FDA Should Broaden Use Of Real-World Data, Report Says - Law360

FDA Should Broaden Use Of Real-World Data, Report Says - Law360

By Emily Field

Law360, New York (June 24, 2016, 6:02 PM ET) -- The U.S. Food and Drug Administration should clear up how real-world evidence can be used in clinical trials and post-market surveillance for drugs and medical devices and consider expanded uses of such evidence in the agency's regulatory decision-making, according to a report released Thursday.

While using real-world evidence — such as electronic health records or data collected on wearable devices — is not prohibited by law in the FDA’s regulatory decision-making, so far the use has been limited, except in post-market monitoring and to support approvals for drugs to treat rare or life-threatening diseases, according to the report by the Bipartisan Policy Center.

The FDA does not routinely consider using real-world evidence for label expansion or new indications for drugs or to support new drug approvals, the report authors wrote.

“Sponsors and investigators would pursue the use of real-world evidence to augment and support clinical trials and post-marketing commitments if there were more clarity from the FDA regarding the types of real-world evidence that would be accepted for various decisions, and the methods required to establish confidence in analyses using real-world data,” the authors said.

The agency’s primary source of safety information is still the traditional adverse-event reporting from clinicians, patients and manufacturers, the report noted, while the use of EHRs by hospitals and doctors and consumers’ use of smartphone health and fitness tracking apps have surged.

EHRs and health apps are both sources of potentially useful health data that can complement data produced in controlled trials, the authors said.

The authors — which include former congressmen and FDA commissioners — said that the agency should develop formal guidance about the use of real-world evidence in its decision-making, including when it should be used and what types of data would be acceptable for use.

Pope Francis says the church should apologize to gays for helping to marginalize them | America Magazine

Pope Francis continues to try to change the attitudes the Church projects.  It is impossible to imagine that he would, like San Francisco Cardinal Cordileone demand that people in the employ of Church schools commit to the proposition that homosexuality is "intrinsically evil".
But the anti-discrimination clause in the Catechism is preceded by that statement that homosexuality is "intrinsically disordered".  The Catechism needs to change too. - gwc
Pope Francis says the church should apologize to gays for helping to marginalize them | America Magazine
Asked whether the church should say sorry to gays for the way it has marginalized them, as Cardinal Reinhard Marx said recently in Dublin, Francis responded in this way: “I say what I said on my first trip (from Rio), I say what the Catechism says: they must not be discriminated, they must be respected and accompanied pastorally.”

“I believe that the church should not only say sorry, as Cardinal Marx says, it should not only say sorry to the person who is gay that it has offended, but also it should say sorry to the poor and to women who are exploited, and the children who are exploited for work.”

He went on to explain that “When I say church I mean Christians. The church is holy but we are sinners. Christians must say sorry for not having accompanied them, for not having accompanied many choices, many families.” Indeed, “Christians must say sorry and not only for this. They must ask forgiveness, not just say sorry” and also ask God’s pardon. “It is a word that we forget a lot today,” he said.

Stanford sexual assault: public defenders support judge in open letter | US news | The Guardian

I haven't read the famous victim statement or the judge's sentencing statement,  But my instinct - as a former trial lawyer for the Public Defender in Newark - and opponent of mass incarceration is to side with the PD's here. - gwc
Stanford sexual assault: public defenders support judge in open letter | US news | The Guardian
by Nicky Wolf

A group of public defenders have come out in support of Aaron Persky, the judge facing a recall effort over his light sentencing of a former Stanford University swimmer who was convicted of sexually assaulting an unconscious woman.

The public defenders, led by Sajid Khan, stepped up to support Persky with an open letter and petition calling for judicial discretion that has, as of Friday afternoon, received nearly 300 signatures, most of which are from public defenders and defense attorneys.

Stanford sexual assault: records show judge's logic behind light sentence

Read more

The letter reads: “If judges had to fear direct, personal repercussions as a result of their decisions in individual cases, the rule of law would suffer.”

“Judge Persky applied the applicable laws, reviewed the right circumstances and factors that he was required to review, did not abuse his legal authority and utilized the discretion afforded to him to render a reasonable, fair sentence within the confines of the law and in line with the probation recommendation.”

