Hundred dollar bills rolled up in a pill bottle

Reasonable Pricing Clauses: A First Step Toward Ensuring Taxpayers a Fair Return on their Public R&D Investment

By Nikhil Chaudhry and Reshma Ramachandran

Earlier this month, the Department of Health and Human Services announced that it had successfully included a reasonable pricing provision in a $326M investment contract with Regeneron for development of a next generation monoclonal antibody therapy for COVID-19. This was the first time the Biden Administration had included such a provision as part of its research funding agreements with the private sector, demonstrating that it is indeed possible for the federal government to negotiate deals with pharmaceutical companies that ensure that products developed with public dollars are priced comparably to the global market.

Read More

Hundred dollar bills rolled up in a pill bottle

How Soon Could President Biden Enable Generic Competition to Xtandi? Very Quickly, If There Is the Will.

By James Love

On March 21, 2023, the NIH, acting on behalf of HHS Secretary Xavier Becerra, rejected a petition from four cancer patients asking HHS to use the government’s rights in the prostate cancer drug enzalutamide, in order to remedy pricing abuses by the patent holder. The abuse is charging U.S. cancer patients two to six times as much as other high income countries for Astellas’ and Pfizer’s Xtandi, a drug invented on federal grants.

The cancer patients could seek a remedy to the abusive and discriminatory pricing because the U.S. government had funded the R&D for each of the three patented inventions that are currently blocking generic competition.

Read More

BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

The NIH Has the Opportunity to Address Research Funding Disparities

By Leah Pierson

The Biden administration plans to greatly increase funding for the National Institutes of Health (NIH) in 2022, presenting the agency with new opportunities to better align research funding with public health needs.

The NIH has long been criticized for disproportionately devoting its research dollars to the study of conditions that affect a small and advantaged portion of the global population.

Read More

A stethoscope tied around a pile of cash, with a pill bottle nearby. The pill bottle has cash and pills inside.

What Ever Happened to NIH’s “Fair Pricing” Clause?

By Jorge L. Contreras

In the midst of the COVID-19 pandemic, calls have been made for “fair” and “reasonable” pricing of the vaccines and therapeutics that will eventually be approved to address the virus. A range of proposals in this regard have been made by members of Congress, the Trump Administration, various states, academics and civil society.

Amid this current debate, it is worth remembering the brief period from 1989 to 1995 when the U.S. National Institutes of Health (NIH) did impose reasonable pricing constraints on drugs that were developed as part of cooperative R&D agreements (“CRADAs”) between federal agencies and private industry.

Read More

Doctor or nurse wearing PPE, N95 mask, face shield and personal protective gown standing beside the car/road screening for Covid-19 virus, Nasal swab Test.

COVID-19 Highlights Need for Rights to Repair and Produce in Emergencies

By Joshua D. Sarnoff

In response to the COVID-19 pandemic, companies, organizations, and individuals have sought to address supply chain gaps for needed medical equipment. Spare parts and products created during the COVID-19 pandemic include ventilator tube splitters, nasopharyngeal swabs, and face shields.

In the past, outside of the context of a public health crisis, I have discussed the need to adopt legislation to create a narrow exemption from design patent liability to assure a competitive supply of automobile repair parts. The current pandemic makes a stronger case for the need to explicitly incorporate into our legal system a right to repair and supply products in emergencies.

Read More

Pipette and test tubes in a rack

Novartis, Dana Farber, Oregon Health & Science University Wait 18 Years to Disclose NIH Funding in Key Gleevec Patent

By James Love

This is a story about U.S. patent number 6,958,335, and how it took more than 18 years for Novartis to acknowledge National Institutes of Health (NIH) funding in a key patent for Gleevec, allowing Novartis to shape the narrative regarding its role in the development of Gleevec, and also to avoid demands that Novartis make the invention “available to the public on reasonable terms,” which is an obligation under the Bayh-Dole Act.

On May 10, 2001, the United States FDA approved a new drug, imatinib, initially for the treatment of a rare indication: chronic myeloid leukemia (CML). The drug was registered by Novartis, which sold the drug under the brand name Gleevec in the United States and several other markets, and as Glivec in others.

Read More

Government Shutdown: Why the Pipeline Matters

by Suzanne M. Rivera, Ph.D.

Much attention has been paid to the government shutdown that started last week.  Many of us heard heart-tugging stories on public radio about the NIH closing down new subject enrollment at its “House of Hope,” the clinical trial hospital on the NIH main campus.  These stories gave many people the impression that clinical research halted around the country when the federal government failed to approve a Continuing Resolution.

