Lisa Heinzerling on CPRBlog {Bio}
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Tobacco Teachings, Up in Smoke?

Imagine a government warning on tobacco products that gave nearly equal prominence to both the pleasures and pains of using tobacco products. The "warning" would tell citizens that whether they should use tobacco products or not was – despite the government's long practice of recommending against such use – actually a pretty close case. Tobacco use is just so pleasurable, it turns out, that its risks – of bad health, of early death – might be worth it.Or imagine a parent saying the same thing to her child: here are the risks of using tobacco products, she'd say, but here on the other side are the wonderful pleasures. You make the call; it's too close for me to judge.

Despite its strangeness, this is exactly the kind of statement the White House and the Food and Drug Administration have collaborated in propounding in the 

context of a proposed rule deeming certain tobacco products subject to FDA regulation under the Family Smoking Prevention and Tobacco Control Act. Economists from the FDA and the White House's Office of Management and Budget published a study purporting to estimate the amount by which the health benefits of tobacco use reduction are offset by a loss of the pleasure of using such products. When the FDA's proposed rule on tobacco products went to the White House for review, White House economists, rather than placing this study in the dustbin where it belonged, doubled down on its strange analysis. Indeed, they ended up increasing the FDA's estimate of the extent to which the "lost pleasure" associated with reducing tobacco use offsets the health benefits to be gained.

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Secrecy protects only laggards: why the FDA should disclose which drug companies volunteer for its “judicious use” policy for livestock antibiotics

The Food and Drug Administration (FDA) recently recommitted itself to its lame proposal to address the profligate use of antibiotics in livestock by enlisting the voluntary participation of the drug companies that make the antibiotics.  Two documents issued last month reveal the details of the agency’s current plans.   The first is a final guidance document describing the FDA’s process for handling drug sponsors’ voluntary efforts to phase out “production uses” of antibiotics in animal feed and water and to bring the remaining uses under the oversight of a veterinarian. The second is a draft rule relaxing the requirements for veterinarians in exercising this oversight.  Production uses are aimed at promoting growth and improving feed efficiency, not at treating active infections.  The FDA will continue to allow mass medication of whole herds and flocks of livestock for purposes of preventing infection.

The FDA has, in internal documents, conceded that “all” of the relevant drug companies must participate in order to make its approach work.  But there is no guarantee that even a significant number of these companies will voluntarily give up production uses simply because the FDA asks them to.  Even if some do – Zoetis and Elanco have said they intend to – there is no guarantee that other companies will not step in to capture the market share given up by the volunteers.  And even if they do not – note the piling of hope upon hope required to believe the FDA’s policy might succeed – these companies will, under the FDA’s approach, still be allowed to feed antibiotics to whole herds and flocks of food-producing animals so long as they call it “disease prevention” rather than “growth promotion” or “feed efficiency.”  Not surprisingly, criticisms of the FDA’s proposal have been withering

Previous critiques of the FDA’s approach have, however, missed a key aspect of the agency’s approach, one that is both troubling and fixable: the near-complete opacity of the FDA’s program.  In its recent guidance document explaining its policy on livestock antibiotics, the FDA promises just three measures to keep the public apprised of its work.  First, the agency promises to post on its website a list of the drug products initially affected by its guidance document; the agency has already done this.  Second, the agency says that it will, after the three-month period in which drug sponsors are to inform the agency if they will take part in the agency’s voluntary initiative, “publish summary information to provide an indicator of the level of engagement of affected drug sponsors in the voluntary process.” Third, the FDA will notify the public “of completed changes to affected products through publication of approval of supplemental new drug applications” – or, in other words, it will tell the public when it has approved any drug companies’ requests to remove production uses from the list of indicated uses for their products.  

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Learning from the FDA's Plan B fiasco

In  2001, a group of private citizens, public health groups, and medical organizations petitioned the Food and Drug Administration (FDA) to approve nonprescription status for the emergency contraceptive Plan B and its generic cousins.  Under the Food, Drug, and Cosmetic Act, the FDA’s decision was supposed to turn on whether these drugs could be taken safely and efficaciously without the assistance of a licensed health professional.  Instead, an investigation by the Government Accountability Office (GAO) and fact-finding by the district court handling litigation over the controversy made clear that the FDA bowed to political pressure, first by delaying any decision as long it could and then by being as stingy as possible in granting nonprescription access to emergency contraceptives.