Brexit Vote Results: Stunning Generational Divide in EU Referendum | BGR

Brexit Vote Results: Stunning Generational Divide in EU Referendum | BGR

Lilacs in bloom

 

Balkinization: Hunting Where the Ducks Are: Part II

Balkinization: Hunting Where the Ducks Are: Part II
By Mark Graber

Let's dispatch the affirmative action mismatch theory

The Supreme Court Has Upheld Affirmative Action. So Let’s Dump Mismatch Theory. http://nyti.ms/28TglV9

ACLU Opposes Use Of ‘Unfair Watchlist System’ To Enforce Gun Control

The ACLU opposes the modest Collins meaure to bar gun purchases by people on terroist watch lists.  This is one of the reasons I am not an ACLU person.  Their rule-bound approach to rights leads them to absolutist positions.  Since the Supreme Court in D.C. v. Heller has declared gun possession a fundamental right the ACLU takes the same absolutist position toward that "right" as it does to speech.  I dissent. - gwc
ACLU Opposes Use Of ‘Unfair Watchlist System’ To Enforce Gun Control

ByALLEGRA KIRKLAND Talking Points Memo JUNE 23, 2016

Democrats’ recent efforts to secure votes on gun control measures in the wake of the mass shooting in Orlando, Florida have stoked criticism not just from Republican leadership but from some on the left.

The American Civil Liberties Union on Wednesday sent a letter to senators laying out its opposition to the latest legislation up for consideration, a proposal by Sen. Susan Collins (R-ME) that would bar anyone on certain federal government watchlists from buying guns.
“The ACLU strongly urges you to vote against the Collins Amendment because it uses the errorprone and unfair watchlist system, along with vague and overbroad terms, as a predicate for a proceeding to deny a firearms permit,” ACLU legislative leaders wrote, saying reliance on the lists “would open the door to arbitrary and discriminatory government action.”

President Obama on the Tragic Shooting in Orlando | whitehouse.gov

President Obama on the Tragic Shooting in Orlando | whitehouse.gov

Judiciary Court Files Charges Against Alabama Chief Justice Roy Moore

Chief Justice Roy S. Moore

The Alabama Court of the Judiciary on May 7 filed a complaint against Chief Justice Roy Moore for obstruction of the duty of Probate Judges to comply with the order of a federal court.  Moore has been suspended with pay. Moore  was previously removed for defiance of an order to remove the Ten Commandments monument from the courthouse.  He was reelected.  
The Court of the Judiciary complaint relates to a January 6, 2016 Administrative Order by Moore which - after Obergefell v. Hodges - declared "Alabama probate judges have a ministerial duty not to issue any marriage license contrary to the Alabama Sanctity of Marriage Amendment or the Alabama Marriage Protection Act [which]remain[s] in force and effect."
The Court asserts six counts of violation of the Code of Judicial Conduct, including Canon 2A for failure to respect  and comply with the law".

Moore's Liberty Counsel defenders filed a federal action to enjoin the suspension. See complaint.

Garland's Credentials Bona Fide. Confirm HIm - Editorial Board - | New Jersey Law Journal

 

Garland's Credentials Bona Fide. We Reiterate: Grant a Hearing | New Jersey Law Journal

by the Editorial Board

Merrick Garland is everything that has been said about him: Harvard honors student, Supreme Court clerk, prosecutor of Timothy McVeigh, experienced judge of the center-left sort; praised by Sen. Orrin Hatch, Chief Justice John Roberts, and Gov. John Kasich, who has said that he would consider nominating Garland if he were president. Then-Judiciary Committee Chairman Hatch observed, of the 1997 Senate (76-23) confirmation of Garland's nomination to the U.S. Court of Appeals for the D.C. Circuit, that no one dared to come to the floor to speak against Garland.

Garland has deferred to the Executive branch in challenges to Guantanamo Bay, finding no jurisdiction in a detainee's challenge. He has described the constitutionality of capital punishment as "settled law". But in Saleh v. Titan Corp., he dissented, arguing that Iraqi victims of abuse at Abu Ghraib prison should be allowed to sue in tort the private U.S. government contractors whose personnel had savagely abused them. He has upheld EPA authority under the Clean Water Act, and often voted to affirm pro-employee rulings of the National Labor Relations Board.

