[Ip-health] Statnews (Pharmalot): Sanders, other lawmakers seek NIH hearing to override drug patent

Thiru Balasubramaniam thiru at keionline.org
Tue Mar 29 05:10:13 PDT 2016



Sanders, other lawmakers seek NIH hearing to override drug patent


Bernie Sanders wants a hearing on whether the NIH should override a
prostate cancer drug patent.

By ED SILVERMAN @Pharmalot

MARCH 28, 2016

Bernie Sanders and several other Democratic lawmakers are urging the Obama
administration to hold a public hearing to determine whether the National
Institutes of Health should override the patent on a prostate cancer drug.

The move comes two months after consumer advocacy groups asked the NIH to
override the price of Xtandi, because the medicine is much more expensive
in the United States than elsewhere. They asked the NIH to do so because
federally funded research was used to create the drug.

The medicine, which is sold by Astellas Pharma, has an average wholesale
price in the US of more than $129,000, about three to four times more than
what other high-income countries are paying, according to Union for
Affordable Cancer Treatment and Knowledge Ecology International, the
advocacy groups.

Obama administration rejects congressional push to override drug patents

The groups believe the Xtandi patent should be overridden because the drug
was developed at the University of California, Los Angeles, with help from
taxpayer dollars — specifically, NIH and US Department of Defense grants.
The university later licensed the drug to Medivation, a biotech that
eventually struck a marketing deal with Astellas.

“When Americans pay for research (which) results in a safe and effective
drug, an unreasonably high cost should not limit their access to it,” the
lawmakers wrote in a letter today to the US Department of Health and Human
Services Secretary Sylvia Burwell and to NIH Director Dr. Francis Collins.

“New treatments are meaningless if patients cannot afford them … (and) the
NIH has a powerful tool to hold drug companies accountable for barriers to
access to drugs developed through support of US taxpayers, including price.”

The lawmakers echoed the argument made by Union for Affordable Cancer
Treatment and Knowledge Ecology International: the NIH has the ability to
issue so-called march-in rights, which refers to overriding a patent.

Under federal law, this allows an agency that funds private research to
require a drug maker to license its patent to another party in order to
“alleviate health and safety needs which are not being reasonably
satisfied,” or when the benefits of a drug are not available on “reasonable

Whether the administration will comply is unclear.

Earlier this month, the administration rejected a request from dozens of
congressional Democrats, who urged the HHS and NIH to develop guidelines
that would require drug makers to license their patents and put a lid on
“price gouging.” They maintain the NIH should be more aggressive about
granting march-in rights when drug prices are high.

As we noted, Burwell responded to US Representative Lloyd Doggett (D-Texas)
— who was one of the dozen lawmakers who wants a hearing — that she does
not believe a new guidance for march-in rights is needed. She noted the law
is already clear about when the NIH can use its authority.

The NIH, she wrote, considers the use of a march-in right on a
“case-by-case basis and is prepared to use its authority” if the law
permits such a move and would “alleviate health or safety needs or address
a situation where effective steps are not being taken to achieve practical
application of the inventions.”

Burwell noted that the NIH had previously considered using its march-in
authority concerning drug pricing concerns in 2004 and 2013, but determined
the statutory requirements were not met. One of those episodes involved a
high-profile price hike on the Norvir AIDS medicine.

The lawmakers noted that the NIH held a hearing in 2004 to consider a
march-in request for Norvir, which at the time was marketed by Abbott
Laboratories. The company later lowered the price for public payers,
including AIDS Drug Assistance Programs and Medicaid, and expanded its
patient-assistance programs.

Taxpayer money helped create this cancer drug. Should we be able to force
the price down?

We asked the HHS and NIH for comment and will update you accordingly. We
also asked Astellas for a response and will pass along any reply. A
spokesman for Knowledge Ecology International, one of the advocacy groups,
told us the NIH had not yet responded to its request.

Among the lawmakers who signed the letter is US Representative Elijah
Cummings (D-Md.) who, along with Sanders, held hearings in late 2014 on
rising generic drug prices, and US Senator Amy Klobuchar (D-Minn.), who
last fall asked the Federal Trade Commission to investigate whether drug
makers are hiking prices, and then restricting distribution to prevent
generic drug makers from making lower-cost versions of their medicines.

Also signing the letter was US Senator Al Franken (D-Minn.) who earlier
this month introduced legislation that would end the tax break that drug
makers can take for advertising medicines to consumers. Another is US
Representative Rosa DeLauro (D-Conn.), who introduced a bill calling for a
three-year moratorium on advertising newly approved prescription drugs to

Ed Silverman can be reached at ed.silverman at statnews.com
Follow Ed on Twitter @Pharmalot

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