Over a twelve-year period, the agency resorted to extreme measures to avoid answering the statutorily dictated question: whether women and girls could safely and efficaciously take emergency contraceptives without permission from a licensed health professional.  With every new stratagem, the agency dug itself deeper into an administrative law hole: inventing policies on the fly, grasping at tangents, shrouding the truth, and cowering before illegitimate political demands.

No wonder that a district judge hearing a challenge to the FDA’s decision making finally had had it with the FDA’s shenanigans and ordered the agency to make emergency contraception available without restriction to all women and girls of child-bearing age. No wonder that the FDA was left with paltry legal arguments in its (now-abandoned) appeal of the trial court’s decision.  No wonder that the whole episode left observers inside and outside the agency shaking their heads over the sad retreat of a proud institution.

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The return of the senior death discount

The Food and Drug Administration recently announced its tentative determination that most of the trans fatty acids in our diets – specifically, partially hydrogenated oils (PHOs) – are not “generally recognized as safe” within the meaning of the Food, Drug, and Cosmetic Act, and thus must be regulated as food additives. If the FDA finalizes this determination, then food manufacturers would need to obtain the approval of the FDA before selling PHOs in any food or as food ingredients. Approval would then depend, in turn, on a determination by the FDA that PHOs were safe after all. In this way, a final determination by the FDA that PHOs are not “generally recognized as safe” would effectively amount to a ban on their use in food.

The FDA’s proposed finding is a huge deal for public health. The agency estimates that eliminating PHOs from the food supply could prevent as many as 7,000 fatal heart attacks each year, plus up to 20,000 nonfatal heart attacks. Numerous scientific studies and expert review panels have drawn a link between dietary intake of trans fatty acids, blood cholesterol levels, and coronary heart disease. Additional studies have found that consumption of trans fatty acids may have other adverse health effects as well, perhaps even including an increased risk of diabetes.

There will be plenty of scrutiny of the FDA’s proposal in the weeks to come. For now, I want to point out one aspect of the proposal that might not be obvious. Although the determination of whether PHOs are “generally recognized as safe” is a strictly scientific one, one that demands “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use,” the FDA nevertheless appended a cost-benefit report to its preliminary scientific finding. 

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Deeply flawed economic analysis exaggerates the cost of FDA’s produce rule

 One of the healthiest things a person can do is to eat lots of fruits and vegetables. Unless they’re contaminated with dangerous pathogens, that is. Contaminated produce has been responsible for an alarming number of deaths and illnesses in recent years, from Listeria-tainted cantaloupes that killed up to 43 people in 2011 to a Cyclospora outbreak linked to salad mix and cilantro that sickened 631 people in 25 states this past summer. 

For this reason, the Food Safety Modernization Act (FSMA) directed the Food and Drug Administration (FDA) to set standards to ensure the safety of the fruits and vegetables in our food supply.   The FDA’s proposed rule on produce safety would address some of the most likely sources of contamination on farms, including tools and equipment, water used in agricultural activities, and worker health and hygiene. At the Center for Progressive Reform we submitted comments to the FDA, urging the agency to issue the final produce rule as soon as possible, in its strongest, most protective form.

We focused most of our attention on the economic analysis that accompanied the FDA’s proposal. The FDA found that the rule is easily justified on economic grounds, estimating annual benefits of $1.04 billion—representing 1.75 million avoided illnesses in the United States—and annual domestic costs of $460 million.

But once we looked behind these numbers, it became clear that the rule’s benefits will be even more significant, and its costs considerably smaller, than the FDA suggests. The agency’s estimates are built on flawed assumptions, and those flaws were greatly exacerbated by the White House Office of Information and Regulatory Affairs (OIRA) during the 13 months that it spent marking up the proposal and delaying its release. By misrepresenting the rule’s impacts, these distortions help to fuel needless negativity towards the rule, from members of Congress, produce-industry associations, and farmers themselves. 

Below are some examples of how the analysis overestimates the rule’s costs. 

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20 Years of 12866

This coming Friday marks the 20th anniversary of a little-known but remarkably important document: Executive Order 12866, issued by President Bill Clinton in 1993. Executive Order 12866 replaced an order issued by President Ronald Reagan in 1981. Both of these documents set out a process whereby the White House – acting through the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) – would review major agency rules before they were issued.

