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The sky is not falling: FDA proposes common-sense treatment of generic drugs

There must be a global template for business complaints about regulation, located on some secret right-wing server. Just type in the industry and the name of the regulation: Billions of dollars are at stake, companies will be driven out of the industry and consumers will lose access to low-priced products, if the government dares to impose an ordinary, common-sense rule. Such as, making drug companies responsible for the safety of their products?

Aren’t pharmaceutical companies already responsible for warning their customers of known adverse effects? If you answered “yes, of course,” then you missed the Supreme Court’s 2011 ruling in Pliva v. Mensing. Currently, generic drug companies are required by the Food and Drug Administration (FDA) to use exactly the same labels and warnings as the corresponding brand-name drugs. Therefore, the Court ruled in Mensing, the producer of a generic drug cannot be held responsible for failure to warn customers of known hazards that are not mentioned on the brand-name drug label. This is particularly problematic in the frequent cases where generic drugs drive the brand-name producer out of the market, so that no one is updating the label to reflect new information.

 

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Monetization, Myopia, and MATS

The U.S. Supreme Court yesterday heard oral argument in the consolidated cases challenging the Environmental Protection Agency’s rule regulating mercury and other toxic emissions from coal- and oil-fired power plants.  These utilities remain by far the largest domestic source of mercury emissions, contributing more than half of the mercury releases nationwide.   Mercury emissions are at the root of widespread methylmercury contamination in the nation’s fish.  Fish consumption is the primary way by which humans are exposed to what is, after all, an “extremely poisonous neurotoxin,” as the attorney for those industries that joined EPA as respondent reminded the justices. [Transcript at 84]. The exchange captured by the transcript may not permit a confident prediction as to how the Court is likely to rule (an assessment shared by Lyle Denniston at SCOTUSblog ).  But it provides a glimpse of precisely how monetized costs and benefits can hijack deliberation.  Once dollar values are available, these numbers tend to dominate a discussion of what is at stake in regulation.  For mercury, the costs are readily quantified, whereas many facets of the benefits resist monetization.  So the case for regulation will not only get short shrift – it may be profoundly misunderstood.

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Carry the Zero: The Polluters’ Flawed Arithmetic in the EPA's Hazardous Air Pollution Rule

In the run-up to this morning’s oral arguments before the Supreme Court on the Environmental Protection Agency’s rule to limit hazardous air pollutants from fossil-fueled power plants—and indeed throughout the oral arguments themselves—opponents repeatedly pointed out that the benefits of the rule in reducing mercury pollution were “only” between $4 million and $6 million.  Putting aside the ethically problematic question of trying to put a dollars-and-cents value on achieving improved public health and environmental protection, it is worth pondering this number and what it reveals about the significant methodological flaws that are endemic to cost-benefit analysis.  (For the record, this number is supposed to represent the “value” of lost earning potential of children that the rule would protect against IQ point degradations.  Do you see what I mean about ethically problematic?)

Opponents of the rule claim that this $4-million figure is the only valid benefit estimation of the rule that the EPA should able to count in evaluating its mercury rule.  In making this argument, their real beef is that the EPA has also counted the co-benefits of the rule—that is, benefits that the rule achieves as an incidental byproduct of what is really trying to achieve.  In this case, EPA’s rule is meant to address mercury and other “hazardous” air pollutants, but along the way would significantly reduce particulate matter and ozone, which are classified as- “non-hazardous” air pollutants, but are still known by scientists to cause a host of environmental and public health problems.

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CPR's Tom McGarity Responds to Supreme Court's Examination of Costs Associated with Rule-making in Michigan v. EPA

Today, the Supreme Court heard oral argument in Michigan v. EPA

CPR Member Scholar and University of Texas School of Law professor Thomas O. McGarity responded to the debate with the following statement:

Following today’s oral arguments, the Supreme Court must decide whether EPA misinterpreted a section in the Clean Air Act requiring it to regulate hazardous emissions from power plants when such regulation is “appropriate and necessary.”  EPA interpreted those words to require the agency to focus on the harm that emissions of hazardous pollutants, like Mercury, can cause to human health and the environment, and not on how much it would cost industry to reduce those emissions.

EPA’s interpretation is fully consistent with the Clean Air Act’s precautionary approach to protecting public health and the environment from toxic emissions. 

History has proved time and again that if EPA must consider costs in deciding whether to regulate, industry advocates will dominate the deliberations with inflated cost projections, and the agency will never get around to protecting the public.

The statute makes it clear that cost considerations are relevant in determining the stringency of controls that EPA requires, but they are not relevant in deciding whether to regulate toxic emissions in the first place.

The Supreme Court has on many occasions over the past 30 years held that reviewing courts are to defer to EPA’s interpretations of the Clean Air Act so long as they are reasonable.