Although the evidence of his qualifications is plain, Garland's nomination is burdened by the immediate reflex action of Senate Majority Leader Mitch McConnell that Barack Obama is not to have this pick. The U.S. Constitution, of course, provides that the president shall nominate, and with the advice and consent of the Senate, appoint the members of the Supreme Court. Though political hardball over judicial nominations is no party's monopoly, the Senate leader's refusal to even consider the president's nominee is without precedent.

We know that legal judgments are not mathematical deductions but often policy choices. And that when legislators and executives sharply disagree, the fights are bitter. But when judges are seen as politicians in robes, confidence in the judiciary suffers. Thus the refusal to hold hearings until after the presidential election will do damage to the courts if it is sustained.

So what then to make of the Garland nomination? In our view, Barack Obama has proposed an ideal "consensus" candidate. One who has garnered bipartisan support in the past. But we are confronted with a political environment too often characterized by opposition that is scornful of compromise and dismissive of the legitimacy of political opposition. Such a situation makes it nearly impossible for the political system to deal constructively with the country's challenges.

Merrick Garland is a judge whose record tells us that he models the kind of search for broad agreement that serves the courts and the country well. If the Senate continues to stonewall his nomination, it will embroil the Supreme Court in partisan combat that threatens confidence in the judiciary, as recent remarks by Chief Justice Roberts suggest. We join many others in urging the Senate to offer its advice and consent to the nomination of Judge Garland.

Rosemary Alito recused from this editorial.

Read more: http://www.njlawjournal.com/id=1202754734305/Garlands-Credentials-Bona-Fide-We-Reiterate-Grant-a-Hearing#ixzz4BmvtbJie 

President Oama's

Text of President Obamas speech in Hiroshima

Seventy-one years ago, on a bright cloudless morning, death fell from the sky and the world was changed. A flash of light and a wall of fire destroyed a city and demonstrated that mankind possessed the means to destroy itself.

Why do we come to this place, to Hiroshima? We come to ponder a terrible force unleashed in a not-so-distant past. We come to mourn the dead, including over 100,000 Japanese men, women and children, thousands of Koreans, a dozen Americans held prisoner.

Their souls speak to us. They ask us to look inward, to take stock of who we are and what we might become.

It is not the fact of war that sets Hiroshima apart. Artifacts tell us that violent conflict appeared with the very first man. Our early ancestors having learned to make blades from flint and spears from wood used these tools not just for hunting but against their own kind. On every continent, the history of civilization is filled with war, whether driven by scarcity of grain or hunger for gold, compelled by nationalist fervor or religious zeal. Empires have risen and fallen. Peoples have been subjugated and liberated. And at each juncture, innocents have suffered, a countless toll, their names forgotten by time.

The world war that reached its brutal end in Hiroshima and Nagasaki was fought among the wealthiest and most powerful of nations. Their civilizations had given the world great cities and magnificent art. Their thinkers had advanced ideas of justice and harmony and truth. And yet the war grew out of the same base instinct for domination or conquest that had caused conflicts among the simplest tribes, an old pattern amplified by new capabilities and without new constraints.

In the span of a few years, some 60 million people would die. Men, women, children, no different than us. Shot, beaten, marched, bombed, jailed, starved, gassed to death. There are many sites around the world that chronicle this war, memorials that tell stories of courage and heroism, graves and empty camps that echo of unspeakable depravity.

AMA calls Gun Violence a Major Public Health Crisis

http://thehill.com/policy/healthcare/283424-top-doctors-group-declares-gun-deaths-a-public-health-crisis

Balkinization: "Scholars Across the Political Spectrum"

Balkinization: "Scholars Across the Political Spectrum"
by  Mark Tushnet

... say that Donald Trump "shows contempt for ... the rule of law," according toAdam Liptak. As someone on Facebook pointed out (sorry, I lost the refe rence), all the quoted scholars are libertarians or libertarian-leaning (except for John Yoo, who is, I would say, an authoritarian). Still, Lipton's formulation is almost certainly correct. It literally goes without saying that standard liberals would endorse the view Liptak describes. So, Lipton's line doesn't mean that once one surveys libertarians, one has surveyed "the political spectrum."

