The FDA Doubles Down On Its Plan B Troubles

by Lisa Heinzerling | May 29, 2013

Cross-posted on ACSBlog.

A panel of the Second Circuit Court of Appeals in New York has just taken under consideration the Food and Drug Administration’s motion for a stay of a district court order directing the agency to make levonorgestrel-based emergency contraceptives available to women and girls of any age without a prescription and without other point-of-sale restrictions. In deliberating on this motion, the panel of judges should not, I am sorry to say, take anything the FDA has said in its briefs at face value. The government’s opening and reply briefs on the motion to stay are so full of misstatements and omissions that the court could badly err if it did not take everything the government says with a shaker full of salt.

One of the factors in deciding whether to grant a stay pending appeal is the likelihood that the moving party will succeed on the merits. The government devotes most of its briefs to this factor. It makes two arguments as to why the court of appeals should find that the government is likely to win on appeal and should thus stay the district court’s order on emergency contraception. Both arguments depend crucially on incomplete and inaccurate renderings of the law and facts of the case.

Before turning to these arguments, a bit of context is necessary. The levonorgestrel-based emergency contraception at the center of this legal dispute takes two forms. One, Plan B and its generic versions, requires ...

Adapting to Climate Change: Seven Principles for Policy-Makers

by Jake Caldwell | May 29, 2013
The impacts of climate change do not fall equally. That is obvious on a global level, where low-lying countries, like Bangladesh and small island states, face inundation, while poor equatorial countries face devastating heat and droughts. It is less obvious, but still true, in the United States, where poor and marginalized communities without sufficient financial and social resources will face significant challenges adapting to the changing climate. While catastrophes appear to affect everyone equally, they are much harder on those who lack ...

What the White House Taketh Away, It Can Also Giveth: An Agenda for 'Regulatory Czar' Howard Shelanski's First 30 Days

by Rena Steinzor | May 23, 2013
As the scandal du jour over the pure lug-headedness of some IRS staffers reminds us, any screw-up, anywhere in the government, will make its way to the White House press briefing room in about a nanosecond of Internet real time. Suspicion is deeply bred into the press corps, and appropriately so. For that reason, the 2,000 or so people who directly serve on the President's White House staff, but who remain faceless to the rest of us, insist on maintaining control over ...

Dam Futures

by Dave Owen | May 23, 2013
Reposted from Environmental Law Prof Blog. A standard environmental history of American dams unfolds something like this: As a nation, we had a long love affair with dams.  And while they helped our nation grow into an industrial power, the environmental side-effects were immense: lost forests and farmland, drowned canyons, and, perhaps most importantly, devastated fisheries.  Yet even after some of those consequences became apparent, the story goes, dam-building marched on, powered by bureaucratic inertia and the seemingly unstoppable engine ...

What’s holding up the Clean Water Act jurisdictional guidance?

by Holly Doremus | May 20, 2013
Reposted from LegalPlanet. People on both sides of the political spectrum agree that the boundaries of federal jurisdiction under the Clean Water Act are murky, to say the least. But efforts by EPA and the Corps of Engineers to clarify those boundaries have been tied up in the White House for more than a year, with no explanation and to no apparent useful purpose. The President is fond of telling that nation that it should place more trust in government. ...

WARNING: Individual Research Findings and Economic Models May Not Be Fully Grounded

by Daniel Farber | May 15, 2013
Reposted from Legal Planet. A couple of weeks ago, a major paper on the economics of government deficits turned out to have huge flaws. Matt Kahn and Jonathan Zasloff have already had something to say about this, but I’d like to add some thoughts about the implications for environmental issues.“Interesting,” you say, “But what does that have to do with the  environment?”   I see two big lessons.  The first lesson is about the danger of overreacting to a dramatic ...

Why is the White House Blocking Rules on Energy Efficiency?

by Lisa Heinzerling | May 10, 2013
Cross-posted at ACSBlog. “The easiest way to save money,” President Obama declared in his 2012 State of the Union address, “is to waste less energy.”  In his 2013 State of the Union address, President Obama took another step and issued “a new goal for America”: “let’s cut in half the energy wasted by our homes and businesses over the next twenty years.” The President also vowed that if Congress did not “act soon” to address climate change, he would “direct [his] ...

Senate Republicans' Boycott of McCarthy Vote: More Shameless Obstructionism

by Rena Steinzor | May 09, 2013
Today's move by Senate Republicans to boycott a committee confirmation vote on Gina McCarthy to lead the EPA is just another in a series of shameless tactics aimed at hampering the Environmental Protection Agency and preventing it from doing the people's business. The list includes endless filibusters; sequester cuts that make it harder to enforce existing laws; a host of attacks on specific environmental regulations under the Clean Air Act, Clean Water Act and other statutes addressing critical environmental issues; ...

Lisa Heinzerling Reflects on OIRA-EPA Relationship

by Matthew Freeman | May 08, 2013
CPR's Lisa Heinzerling has an article in the most recent issue of the Pace Environmental Law Review, Inside EPA: A Former Insider's Reflections on the Relationship between the Obama EPA and the Obama White House, in which she discusses the ways that the White House Office of Information and Regulatory Affairs (OIRA) under Cass Sustein exercised control over EPA's regulatory process. She writes that, using cost-benefit analysis as a point of access, OIRA departs considerably from the structure created by the executive ...