The Court should uphold EPA’s reasonable interpretation in this case.

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Today at the U.S. Supreme Court: Industry Tries to Shove a Cost-Shaped Peg Into a Benefit-Shaped Hole

When it comes to public safeguards, industry never wants to talk about keeping people healthy and protecting the environment; they’d much rather have a conversation about how safeguards will cut into their profits — the costs in the cost-benefit equation.  Even on matters where Congress, by statute, has made the discussion of regulatory costs legally irrelevant or a matter of only secondary importance, you can rest assured that industry will still be there talking exclusively about costs.  That is largely what is at issue in Michigan v. Environmental Protection Agencywhich is being argued today before the U.S. Supreme Court—another attempt by polluting industries to inject discussions of costs where they don’t belong.

But, for the EPA’s rule to limit mercury and other toxic pollutants from fossil-fueled power plants, the subject of the case, perhaps the most critical issue is the regulatory benefits at stake, and how the fulfillment of those benefits has been on a circuitous journey that is now extending into its 25th year. You read that right. It has been a quarter of a century since Congress first directed the EPA to issue this rule.  That’s when it passed the 1990 Clean Air Act Amendments.  As explained in a 2009 CPR white paper, the rule should have been completed by no later than 2000.  This ongoing delay has come at a huge price for the public health.  With every year that this rule has not been in effect, as many as 94,000 babies have been born in the United States with elevated blood mercury levels—levels high enough to leave them with irreversible brain damage—and as many as 231 children have suffered significant enough impairment of brain function to result in permanent mental retardation.

The fossil fuel industry no doubt wants to distract the public from contemplating the harmful health effects of its polluting activities; hence, it is trying to steer the conversation to regulatory costs in today’s case.  (The fact that these regulatory cost estimates are systematically overstated only provides them with further impetus on this score.)  It might be a useful PR move from their perspective, but it is not a legal requirement under the relevant provision of the 1990 Clean Air Act Amendments.  Let’s hope the Supreme Court will recognize this difference and reject industry’s abhorrent attempt to further delay this already long overdue safeguard for protecting our children’s health.

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Issue Alert: How to Hold Big Chicken Responsible for Pollution

In the United States, a handful of large corporations including Perdue and Tyson direct and oversee nearly every step in the poultry production process, essentially serving as overlords to the tens of thousands of small farmers with whom they contract to raise their chickens for slaughter. While deriving the lion’s share of the profit, these corporations have so far managed to avoid all responsibility for the pollution their chickens produce. The Environmental Protection Agency (EPA) and state agencies have been largely afraid to tackle the issue because of the well-heeled and politically powerful farm lobby. A new CPR Issue Alert urges government to hold these bad actors accountable and explains how to do so under existing law.

These companies, known as “integrators,” own virtually all aspects of poultry production—from hatching the chicks, to processing and retailing them, even transporting poultry products to grocery stores and restaurants. The integrators outsource the physical raising of the birds to contract growers but the contracts dictate the size of the flock, the temperature of the chicken houses, the ingredients of the feed, and the medication the chickens receive, among other minutiae. According to a North Carolina grower, his contract with Perdue explicitly prohibited him from exposing his chickens to sun or fresh air. Corporate representatives typically visit each producer and chicken house weekly to supervise the grower’s work. 

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CPR President Rena Steinzor in the Houston Chronicle: Criminal investigations crucial to making refineries safer

Last Friday marked the 10 year anniversary of the BP Texas City Refinery explosion that killed 15 people and injured 170 others.

In an opinion piece for the Houston Chronicle, CPR President Rena Steinzor describes the systemic failures which led to the explosion and the regulatory gaps that remain. She calls for criminal investigations, "everytime refinery operations kill, maim, or threaten public health."

She notes:

BP executive Ross Pillari blamed low-level workers for not "doing their jobs." Yet some of the men stationed at the tower had worked 12-hour shifts for 29 consecutive days, as required by BP policy. The company fired six of them, in effect reinforcing the perception that human error, as opposed to systemic mismanagement, was to blame. This spin was refuted by the evidence.

Several weeks before the explosion, Texas City plant manager Don Parus prepared a PowerPoint containing pictures of men killed in accidents on site and showed it to BP senior executives John Manzoni and Michael Hoffman. Parus had also commissioned a consulting firm to survey employees about safety. It reported that "[w]e have never seen a site where the notion, 'I could die today,' was so real."

Post-explosion reports by the Baker panel, the U.S. Chemical Safety Board, an internal BP review team, and investigative reporting by ProPublica and the Center for Public Integrity, ratified these fears.

To read the full piece, click here.