I feel compelled to note that -- except for blatantly strategic reasons that I actually wouldn't find compelling -- I almost certainly wouldn't endorse the view that Trump shows contempt for the rule of law and the First Amendment -- not because I agree with his views, of course, but because "the rule of law" and "the First Amendment" are almost entirely without content, so that I don't know how someone could show contempt to "them" -- if there's no there there, I can't see how you could be contemptuous of "it." (Of course the claim that there's no there there is backed up by a fairly complicated argument not worth developing here -- an important component is that a reasonably well-socialized lawyer can mutter words showing that any proposition asserted to show contempt for the rule of law is actually consistent with the rule of law properly understood, and that those words are indistinguishable in principle from other words uncontroversially regarded as professionally respectable).

PrawfsBlawg: Conservatives and Criminal Justice Reform

PrawfsBlawg: Conservatives and Criminal Justice Reform

by David Fontana
Steven Teles wrote a wonderful book eight years ago about the conservative legal movement. This month he has published another book (with co-author David Dagan) about why many conservatives changed their mind about criminal justice issues.  For those interested in conservative legal and political thought, political and legal change, and/or criminal justice issues--or for those just looking for a great book to read--I highly commend this book.

Donald Trump’s Exploitation of Orlando - The New Yorker

Donald Trump’s Exploitation of Orlando - The New Yorker
by David Remnick

"Scholars Across the Political Spectrum" // tushnet // Balkinization

Balkinization: "Scholars Across the Political Spectrum"
by Mark Tushnet // Harvard Law School

Mark Tushnet

... say that Donald Trump "shows contempt for ... the rule of law," according to Adam Liptak. As someone on Facebook pointed out (sorry, I lost the reference), all the quoted scholars are libertarians or libertarian-leaning (except for John Yoo, who is, I would say, an authoritarian). Still, Lipton's formulation is almost certainly correct. It literally goes without saying that standard liberals would endorse the view Liptak describes. So, Lipton's line doesn't mean that once one surveys libertarians, one has surveyed "the political spectrum."

I feel compelled to note that -- except for blatantly strategic reasons that I actually wouldn't find compelling -- I almost certainly wouldn't endorse the view that Trump shows contempt for the rule of law and the First Amendment -- not because I agree with his views, of course, but because "the rule of law" and "the First Amendment" are almost entirely without content, so that I don't know how someone could show contempt to "them" -- if there's no there there, I can't see how you could be contemptuous of "it."

Chinese Common Law? Guiding Cases and Judicial Reform - Chinese Common Law? Guiding Cases and Judicial Reform

Chinese Common Law? Guiding Cases and Judicial Reform - Chinese Common Law? Guiding Cases and Judicial Reform 129 Harv. L. Rev. 2213 (2016)
by Mark Jia

