If you’re harmed by an improperly labeled prescription drug you’ve taken, should your ability to hold the manufacturer accountable in court depend on whether that drug was “name brand” or “generic”? Strangely, it does matter, thanks to the 2011 U.S. Supreme Court decision in Pilva v. Mensing. There, the Court held that because of a quirk in the Food and Drug Administration’s (FDA) regulations, generic drug manufacturers were shielded against plaintiffs’ state tort law failure-to-warn claims that alleged that a generic drug’s labeling failed to provide adequate warning of particular health risks. The Court reasoned that since the FDA’s regulations didn’t readily allow generic drug manufacturers to update their labels quickly to warn consumers against any newly discovered risks, it would be impossible for those same generic drug manufacturers to fulfill a separate state tort law duty to provide such warnings through adequate labeling. The impossibility of complying with both legal duties simultaneously compelled the Court to find that the FDA’s regulations preempted the plaintiffs’ state tort law claims.
In the wake of that decision, the FDA has proposed to amend its regulations to eliminate this disparity. Specifically, the proposal seeks to extend to generic drug manufacturers the ability to use the “changes being effected” supplement process (often called “CBE changes”) to make changes to their product labels. It’s a little complicated, but the basic gist is that CBE changes enable drug manufacturers to update product labels relatively quickly whenever they become aware of certain kinds of information regarding the potential risks of their drugs. The goal of the CBE changes process is to empower drug manufacturers to provide consumers and their doctors with relevant risk information as quickly as possible, so that they can make the best-informed decisions possible about whether and how to take a particular drug. The public comment period for the proposal ends this Thursday, and CPR Member Scholars Tom McGarity and Sid Shapiro and I have submitted comments that aim to highlight for the FDA an important, but easily overlooked benefit of this rulemaking—namely, the invaluable role that a vibrant state civil justice system can play in complementing and reinforcing the FDA’s regulatory programs so that they are better able to protect the public against unreasonably dangerous drugs.Full text
Cue the majestic fanfare, for this week marks House Republicans’ so-called “Stop Government Abuse Week”—you know they mean business, because they have a clever Twitter hashtag and everything. So how does one celebrate such an auspicious occasion? Apparently, by wasting precious House floor time with a series of votes on several extreme anti-regulatory bills that, if enacted, would make it all but impossible for agencies to carry out their congressionally mandated missions of safeguarding the public against corporate abuses. The jewel in this potentially catastrophic crown is the Regulatory Accountability Act, which has been repackaged as Title II of the overstuffed “Regnibus” bill, officially known as the All Economic Regulations are Transparent (ALERT) Act (H.R. 2804).Full text
It’s time to put to bed an unfortunate myth that’s been floating around the last few weeks. The myth goes something like this: The Office of Information and Regulatory Affairs (OIRA)—the opaque bureau within the White House charged with approving agencies’ draft regulations before they can be released to the public—has succeeded in improving the timeliness of its reviews during the last few months. OIRA has long been a roadblock to the successful implementation of critical safeguards, so if true, this claim would be welcome news. But, when OIRA’s recent record is viewed with a more critical eye, this claim simply does not hold up.
While it’s true that OIRA has recently cleared its docket of several high profile draft rules that have been stuck there for several months or even years, in many cases OIRA has done so by relying on what almost amounts to an accounting trick—one that seems calculated to skirt any meaningful transparency requirements.
A few months ago, CPR noticed a disturbing trend in which OIRA was increasingly using an obscure and relatively uncommon process known as a “withdrawal” to end some long-overdue reviews of high profile draft rules. Among the first rules to be disposed of through this scheme included the Environmental Protection Agency’s (EPA) draft proposed Chemicals of Concern list (withdrawn from OIRA review on September 6, 2013, after 1,214 days) and the National Highway Traffic Safety Administration’s (NHTSA) draft final rule for rearview cameras in automobiles (withdrawn from OIRA on June 20, 2013, after 583 days).