In Dallas Morning News Op-Ed, McGarity Examines Texas Legislature's Response to West, Texas, Disaster

by Matthew Freeman | May 06, 2013
Last week, CPR’s Tom McGarity had a column in the Christian Science Monitor, describing the ways that the political right’s war on regulation and enforcement helped contribute to the West, Texas, fertilizer plant explosion last month. Today, he’s got a separate piece in the Dallas Morning News (and this past Friday, it was in the Houston Chronicle) taking a look at the Texas legislature’s response to the disaster. In the piece, McGarity takes a state legislator to task for declaring ...

Large OSHA Fine for Poultry Processor Highlights Flaw in USDA Proposal to Revise Inspection System

by Matt Shudtz | May 03, 2013
Just days before The Washington Post's Kimberly Kindy published her eye-opening story of chemical showers in chicken processing plants and the untimely death of a federal food safety inspector, OSHA announced fines totaling $58,775 in a case involving a worker fatality at another chicken processing plant – this one in Canton, Georgia. According to OSHA's press release, the worker "became caught in an unguarded hopper while attempting to remove a piece of cardboard."  The agency does not typically release the full ...

Who Is Running OIRA?

by Lisa Heinzerling | April 30, 2013
Reposted from RegBlog. In his revealing new book about his nearly four years as President Barack Obama’s “regulatory czar,” Harvard Law School professor Cass Sunstein describes a striking moment:  “After I had been in the job for a few years, a Cabinet member showed up at my office and told my chief of staff, ‘I work for Cass Sunstein.’  Of course that wasn’t true – but still.”  But still, indeed.  Sunstein’s book, Simpler: The Future of Government, makes clear just ...

OIRA Nominee's Disappearing Affiliation with Industry Think Tank

by Rena Steinzor | April 30, 2013
See the UPDATE at the bottom of the page. Last Thursday, President Obama named Howard Shelanski as his new nominee for Administrator of the Office of Information and Regulatory Affairs (OIRA). As of that evening, Shelanski was listed on the website of the industry-funded, fiercely anti-regulatory Mercatus Center as an "expert" in its Technology Policy Program. OIRA has long operated as a regulatory chokepoint, stalling and weakening health and environmental safeguards at the behest of industry groups, and as I've written, ...

Tom McGarity Op-Ed in the Christian Science Monitor: Feeble Oversight in West, Texas, Was No Accident

by Matthew Freeman | April 29, 2013
CPR's Tom McGarity has an op-ed in this morning's Christian Science Monitor describing the regulatory environment in which that West, Texas, fertilizer plant came to have a large stockpile of explosive material while operating with little or no oversight from state or federal authorities. An April 17 explosion at the plant claimed at least 15 lives and destroyed several hundred homes. McGarity notes that Texas has no state program for occupational health and safety, so leaves such matters to the ...

Obama's Next Regulatory Czar

by Rena Steinzor | April 26, 2013
A few months ago, I urged the Obama Administration to view the nomination of a second-term Administrator of the Office of Information and Regulatory Affairs (OIRA) as an opportunity to fundamentally change the role that the office plays in the regulatory system. Dozens of important rules got stuck at OIRA in the year before the presidential elections and are still languishing. House Republicans continue their blistering and unsubstantiated attacks on the agencies, doing everything they can to cut their budgets ...

An Energy No-Brainer

by Daniel Farber | April 24, 2013
Reposted from Legal Planet, by permisison. There are a lot of things to disagree about in terms of energy policy.  One thing that ought to be common ground, as discussed in a Washington Post column, is increased research in energy R&D.  As this chart shows, federal support for energy R&D is smaller than it was under Ronald Reagan: The economic argument for supporting R&D is simple.  Private firms don’t have enough of an incentive to engage in basic research because ...

Blistering Comments on State's Draft Keystone XL Environmental Impact Statement

by Sandra Zellmer | April 23, 2013
Monday was the deadline for public comment on the State Department's draft Environmental Impact Statement (EIS) on the Keystone XL Pipeline. Mine, which I submitted with the support of two of my University of Nebraska colleagues, are here. The State Department had initially announced that it would take the unusual path of refusing to make all of the comments available to the public absent a Freedom of Information Act request, but after a storm of criticism, the Department has reversed ...

Death of a Statute: The Kiobel Ruling

by John Knox | April 19, 2013
On Wednesday, the Supreme Court ended a generation of human rights litigation in the United States by holding, in Kiobel v. Royal Dutch Petroleum, that the Alien Tort Statute (ATS) does not apply to actions occurring in foreign countries. The ATS allows plaintiffs to sue in federal courts for torts committed in violation of international law and, since 1980, plaintiffs have used it for claims of grave human rights violations, such as torture, crimes against humanity, extrajudicial killing, and even genocide, ...

Agency U-Turns

Farber | Jun 18, 2018 | Regulatory Policy

Laying Down the Law on Rule Delays

Heinzerling | Jun 14, 2018 | Regulatory Policy

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