Half a century ago, writing in this Review, Professor Jerome Cohen traced the “gradual abandonment” of the judicial-independence ideal in the early years of Chinese Communist Partyrule.^1×1. Jerome Alan Cohen,The Chinese Communist Party and “Judicial Independence”: 1949–1959, 82 Harv. L. Rev. 967, 967 (1969). Despite this trend, Cohen suggested, China’s leaders may in time “acquire a deeper appreciation of the virtues of functional specialization, professionalization, and judicial autonomy.”^2×2. Id. at 1006. A half century later, China’s judicial reform record is mixed. While the country has made considerable strides in building a more competent and professional judiciary,^3×3. See Stanley B. Lubman, Bird in a Cage: Legal Reform in China After Mao 251–97 (1999) (summarizing how China’s “judicial system has been extensively rebuilt since 1979,” id. at 251); see also Xin He,The Judiciary Pushes Back: Law, Power, and Politics in Chinese Courts, in Judicial Independence in China180 (Randall Peerenboom ed., 2010) (describing courts resisting party pressure); Benjamin L. Liebman, China’s Courts: Restricted Reform, 191 China Q. 620, 620 (2007) (pointing to areas of increased autonomy for Chinese courts). statist and populist forces have also deeply shaped the trajectory of reform.^4×4. See generallyBenjamin L. Liebman, A Return to Populist Legality? Historical Legacies and Legal Reform, in Mao’s Invisible Hand: The Political Foundations of Adaptive Governance in China165 (Sebastian Heilmann & Elizabeth J. Perry eds., 2011); Carl F. Minzner, China’s Turn Against Law, 59 Am. J. Comp. L. 935 (2011). Recent developments have further highlighted how China’s judicial (and legal) reforms have evinced a blend of professionalist, populist, and statist influences. While the Communist Party of China recently announced such “professionalist” reforms as reducing local interference with local courts, the Party has continued to emphasize its leading role in supervising the judiciary under a “socialist rule of law.”See Yang Yi, Highlights of Communique of 4th Plenary Session of CPC Central Committee,Xinhua (Oct. 23, 2014),http://news.xinhuanet.com/english/china/2014-10/23/c_133737957.htm[http://perma.cc/WE8A-2357].

This Note assesses a relatively recent innovation in China’s judicial reform project: the use of “guiding cases” to achieve greater adjudicative consistency across lower courts.^5×5. See infra Part I. Since 2010, China’s highest court has converted fifty-six judicial opinions into what are intended to be de facto binding decisions that courts “at all levels should refer to . . . when adjudicating similar cases.”^6×6. Zuigao Renmin Fayuan Guanyu Anli Zhidao Gongzuo de Guiding (最高人民法院关于案例指导工作的规定) [Provisions of the Supreme People’s Court Concerning Work on Case Guidance] (promulgated by the Adjudication Comm. of the Sup. People’s Ct., Nov. 15, 2010, issued Nov. 26, 2010) Beida Falü Xinxi Wang (北大法律信息网) [Chinalawinfo],http://www.pkulaw.cn/fulltext_form.aspx?Db=chl&Gid=143870[http://perma.cc/TNU5-792H], translated inStanford Law Sch., China Guiding Cases Project (2015),https://cgc.law.stanford.edu/wp-content/uploads/sites/2/2015/08/guiding-cases-rules-20101126-english.pdf[http://perma.cc/9PP9-S7QY] [hereinafter Provisions]. Figure is current as of May 8, 2016. Traversing subjects as wide-ranging as securities, land use, homicide, and graft, these guiding cases offer a potentially important new tool for the roughly 200,000 jurists charged with administering China’s legalsystem.^7×7. Cao Yin, Courts Court Change, China Daily(Aug. 13, 2014, 7:24 AM),http://www.chinadaily.com.cn/2014-08/13/content_18298352.htm[http://perma.cc/C3CC-789J]. Consistent with prevailing rules of citation, a Chinese author’s surname will appear in the order in which it appeared in the text of the publication.

Guiding cases have generated significant discussion among scholars and officials. Some proponents cite their potential to fill statutory lacunae, unify legal standards, improve judicial efficiency, and limit judicial discretion.^8×8. See Li Shichun (李仕春), Zhongguo Anli Zhidao Zhidu Kunju yu Chulu (中国案例指导制度困局与出路) [China’s Guiding Cases System: Dilemmas and Solutions], Zhongguo Renmin Daxue “Minshang Fa Qianyan” Luntan Yanjiang (中国人民大学“民商法前沿”论坛演讲) [Speech at the “Frontiers of Civil and Commercial Law” Forum at China’s Renmin University] (Mar. 5, 2009),http://old.civillaw.com.cn/article/default.asp?id=44157[http://perma.cc/XV8H-UYPN]. Others point generally toward returns to judicial flexibility,^9×9. See, e.g., Jinting Deng, A Functional Analysis of China’s Guiding Cases, 14China: Int’l J. (forthcoming Aug. 2016) (manuscript at 3),http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2381772[http://perma.cc/M945-H8P2] (arguing that “the guiding case system has equivalent functions to the Common Law in adapting law to social needs”). professionalism,^10×10. See, e.g., Björn Ahl,Retaining Judicial Professionalism: The New Guiding Cases Mechanism of the Supreme People’s Court, 217 China Q. 121, 123 (2014). and integrity.^11×11. See, e.g., Zhang Guangming (张光明), Zuigao Renmin Fayuan Fabu Disanpi Zhidaoxing Anli (最高人民法院发布第三批指导性案例) [The Supreme People’s Court Announced Third Batch of Guiding Cases], Zhongguo Fayuan Wang (中国法院网) [China Court] (Sept. 26, 2012, 9:22 AM),http://www.chinacourt.org/article/detail/2012/09/id/603873.shtml[http://perma.cc/L4RT-25UV] (pointing to the role guiding cases can play in “raising judicial integrity”).Meanwhile, less sanguine commentators have raised doubts as to China’s institutional readiness,^12×12. See Li Shichun,supra note 8 (summarizing the argument of Peking University Professor Fu Yulin). while others — even supporters — have focused attention on constitutional and political difficulties in the system’s design.^13×13. See infra text accompanying notes 53–60, 118–125.