So, what is a withdrawal and why does it matter? A withdrawal occurs when the rulemaking agency (for example, the EPA or NHTSA) voluntarily withdraws a draft rule from OIRA review before it has been completed. The withdrawal process is distinct from a “return,” which occurs when OIRA ends the review by sending the draft rule back to the rulemaking agency for more work instead of approving it. From a transparency perspective, there is a crucial difference between withdrawals and returns. When OIRA uses a return to end a review, Executive Order 12866 (a legal document that governs OIRA review) requires that it issue a public “return letter” that explains the problems with the draft rule and why OIRA was otherwise unable to approve it. In contrast, with a withdrawal, the rulemaking agency is under no obligation to offer a public explanation for why it decided to withdraw the draft rule from OIRA review.Full text
It’s like a Russian nesting doll of bad policy: House Republicans have contrived to take one of the most anti-science bills in memory and then place it inside one of the most anti-democratic legislative vehicles available. It’s part of an attempt to ram through into law new rulemaking requirements that would benefit the already-healthy bottom lines of their corporate benefactors at the devastating expense of the health, safety, pocketbooks, and perhaps even lives of the American public. That’s what is at stake with an obscure three-page rider—Section 12307, euphemistically entitled “Ensuring High Standards for Agency Use of Scientific Information”—in the 700-page House version of the Farm Bill (H.R. 2642, the Federal Agriculture Reform and Risk Management Act of 2013) that is currently undergoing conference committee consideration to resolve differences between it and the Senate version of the Farm Bill. (See page 654 of the bill for the rider—seriously, page 654!—which is available here; warning, this is a huge PDF.)
This anti-science rider began life as a stand-alone anti-science bill (also) euphemistically entitled the “Sound Science Act” (H.R. 1287), originally introduced by Rep. Stephen Fincher, a Tennessee Republican. If enacted, it would require all agencies (including independent agencies) to develop a conspicuously complex set of guidelines, which would purportedly improve agencies’ use of “science” in “policy decisions,” a term the rider defines very broadly to include virtually any type of agency activity, including non-legally binding guidance documents. The rider states that these policy decisions may not take effect unless they are in strict compliance with those guidelines. The rider appears to make this requirement judicially enforceable by declaring that policy decisions that fail to comply with an agency’s guidelines are “arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law.” (Because this section of the rider is so amateurishly drafted, it’s not entirely clear how this mechanism will work in practice. What is clear, though, is that if the rider becomes law, this section is sure to invite lots of costly, time-consuming, and wasteful litigation.)Full text
When it comes to OIRA’s antiregulatory meddling, the Federal Aviation Administration’s (FAA) pilot fatigue rule provides as textbook an example as you could ask for. Following Congress’s instruction that the rule be based on the best available science regarding human sleep patterns, the agency drafted a rule that set minimum rest standards for all commercial pilots. But, the rule couldn’t take effect without the White House’s Office of Information and Regulatory Affairs’ (OIRA) review and final approval. After more than four months, the rule that emerged from the OIRA review gauntlet had been significantly weakened. The minimum rest standards now applied only to commercial passengerpilots, while commercial cargo pilots were completely exempted. The change was based not on sleep science, as Congress mandated. What’s the justification? Fatigue generally affects all pilots the same, no matter what they happen to be hauling behind them. Against logic, OIRA justified the changes on the basis of an irrelevant, and arguably illegal, cost-benefit analysis: According to OIRA, the benefits of protecting cargo from fatigue-induced plane crashes, unlike the benefits of protecting passengers, simply did not justify the costs of abiding by the minimum rest standards. Not coincidentally, during the months-long review, a parade of cargo airline industry representatives marched through OIRA’s doors arguing for the change, relying on this very same cost-benefit analysis argument.
The story above is a familiar one, and most accounts of OIRA interference typically stop with the weakened and delayed final rule’s issuance. In reality, though, OIRA interference usually sets off a chain reaction of negative consequences—in the form of real harms to real people and to the effective functioning of our system of governance—that are worth taking a close look at. Indeed, the FAA’s pilot fatigue rule provides a glaring example of these negative consequences, as several recent developments have demonstrated.
Most dramatically, this past August a UPS cargo plane crashed while attempting an early morning landing at Birmingham–Shuttlesworth International Airport in Alabama, killing both crewmembers on board. In addition to the two fatalities, all of the cargo on the plane was destroyed in the crash, and some homes located near the airport were also allegedly damaged. The National Transportation Safety Board (NTSB) expects that its investigation into this incident will take several months to complete. At this point, however, the NTSB has found no evidence of mechanical failure and is now looking into whether the crash was a result of pilot error—including whether pilot fatigue was a contributing factor. The incident does provide a vivid illustration of what OIRA has put at stake with its meddling. It also provides a cautionary warning of the kinds of needless tragedies we can potentially expect if commercial cargo pilots remain exempted from the FAA’s minimum rest standards.Full text
Yesterday, the Environmental Protection Agency (EPA) announced that it was “withdrawing” from White House review its draft final guidance that sought to clarify the scope of the Clean Water Act. The guidance had been languishing at the Office of Information and Regulatory Affairs (OIRA), which oversees the White House regulatory review process, for 575 days, even though Executive Order 12866, the document that governs OIRA review of regulations, caps the length of reviews at 90 days plus a limited, one-time extension of 30 days. This is just the latest episode in what now appears to be a new disturbing trend: The Obama Administration seems to be increasingly relying on a relatively uncommon practice known as a “withdrawal” to unceremoniously dispose of long-overdue OIRA reviews involving important safeguards that are vigorously opposed by industry.