Executive Order 12866, and the Reagan order before it, ushered in a new era in administrative law, one in which the White House would become the dominant force in administrative rulemaking and in which cost-benefit analysis would become the overarching framework for evaluating the wisdom of rules. Professional career staff in the agencies, steeped in the technical fields relevant to the agencies’ work, would see their work product changed, sometimes dramatically, by professional career staff in OIRA. Political management at the agencies would find their actions scrutinized, revised, and sometimes stopped altogether by political operatives at the White House. 

Even where statutes (as most do) charged a particular agency with making a particular technical finding and set forth a decision-making framework other than cost-benefit analysis, the White House process of regulatory review displaced those agency decision makers and supplanted the statutory standard with a cost-benefit test. The executive orders under both Reagan and Clinton qualified their reach by stating that they were to be applied “to the extent permitted by law,” but administrative law developments in the Supreme Court subsequent to the Reagan executive order – in particular, the famous Chevron decision – give tremendous leeway to agencies in interpreting the statutes they administer, and OIRA has taken upon itself to instruct agencies how to interpret these laws. Thus the constraint of following existing law is more illusory than real. 

Executive Order 12866 entered this fraught environment after over a decade of experience with Reagan’s order. Harsh criticism had followed the original order and its implementation. OIRA reviews took a long time; indeed, sometimes review never ended and rules simply died on the OIRA vine. The process was opaque. One could hardly tell what was under review, much less what OIRA had done during its review. OIRA review had become an opportunity for industry representatives to air their complaints about rules, and this part of the process was opaque as well. The same was said of the process for resolving a dispute between OIRA and the agency proposing an action. In short, in addition to worries about the substance of OIRA review, including the displacement of agency decision makers and the superimposition of a cost-benefit test on non-cost-benefit statutes, there were large concerns about the process as well.

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CPR's Heinzerling Reacts to President's Climate Change Speech

At a speech this afternoon at Georgetown University, President Obama outlined a series of aggressive steps aimed at curbing greenhouse gas emissions and preparing the nation to adapt to the now unavoidable effects of climate change. Center for Progressive Reform Member Scholar Lisa Heinzerling issued the following reaction:

The President’s speech offered exactly what many of us have been waiting to hear from him: A solid commitment to use the tools available to the EPA to finally get the federal government out of slow gear on climate change. In particular, by extending emissions limits to existing power plants, he’s taking dead aim at the most severe environmental problem facing the planet. Protests from industry and its allies on the Hill overlook an important reality: The Clean Air Act already gives the EPA authority to adopt such rules, and the Supreme Court has so ruled.

Heinzerling is a Professor of Law at Georgetown University. From January 2009 to July 2009, she served as Senior Climate Policy Counsel to the Administrator of the Environmental Protection Agency and then, from July 2009 to December 2010, she served as Associate Administrator of EPA’s Office of Policy. Before her EPA service, she was the lead author of the winning briefs in Massachusetts v. EPA, in which the Supreme Court held that the Clean Air Act gives EPA the authority to regulate carbon dioxide emissions.

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The Obama Administration’s Plan B for Plan B: Compliance, or Defiance?

The Obama Administration’s announcement that it will comply with a district court’s order that it make emergency contraceptives available to all women and girls without a prescription comes as a welcome development in a long-running administrative-law fiasco. But the Administration’s specific suggestions as to how it will set things right, set forth in letters sent yesterday to the district court and to the citizen petitioners who originally asked for nonprescription access to emergency contraceptives, are inadequate in several respects.

First, under the government’s approach, we will all have to wait for Teva Branded Pharmaceutical Products R&D, Inc. — the sponsor of the one-pill emergency contraceptive, Plan B One-Step — to submit a new application asking for full over-the-counter status for its product before anything can happen to implement the court’s ruling. The government’s letter to the court announcing its compliance with the court’s ruling, and its letter to the citizen petitioners announcing its granting of their petition, set forth no deadline within which Teva must submit a new application. For all we know, Teva is uninterested in submitting such an application. As the government revealed in the district court proceedings, 99 percent of Teva’s market is covered by the application the FDA approved in April of this year. Why should Teva want more? Perhaps it is satisfied with what it has. In any event, nothing in the government’s “acquiescence” requires any action at all from Teva, and thus the government’s actions are utterly dependent on the independent and unpredictable actions of a private entity. This alone should make the government’s proposed “compliance” with the court’s order unacceptable.

