Medicaid’s Best-Price Rule May Not Be Such a Big Problem

Physician's Weekly, October 23, 2017
Physician's Weekly, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, J.D., M.P.H., from Washington University in St. Louis, and colleagues discussed Medicaid’s “best-price rule” and the extent to which it might frustrate the goal of paying for value. According to the rule, a pharmaceutical…

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Allergan ruling casts doubt on tribal patent strategy

Reuters, October 17, 2017
Jan Wolfe, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: The company said the PTAB proceeding should be terminated because the tribunal did not have jurisdiction over the tribe. Allergan said it wanted to avoid defending the patent in both federal court and before PTAB. 

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One of Allergan’s blockbuster drugs was dealt a major legal blow

Business Insider, October 16, 2017
Lydia Ramsey, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Native American tribes, along with institutions like universities, have sovereign immunity that protects patents from certain challenges to their validity.  The tribe, in the Allergan press release, said…

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Judge invalidates Allergan patents and criticizes deal with the Mohawks

STAT, October 16, 2017
Ed Silverman, quoting Rachel E. Sachs

From the article: In a blow to Allergan (AGN), a federal judge invalidated the patents on its Restasis eye treatment, the latest twist in a captivating controversy over the fate of the best-selling medicine. The ruling brings some…

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Court Finds Restasis Patents Invalid, Raises Concerns About Allergan, Mohawk Tribe Agreement

RAPS, October 16, 2017
Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: In an 11-page order separate from the one invalidating the Restasis patents for obviousness, US Circuit Judge William Bryson wrote that the court "has serious concerns about the legitimacy of the tactic that Allergan and the Tribe have employed.…

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Ohio Issue 2 ballot initiative proponents overstate impact on EpiPen prices

Politifact, October 13, 2017
Manuela Tobias, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: In addition to the Medicaid program, the state purchases drugs for state employees, prisons, and other state-run programs, but the campaign was unable to pin down the effect of the initiative on these groups. Dennis Willard, a campaign spokesman,…

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Battle over drug prices shifts back to the states

The Hill, October 11, 2017
By Rachel Roubein, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: President Trump has derided pharmaceutical companies as “getting away with murder,” but there’s been little action in Washington to rein in the costs of prescription drugs. Some states are taking…

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Congress keeps the heat on 340B

Politico, October 10, 2017
By Sarah Karlin-Smith, citing work by Rachel E. Sachs (Academic Fellow Alumna)

From the article: The House Energy and Commerce Oversight Subcommittee will probe Wednesday into how hospitals and health clinics participating in the 340B discount drug program are using the savings they reap. Nonprofit hospitals and safety net providers…

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Organ Donor Research: Overcoming Challenges, Increasing Opportunities

JAMA, October 10, 2017
James F. Childress, reviewing report co-authored by I. Glenn Cohen (Faculty Director)

From the article: A substantial gap exists between the need for organ transplants and the number of transplants performed each year in the United States. In 2016, 27 630 organs were transplanted from 9971 deceased donors and 5980 additional organs from living…

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‘That should be illegal’: Lawmakers are taking aim at pharma giant Allergan over an unusual deal with a Native American tribe

Business Insider, October 10, 2017
By Lydia Ramsey, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Allergan, the drugmaker behind Botox, is using a tricky workaround to protect patents on one of its drugs — and lawmakers aren't exactly happy about it.  The deal, which passed off the patents for…

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ICER Weekly View 10-06-17

ICER, October 6, 2017
Mitchell Stein, featuring work by Rachel E. Sachs (Academic Fellow Alumna)

From the review: Medicaid’s “best price rule” has long been held up as an obstacle to value pricing – health policy/legal experts take a look and conclude that “the best-price rule is not as serious a problem as it is sometimes made…

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Axios Vitals post from October 4

Axios, October 4, 2017
By Sam Baker, featuring work by Rachel E. Sachs (Academic Fellow Alumna)

From the post: Medicaid and value-based drug deals: New research casts some doubt on the pharmaceutical industry's claim that Medicaid's "best-price" rule inhibits its ability to create contracts that pay for drugs based on…

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Letter to Allergan plc

The House of Representatives Committee on Oversight and Government Reform, October 3, 2017
By Trey Gowdy, Elijah E. Cummings, Dennis A. Ross, and Peter Welch, citing blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the letter: On September 8, 2017, your company announced the trans r of six patents related to its Restasis drug to the Saint Regis Mohawk tribe. 1 The unconventional maneuver has received considerable criticism om the generic competitors challenging the drug's…

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Absent federal action, states take the lead on curbing drug costs

The Washington Post, September 29, 2017
By Shefali Luthra, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Critics see these tailored efforts as falling short or potentially opening other loopholes. Requiring companies to report prices past a certain threshold, for example, might encourage them to consistently set prices just below that level. Maryland’s…

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Welcome to our 2017-2018 Student Fellows!

Petrie-Flom Center, September 14, 2017

The Petrie-Flom Center is pleased to welcome our new 2017-2018 Student Fellows! In the coming year, our fellows will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty…

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FDA Law SSRN Reading List - August 2017

Objective Intent Blog, September 14, 2017
By Erika Lietzan, highlighting work by Rachel E. Sachs (Academic Fellow Alumna)

From the post:  Rachel Sachs, Administering Health Information (forthcoming in Cardozo Law Review).  Professor Sachs (Washington University, in St. Louis) explores the potential…

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FDA Law SSRN Reading List - August 2017

Objective Intent Blog, September 14, 2017
Erika Lietzan, highlighting work by Rachel E. Sachs (Academic Fellow Alumna)

From the post:  Rachel Sachs, Administering Health Information (forthcoming in Cardozo Law Review).  Professor Sachs (Washington…

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The Latest Scam To Protect Sketchy Patents From Patent Office Review: Sell To Native Americans

Techdirt Blog, September 13, 2017
By Mike Masnick, citing Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] Being "self-reliant" means doing something of actual value yourself. It doesn't mean abusing an already questionable loophole in patent law to help giant pharma companies keep their dubious patents and limit the ability…

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Why a Drug Company Is Selling Patents to a Native American Tribe

Gizmodo, September 12, 2017
By Ryan F. Mandelbaum, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] There is concern that this act may be precedent setting, and other companies may also try and transfer patents to Native American tribes to get around these patent lawsuits. Rachel Sachs, a patent law professor at Washington University…

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Allergan’s deal with the Mohawks raises troubling questions about the future of generics

STAT , September 11, 2017
By Ed Silverman, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] Legal experts, however, say that tribal sovereignty may also thwart generic drug makers from filing a conventional lawsuit. If so, the ramifications may be far-reaching and ominous for consumers,…

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