Over the last few months, several other industry-opposed rules have met a similar fate of being withdrawn after sitting at OIRA for well beyond the time limit permitted by Executive Order 12866:
·The National Highway Traffic Safety Administration’s (NHTSA) draft final rule mandating rearview cameras to prevent back-over accidents involving children: “Withdrawn” from regulatory review on June 20, 2013, after collecting dust at the OIRA for 583 days.
·The EPA’s draft proposed Chemicals of Concern list—an absurdly modest regulatory “action” that would have merely identified a handful of potentially harmful chemicals as worthy of additional agency scrutiny: “Withdrawn” from OIRA review on September 6, 2013, after an astonishing delay of 1214 days.
· The EPA’s draft proposal to limit the chemical industry’s specious “confidential business information” claims to shield crucial health and safety data on their new chemicals from public disclosure: “Withdrawn” from OIRA review on September 6, 2013 after 620 days.
Before delving into why this apparent uptick in withdrawals is cause for concern, some background may be in order. A “withdrawal” occurs when an agency voluntarily chooses to “withdraw” a draft proposed or final rule from the regulatory review process before OIRA, as the regulatory gatekeeper, has either formally approved the draft—clearing it for publication in the Federal Register—or denied it, through a “return letter,” sending the draft back to the agency for more work. At least, that’s the theory of how withdrawals work. In some cases, the circumstances suggest that OIRA or other White House officials have pressured the agency into withdrawing a rule.
The Executive Order does impose on OIRA important disclosure requirements that if followed, would help to bring needed transparency to the withdrawal process. Under the Order, these obligations are very broad, requiring OIRA to “make available to the public all documents exchanged between OIRA and the agency during the review by OIRA.” (Emphasis mine.) See for yourself at section 6(b)(4)(D). Presumably, included in “all” these “documents” would be evidence of flaws or policy disagreements that led the agency to withdraw the rule. It would also shed some light on whether this withdrawal was in fact voluntary or under pressure from the White House—and thus just a return letter by another name.Full text
Last week, Regulatory Czar Howard Shelanski embarked on his maiden voyage into the glamorous world of White House blogging, penning a post that touts the latest burden-reducing accomplishment of President Obama’s dubious regulatory “look-back” initiative. On this auspicious occasion, he trumpets the Department of Transportation’s (DOT) proposed rulemaking to reduce the number of inspection reports that commercial truck drivers have to file, resulting in reduced paperwork burden costs to the tune of $1.7 billion annually.
Shelanski makes clear in the post that this DOT rulemaking is not an isolated incident, but is in fact part of the regulatory look-back initiative’s broader antiregulatory project. He explains that the initiative is necessary because “some regulations that were well crafted when first issued can become unnecessary over time as conditions change—and regulations that aren’t providing real benefits to society need to be streamlined, modified, or repealed.” (Emphasis mine) In case the look-back’s antiregulatory objective wasn’t clear enough the first time around, Shelanski states emphatically at the end of the post: “This Administration will expand and further institutionalize our regulatory look-back efforts to ensure that we continue to identify rules that need to be modified, streamlined, or repealed.” (Emphasis mine again)
I’ve got a serious bone to pick with Shelansk’s three-part formulation of the look-back initiative’s goals (“streamline,” “modify,” “repeal”), and it’s this: The clear language of Executive Order 13563—which lays the initiative’s groundwork—reveals that Shelanski is deliberately overlooking a fourth stated goal—to “expand” existing rules where appropriate—which, not incidentally, is all that provides the look-back process with any semblance of balance. It’s right there in Section 6 of the order: “. . . agencies shall consider how best to promote retrospective analysis of rules that may be outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” (Emphasis mine yet again) See for yourself. I’ll wait.Full text
Tomorrow, a new panel in the Senate Judiciary Committee—the Subcommittee on Oversight, Federal Rights, and Agency Action—will bring some much-need sanity to the discussion of federal regulatory policy when it holds a hearing entitled “Justice Delayed: The Human Cost of Regulatory Paralysis.” What’s so refreshing about this hearing is that it starts from the premise that blocked and delayed safeguards are a problem that needs to be solved.