 

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OSHA Rejects Petition to Better Protect Poultry Workers

Last week, workers’ advocates at the Southern Poverty Law Center and Nebraska Appleseed got the official word that OSHA will not develop new regulations to protect the men and women who do the dirty work of turning clucking chickens into boneless cutlets. It’s an industry where vulnerable workers—mostly women, immigrants, and folks geographically isolated from other job opportunities—face great hazards from the strains of repetitive motion. Some of the plants process tens of thousands of birds on every shift, and a recent NIOSH review of one facility uncovered evidence of chronic musculoskeletal injuries in more than 40 percent of the workers who took part in the evaluation. The industry has a problem.

Lobbyists from the Chicken Council will proudly proclaim that the industry’s injury and illness rates have been dropping for years. But those numbers simply cannot be trusted. The chronic pain that workers suffer doesn’t always meet the definition of a reportable injury because it can be treated with first aid and doesn’t necessarily require time away from work. So even if you’re the kind of company that’s inclined to report accurately, risking elevated workers’ comp premiums, workers’ experiences of pain and suffering don’t match up with the numbers.

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CPR Senior Policy Analyst James Goodwin Testifies on Regulation for the House Committee on Small Business

Today, CPR Senior Policy Analyst James Goodwin will testify as an expert witness on the regulatory process for a House Committee on Small Business Hearing, "Tangled in Red Tape: New Challenges for Small Manufacturers.

Goodwin's testimony highlights the economic as well as public health and safety benefits of regulations in relation to small businesses. He notes:

Over the past four decades, U.S. regulatory agencies have achieved remarkable success in establishing safeguards that protect people and the environment against unreasonable risks. During the 1960s and 1970s, rivers caught fire, cars exploded on rear impact, workers breathing benzene contracted liver cancer, and chemical haze settled over the industrial zones of the nation's cities and towns. But today, the most visible manifestations of these threats are under control, millions of people have been protected from death and debilitating injury, and environmental degradation has been slowed and even reversed in some cases.

In short, the United States is much better off because of the regulations adopted over the past 40 years. But serious hazards remain, and indeed new ones continue to emerge as new technologies develop and the U.S. economy evolves. Americans would be even better protected if the gaps that leave them and their environment vulnerable to unnecessary risks were closed. To gauge the positive impact of regulation on Americans’ lives, consider:

  • The White House Office of Management and Budget (OMB) estimates that regulatory benefits exceed regulatory costs by about 8 to 1 for significant regulations.
     
  • The Environmental Protection Agency (EPA) estimates that the regulatory benefit of the Clean Air Act exceeds its costs by a 25-to-1 ratio.

The failure to regulate some hazards related to the workplace, the environment, product safety, food safety, and more, and the failure to enforce existing regulations on such hazards results in thousands of deaths, tens of thousands of injuries, and billions of dollars in economic damages every year. Sometimes, the damages are spectacular on a world-wide scale.

The BP Oil Spill caused tens of billions of dollars in damages.3 The Wall Street collapse may have caused trillions. Regulation to prevent catastrophe can be far cheaper, and less painful, than cleaning up damage to lives, property, and the environment later.

To read his full testimony click here.

 

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CPR Scholars Call on Senators to Enact Meaningful Reform of the Toxic Substances Control Act


What’s old is new again. This week, competing bills to reform the 40-year old Toxic Substances Control Act (TSCA) hit the Senate—one from Senators Vitter and Udall, the other from Senators Boxer and Markey. Both the environmental community and the chemical industry agree that TSCA is broken and must be fixed. This is a law that’s so poorly designed; EPA has been stymied in its efforts to ban asbestos. Yes, that asbestos. But where environmentalists and the chemical industry diverge is on the details of how to fix TSCA.

CPR Member Scholars and staff are still analyzing the bills, but one issue stands out as a fatal flaw in the Vitter-Udall proposal, and is addressed wisely in the Boxer-Markey proposal: the proposed safety standard. The “safety standard” is the focal point of the legislation: EPA’s central task under both proposals is to determine whether chemicals meet the standard. If a chemical meets the standard, then restrictions on manufacture, processing, and use will be limited. If it doesn’t, then EPA must consider tight controls, even banning the chemical. But the safety standard in this legislation is very problematic.

With colleagues from the environmental community, one dozen CPR Member Scholars sent this letter to the Chairman and Ranking Member of the Senate EPW Committee to explain our concerns. Chief among them is that the Vitter-Udall legislation retains a key phrase, “unreasonable risk,” that has been the Achilles Heel of EPA’s TSCA program for decades. If Congress intends to fix TSCA, the statute must be rid of that phrase and amended to use a standard that ensures a ‘reasonable certainty of no harm’ from chemicals in commerce. Such a standard—found in the Boxer-Markey bill—is better for both people and the environment.

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