Perhaps due to the elevated role of “case law” in many non-Chinese legal systems, analyses of guiding cases have often taken on a distinctly comparative flavor. Some have likened guiding cases to common law precedents, arguing that imbuing cases with “stare decisis–like authority”^14×14. Taisu Zhang, The Pragmatic Court: Reinterpreting the Supreme People’s Court of China, 25 Colum. J. Asian L. 1, 8 (2012). Professor Zhang himself does not make any claims of convergence, but his use of the term “stare decisis–like authority” is consonant with much of the rhetoric surrounding guiding cases. may bring China’s civil law system into closer alignment with the Anglo-American legal tradition.^15×15. See, e.g., Jinting Deng, The Guiding Case System in Mainland China, 10 Frontiers L. China 1, 1 (2015) (writing that “the current guiding case system and common law system have the tendency to become more and more similar systems in reality”); Seth Gurgel & Ping Yu, Stare Decisis in China? The Newly Enacted Guiding Case System, inReading the Legal Case: Cross-Currents Between Law and the Humanities 142, 156 (Marco Wan ed., 2012) (describing how the possible incorporation of case study into Chinese judicial education “would seem to presage increasing levels of formal common law–type jurisprudence in a system that already appears to have quite a bit of the informal variety”); cf. Jocelyn E.H. Limmer, China’s New “Common Law”: Using China’s Guiding Cases to Understand How to Do Business in the People’s Republic of China, 21 Willamette J. Int’l L. & Disp. Resol. 96, 133 (2013) (pointing to the “recognition of Chinese legal precedent”). Others have noted civil law analogs^16×16. See, e.g., Ninon Colneric, China Guiding Cases Project, Guiding by Cases in a Legal System Without Binding Precedent: The German Example 7 (2013),https://cgc.law.stanford.edu/wp-content/uploads/sites/2/2015/09/commentary-7-English.pdf[http://perma.cc/TJ5W-Y89M]. or sought to distinguish guiding cases as distinctively local.^17×17. See, e.g., Fang Wencui (房文翠), Jiejin Zhengyi Xunqiu Hexie: Anli Zhidao Zhidu de Fazhexue Zhiwei (接近正义寻求和谐: 案例指导制度的法哲学之维) [Approaching Justice Through Seeking Harmony: The Philosophical Dimension of the Guiding Cases System], Fazhi yu Shehui Fazhan(法治与社会发展) [The Rule of Law and Societal Development], no. 3, 2007, at 46, 46 (noting that guiding cases should not be wholly characterized as continental or common law “precedents”).

This Note aims to accomplish two goals in two parts. The first is to illume a clearer image of guiding cases and their contemplated role within China’s distinctive legal and political structure. The emerging portrait is that of a still-nascent system that has struggled to establish itself within China’s hierarchy of legal authority. Still, appreciable progress has been made. The second goal is to place guiding cases in comparative context, finding that despite widespread “common law” rhetoric, systems of this sort are hardly foreign to civil law. In fact, unqualified invocations of the common law can mislead more than they inform. The Note ends with parting thoughts on future reform.