Crucially, this hearing will provide an opportunity to shine a light on the costs that are imposed on the public when regulations aimed at protecting people and the environment are unnecessarily delayed. These costs represent real harm to real people—and they are by definition preventable.
Previously, in this space, I examined the costs to the public that would result from the new delays to three rules that were announced in the Spring 2013 Regulatory Agenda. These included at least 300 premature deaths from the delay of the National Highway Traffic Safety Administration’s (NHTSA) Rearview Mirror Rule and at least 1,000 premature deaths and 1,467 non-fatal heart attacks that would result from the delay of the EPA’s updated ozone National Ambient Air Quality Standard (NAAQS). All of these costs are preventable, but not prevented.
Several of the scheduled witnesses for tomorrow’s Senate Judiciary hearing will help to provide a clear picture of what the costs of regulatory delay entail. CPR President Rena Steinzor will testify about how environmental regulations have benefited the public greatly, and how the continued delay of several pending safeguards—such as the Environmental Protection Agency’s (EPA) rules to control disposal of hazardous coal ash waste and to require cleaner-burning automobile fuel—produce great harm.
Tomorrow’s hearing is a welcome development, because when it comes to the issue of federal regulatory policy, sanity has been in short supply on Capitol Hill for the last four-plus years. And the timing of the hearing couldn’t be better, as it takes place during what House Republicans are calling “Stop Government Abuse Week,” a week dedicated to bashing public servants and voting on ill-conceived bills, including the REINS Act and the Energy Consumers Relief Act, which if passed, would make it all but impossible for the EPA and other agencies to carry out their congressionally mandated missions of safeguarding the public.Full text
Earlier this week, Regulatory Czar Howard Shelanski testified before the House Small Business committee to update committee members on the progress the Obama Administration has made with the regulatory look-back process established by Executive Orders 13563 and 13610. In one interesting exchange with Rep. Blaine Luetkemeyer (R-Mo.), Shelanski offered the following perspective on the Office of Information and Regulatory Affairs’ (OIRA) approach to regulatory review:
The interpretation of an agency’s statute and the choice of policy—to the extent there is discretion under that statute—is in the first instance in the province of the department or agency that is issuing the regulations. OIRA doesn’t set policy priorities or do the initial legal interpretations for the agencies. They do that.
(Skip ahead the 20:00-minute mark of the hearing.)
If true, this statement from Shelanski would represent a dramatic shift in how OIRA sees its role in the rulemaking process. For the past 30 years or so, OIRA has never been shy about trumping agencies on their policy priorities or their choices of policy. Indeed, just a few months before Shelanski took the helm there, OIRA blatantly interfered with the EPA’s rulemaking to update the effluent limitation guidelines (ELG) for power plants, as documented in a damning new report by several national environmental groups. The draft proposal that the EPA submitted to OIRA review contained several regulatory “options” for updating the ELG, and among those the EPA identified two of the stronger options—Option 3 and Option 4—as “preferred.” When the proposal emerged from OIRA more than three months later (following several meetings between OIRA and outside groups, including a number with corporate interests opposed to a strong standard), it had been drastically altered. (See the “redline” version showing all the changes that had been made here.) Among the changes, OIRA forced the EPA to include three new weaker options (Options 4a, 3a, and 3b). OIRA also forced the EPA drop Option 4 as a “preferred” option (this was the stronger of the two options that the EPA had initially preferred) and to instead designate all three of the new weaker options it added as “preferred.”Full text
“April showers bring May flowers.” To that well-known spring-related proverb one might soon add “the Spring Regulatory Agenda brings new groundless complaints from corporate interests and their anti-regulatory allies in Congress about so-called regulatory overreach.” Last Wednesday, the Obama Administration issued the 2013 edition of the Spring Regulatory Agenda, one of two documents the President must issue every year (the other is published in the fall) that compiles and summarizes the various regulatory actions that the Administration expects to take in the near future. Over the past few years, regulatory opponents have grown fond of pointing to the Spring and Fall Regulatory Agendas as still further evidence of the so-called “regulatory tsunami” that is allegedly hindering the economy and to support their campaign to “reform” our regulatory system. I expect that these same groups will waste little time in the coming days to misrepresent the latest regulatory agenda to bolster their attacks on our system of regulatory safeguards.
In fact, a careful comparison of one Regulatory Agenda to the next reveals just the opposite of what regulatory opponents claim: progress on needed safeguards has all but stalled, as new rules have become subject to new delay upon new delay. Rather than documenting a flurry rulemaking activity, the semiannual Regulatory Agenda has become more of a litany of the latest delays of and extensions to expected timelines for issuing proposals or final rules.Full text