The reality is both less dramatic in the short term and more concerning for the long term.  For the most part, federally-funded projects at university campuses and hospitals are continuing as usual (or, the new “usual,” as reduced by sequestration), because the grants already awarded are like I.O.U.s from the government.  By and large, university researchers will keep spending on their funded grants, with the knowledge that reimbursement will come once the government re-opens for business. The universities and hospitals are, in a sense, acting like banks that loan the government money while waiting for these expenses to be reimbursed.

Also, many clinical trials are funded by the pharmaceutical industry.  So it is not the case that hospitals are closing their doors to research en masse.  But the long-term effects of a shutdown will have lasting and compounding effects on our science pipeline.  The U.S. federal government is the single largest funder of scientific research at American universities.  Each month, thousands of grant proposals are sent to the various federal funding agencies for consideration.  These in turn are filtered and assigned to peer review committees.  The whole process of review, scoring, and funding approval typically takes months, sometimes more than a year.

Under the terms of the shutdown, the staff who normally receive and triage these grant proposals are considered non-essential.  All but one of the federal grant on-line submission portals have been taken off-line.  So thousands of researchers who had been working for months to write grant proposals for funds needed to conduct the next generation of studies are now left wondering when it will be possible to submit for agency review.  Those studies hold the keys to future discoveries that could bring needed cures to the bedside, important products to the marketplace, and new jobs into the economy. Read More

More on NSF and NIH Funding

By Scott Burris

Here’s where some in Congress would like us to go:

ScienceInsider reports:

The new chair of the House of Representatives science committee has drafted a bill that, in effect, would replace peer review at the National Science Foundation (NSF) with a set of funding criteria chosen by Congress. For good measure, it would also set in motion a process to determine whether the same criteria should be adopted by every other federal science agency.

Whether or not you think of this as a partisan attack on science, it challenges the idea of science as an independent way of pursuing knowledge. The fact that this is even on the table, and could be taken seriously, shows how effective the attack on science has been.  It seems to reflect a terrible paradox:  on the one hand, social scientists are pissing some people off in a big way, which is a good sign we are doing something right in the inconvenient truth department; but on the other hand, I don’t see a lot of people rising to our defense, which suggest we matter to fewer people than we should.

This bill may or may not go anywhere, but anyone who cares about evidence-informed governance and the ability of the US to solve its problems ought to be concerned.

 

While We Sleep?

By Scott Burris

Nothing threatens a know-nothing more than the prospect of someone knowing something. Hence there has been increasing pressure on and from some in Congress to reduce government funding of social science research.  I hope every reader of this blog is aware that an appropriations rider added by Tom Coburn has drastically restricted NSF funding of political science research. That’s an ugly development, on par with the scandalous cuts to CDC that put paid to its gun research agenda years ago.

But the big funder of social and behavioral research in health is the NIH. In the past two weeks, I have heard via two different insiders that the agency is under pressure to significantly cut back on social and behavioral research, at least research with any important links to public policy. Now it is true that NIH does far too little policy-relevant research as it stands, but many fine researchers do important work related to law and policy with NIH support, and the important influence of law on health means we need more, not fewer, NIH-supported careers.

So I am hoping I am getting false information. What are you hearing?

Birth Control for Men?

By Dov Fox

We’re not talking vasectomies or condoms.

Medical Daily reports that the NIH has awarded a $4.7 million grant to come up with a “Pill” for men. Most previous attempts to develop such contraceptives used testosterone to reduce the number of sperm men produce. This one takes aim at its mobility instead, using a non-hormonal compound that promises fewer side effects, according to scientists. Clinical testing into its safety and efficacy, assuming the FDA grants permission, would take at least five to ten years before the agency could consider approving the drug for use.

The availability of male birth control would make it possible for men and women to share responsibility for contraception. Today, women alone shoulder the considerable physical and other burdens that come with the Pill. And only women enjoy the security that control of its use affords over the likelihood of unwanted pregnancy. Tomorrow, we could even things out a bit. That’d surely be a development worth embracing. Or would it? Sharing responsibility for contraception means leaving it to men to take the necessary measures to prevent the reproductive consequences that in our society fall far more heavily on women.

We might suppose that some such men, who have less at stake than their female partners, would be less vigilant about birth control and forget to take the pill. There is also evidence to suggest that other men might use greater control over conception for abusive purposes. A 2010 study found that 15% percent of respondents women ages 16-29 who sought care in several Northern California family planning clinics reported that their male partners had damaged condoms or otherwise sabotaged their birth control.*

Would birth control for men be cause for celebration, or concern? Would it revolutionize sexual equality, or change little at all?

*This “pregnancy coercion,” as the researchers call it, differs in respect of the gestation, abortion rights, and sex-differentiated social expectations involved from the reverse-gender cases that Glenn Cohen has analyzed in which courts “have imposed legal parenthood [] on fathers deceived into believing that their partners could not conceive” or under circumstances in which “conception took place without meaningful consent.”