Second, in its letter to the court, the government says that the FDA has “invited” Teva to “promptly submit” a supplemental new drug application with proposed labeling that would permit Plan B One-Step to be sold without a prescription or other point-or-sale restrictions. But we don’t know exactly what the government’s letter to Teva says. A previous letter exchanged between the government and Teva, read aloud by the district court judge in a hearing on the government’s motion to stay his order, suggested that the FDA had asked Teva to submit only very limited studies in a new request for over-the-counter status for Plan B One-Step. The FDA’s new “invitation” to Teva could very well contain some such limitation. We don’t know; the government hasn’t made the letter public. It also hasn’t made the other letters exchanged between it and Teva public. Unless and until the letters are made public, we simply won’t know if any private deals have been struck between this public agency and this private company, and thus we will not know if the public interest is being adequately served.

Third, the government has not yet decided whether Teva will be granted marketing exclusivity for its product. The FDA had previously granted Teva three years of exclusivity based on its conclusion that the studies Teva submitted with its latest supplemental new drug application were “essential” to its approval of over-the-counter status for this drug for girls 15 and older. But the finding that these studies were “essential” itself conflicts with the district judge’s factual findings that Plan B One-Step was approvable for over-the-counter status without the new studies. The FDA has not directly challenged the district judge’s factual findings. Even so, the government’s letters to the district court and to the citizen petitioners indicate that the government continues to maintain that the latest studies on Plan B One-Step meaningfully distinguish this product from Plan B and its generic equivalents. Without a promise from the government that it will abandon its baseless assertion that the new Teva studies are “essential” in proving that Plan B One-Step is safe and effective for women and girls of all ages without a prescription, it appears that the government will continue to give legal effect to the very factual premises that the district court found arbitrary, capricious, unreasonable, and held in bad faith. This would not be compliance with the court’s order; it would be continuing defiance of it.

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EPA’s Formaldehyde Rule: The Mystery of the Shrinking Benefits

Why does the White House take so long to review rules from the regulatory agencies?  As I have documented elsewhere, many rules have been stuck at the White House’s Office of Information and Regulatory Affairs (OIRA) for years.  Some of these remain there to this day.  What is the White House doing for the months and years that rules are stuck there?

One rule that just escaped from the clutches of regulatory review might provide a clue.  Just yesterday, EPA posted documents generated as a result of White House review of its rule on formaldehyde emissions from wood products.  These documents show at least one possible answer to the question of why review takes so long: perhaps it takes a very long time to make the benefits of regulation disappear!  This, at least, appears to be a primary consequence of the more-than-year-long tenure of the formaldehyde rule at the White House’s OIRA.

EPA’s rule on formaldehyde emissions went to OIRA with an estimate of annual benefits that ranged from $91 million at the low end to $278 million at the high end.  The rule left OIRA, however, with an estimate of annual benefits that ranged from $9 million at the low end to $48 million at the high end.  (To see a chart showing this change, go here:!documentDetail;D=EPA-HQ-OPPT-2012-0018-0495 and click on document entitled “2013-05-20_Formaldehyde-Implementation_NPRM_EO12866-Documentation_3-Redlined-Draft EA-A4-table.”)  The low-end estimate of benefits, in other words, decreased more than ten-fold as a consequence of OIRA’s review, while the high-end estimate decreased more than five-fold.  What happened?  

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The FDA Doubles Down On Its Plan B Troubles

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 two pills. The other, Plan B One-Step and its generic versions, requires one pill. Both involve the same total dose of levonorgestrel. Despite these obvious similarities, the FDA has worked very hard to treat these drugs very differently; it has made Plan B One-Step available without a prescription to all women and girls over the age of 15, it has apparently blocked nonprescription market access to generic versions of Plan B One-Step for girls under 17, and it has resisted requests to make Plan B and its generic versions available without a prescription to girls under age 17. The district court’s order would make all of these drugs (except Plan B, which is no longer marketed) available without a prescription; the FDA would like to keep treating them differently.

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