but not - in the judicial exception AND what should not be narrowly applied - and [currently] is - in the legislated writing; has not yet gained traction, but perhaps it "should," given the "logic" of how the "101 directed to" is being applied)