Addressing the epidemic of high drug prices; Harvard Law Today, January 5, 2024

Jeff Neal, Harvard Law Today; Addressing the epidemic of high drug prices

"The Biden administration is once again targeting high drug prices paid by Americans. This time, officials are focused on prescription medications developed with federal tax dollars. The United States government, through the National Institutes of Health (NIH), awards billions of dollars of research grants to university scientists each year to fund biomedical research, which is often patented. The universities in turn grant exclusive licenses to companies to produce and sell the resulting drugs to patients in need. But what happens if a drug company fails to make a medication available, or sets its price so high that it is out of reach for a significant percentage of patients?

To tackle this problem, the Biden administration recently released a “proposed framework” that specifies when and how the NIH can “march in” and award the rights to produce a patented drug to a third party if the patent licensee does not make it available to the public on “reasonable terms.” The plan is based on a provision included in the Bayh-Dole Act, a 1980 federal law which was designed to stimulate innovation by encouraging universities to obtain and license patents for inventions resulting from federally funded research.

According to Harvard Law School intellectual property expert Ruth Okediji LL.M. ’91, S.J.D. ’96, although the Biden administration’s proposed framework for using government march-in rights to lower drug costs is an important development, whether it will be successfully implemented and result in meaningful drug price reductions remains to be seen. Harvard Law Today recently spoke to Okediji, the Jeremiah Smith, Jr. Professor of Law and faculty director of Global Access in Action(GAiA) at the Berkman Klein Center, about the new proposal and the legal challenges it might face."

The NIH and Moderna Are Fighting Over Who Owns Their Vaccine; Intelligencer, November 10, 2021

Matt Stieb, Intelligencer; The NIH and Moderna Are Fighting Over Who Owns Their Vaccine

"While last year the government was calling the shot the “NIH-Moderna COVID-19 vaccine,” the biotech giant filed a patent made public this week in which it found that “only Moderna’s scientists” designed the vaccine. The patent, filed in July, is specific to the genetic sequence creating spike proteins, which allow vaccine recipients to build antibodies to block the virus when the body is actually exposed. As the New York Times reports, the NIH was surprised by the attempt at a solo effort. If the two parties cannot figure out a way to split the credit, the government will have to determine if it will take the expensive step of going to court. Already, the U.S. has paid $10 billion in taxpayer funds for Moderna to help create the vaccine, test its efficacy, and provide shots for the federal government."

All of Us program wants to change the face of medicine; University of Pittsburgh: University Times, January 8, 2019

Susan Jones, University of Pittsburgh: University Times; All of Us program wants to change the face of medicine

"Dr. Steven Reis wants all of you to become part of All of Us.

Pitt received a $46 million award in 2016 from National Institutes of Health to build the partnerships and infrastructure needed to carry out the All of Us initiative, which seeks to gather health information from 1 million people nationwide to create a database to study different diseases and other maladies, and in the process change the face of medicine.

In Pennsylvania, Pitt is responsible for recruiting 120,000 participants and by early this week had reached 11,610. Nationally, there are more than a dozen other organizations now gathering participants and more than 80,000 people have enrolled nationwide. There are between 40 and 50 people working on the project at Pitt...

The institute “supports translational research, meaning how to get research from the bench to the bedside, to the patient, to practice, to the community, to health policy,” Reis said...

The information will be stored in a secure central database created by Vanderbilt University Medical Center, Verily Life Sciences (a Google company) and the Broad Institute in Cambridge, Mass. Volunteers will have access to their study results, along with summarized data from across the program."

Open-data contest unearths scientific gems — and controversy; Nature, March 8, 2017

Heidi Ledford, Nature; 

Open-data contest unearths scientific gems — and controversy

"Now one-third of the 60 papers that Wright's team had planned to publish are in jeopardy of being scooped. “I think the incentives to do these trials will be dramatically lessened if this is going to be the expectation going forward,” he says. “It's a huge time commitment.”

But others favour making data from trials publicly available as soon as possible. Doing so, they argue, opens up the possibility of a wide range of additional analysis, and speeds up analyses that can yield important clinical insights. “Clinical trial data are quite valuable, but usually they're kept locked away,” says Sandosh Padmanabhan, a participant in the competition who researches cardiovascular genomics at the University of Glasgow, UK. “Everybody who does clinical trials needs to open up their data for everybody to use.”"

Henrietta Lacks’s family wants compensation for her cells; Washington Post, February 14, 2017

Andrea K. McDaniels, Washington Post; Henrietta Lacks’s family wants compensation for her cells

"Francis Lanasa, the attorney who will represent the family, said that he would use a “continuing tort” argument, alleging that Hopkins had continued to violate the “personal rights, privacy and body parts” of Henrietta Lacks over time.

“They are literally the foundation of modern medical science,” Lanasa said of the cells."

The Institutional Animal Care and Use Committee; NIH, 2011

NIH; The Institutional Animal Care and Use Committee:

"Responsibilities

The IACUC is responsible for oversight of the animal care and use program and its components as described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and the Guide for the Care and Use of Laboratory Animals (Guide). Link to Non-U.S. Government Site - Click for Disclaimer Its oversight functions include an ongoing assessment of animal care and use. IACUC responsibilities include:

Review, at least semiannually, the institution's program for the humane care and use of animals;

Inspect, at least semiannually, the institution's animal facilities (including satellite facilities);

Prepare reports to the Institutional Official (IO) of the IACUC evaluations;

Review animal welfare concerns;

Make recommendations to the IO on any aspect of the animal program, facilities, or personnel training;

Review and approve, those components of PHS conducted or supported activities related to the care and use of animals;

Review and approve, proposed significant changes to the use of animals in ongoing activities; and

Be authorized to suspend an activity involving animals.

Membership

[Five People]The IACUC membership must consist of at least 5 members and includes:

one veterinarian with training or experience in laboratory animal science and medicine, who has direct or delegated authority and responsibility for activities involving animals at the institution;

one practicing scientist experienced in research with animals;

one member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, member of the clergy); and

one member who is not affiliated with the institution other than as a member of the IACUC."

Pitt faces animal rights scrutiny; Pittsburgh Post-Gazette, 3/2/14

Anya Sostek, Pittsburgh Post-Gazette; Pitt faces animal rights scrutiny:

"An animal rights group has filed a letter of complaint against the University of Pittsburgh, asking that the school be fined for violations against the federal Animal Welfare Act in its research labs.

The group, Stop Animal Exploitation Now, charges two rabbits died while being used in Pitt experiments and that there were several instances of primate escapes and other infractions, based on information Pitt voluntarily reported to the National Institutes of Health.

The group is asking the U.S. Department of Agriculture, which enforces the Animal Welfare Act, to fine Pitt $80,000 -- the maximum for what it counts as eight infractions.

Pitt acknowledges that "minor violations" occurred but said the violations already had been investigated by the NIH and that the agency did not find cause for further action."