CDC Bows to Demands for Transparency and Public Input on Draft Opioid-Prescribing Guideline

cdc_logo(3)Over the past year, the Centers for Disease Control and Prevention (CDC) has been drafting a Guideline for Prescribing Opioids for Chronic Pain in relative secrecy, relying upon the input of a hand-picked group of advisers and a limited number of stakeholders. Such a stealth approach drew criticism from numerous interested parties, including Washington Legal Foundation, which explained in a November 17, 2015 letter to CDC that the agency’s drafting process ran afoul of the Federal Advisory Committee Act (FACA).

This week, CDC took several unexpected steps towards greater transparency for its prescribing guideline project, implicitly conceding its prior FACA violations. The director of CDC’s National Center for Injury Prevention and Control informed WLF on December 14 of its about-face in a letter responding to our November 17 missive. That same day, CDC published a notice in the Federal Register that seeks comments on the draft guideline and also directs the public to numerous previously-unreleased documents. In addition, CDC announced that it will ask a federal advisory committee, its Board of Scientific Counselors, to review the draft guideline and public comments and make recommendations to the agency. Continue reading

Advisory Committee’s Violations of Federal Law Threaten Credibility of 2015 Dietary Guidelines

MyPlateIn introducing an October 7, 2015 oversight hearing on the forthcoming 2015 Dietary Guidelines for Americans (DGA), House Agriculture Committee Chairman Michael Conaway stated, “It is essential that the guidance that comes out of this process can be trusted by the American people.” Chairman Conaway framed that remark in the context of the scientific evidence the 2015 Dietary Guidelines Advisory Committee (DGAC) relied upon in its Scientific Report. Lawmakers should question the quality of the report’s science, but their probe of the DGAC and its work shouldn’t stop there. Another, perhaps greater, threat to the Dietary Guidelines’ credibility is the significant breaches of federal law that occurred in the creation of the DGAC. Violations of the Federal Advisory Committee Act (FACA) infect the entire Scientific Report and call into question its recommendations and any federal regulatory proposals that rely on the report or the resulting DGA. Continue reading

Conflict Minerals and Pay Ratio: SEC Rules of Unintended Consequences

U_S_SEC_logoIn a highly influential 1936 essay, “The Unanticipated Consequences of Purposive Social Action,” sociologist Robert K. Merton explained that there were five sources of unintended consequences. One is the “imperious immediacy of interest:” someone wants the intended consequences of an action so badly that they consciously ignore any unintended effects. One can find many examples of this in government regulation. In fact, the Securities and Exchange Commission (SEC) provided an ideal illustration recently with its final rule that requires each listed company to express, in a ratio, how its workforce’s median pay compares with its CEO’s compensation. Continue reading

WLF Briefing to Examine Office of Management and Budget’s Role in Regulators’ Use of Science

PodiumPic1Science and Federal Regulation: Is the Office of Management and Budget an Effective Gatekeeper?

WLF Media Briefing, Tuesday, May 19, 10:00-11:00 a.m. EDT

Location: 2009 Massachusetts Avenue, NW (WLF headquarters)—RSVP to glammi@wlf.org or click HERE for free registration to view program live online

Speakers:

Federal Regulators’ Disregard for Sound Science Displayed in Four Agencies’ Actions

4th CircuitHow federal regulators use—and abuse—science in the regulatory process has a profound impact on regulated businesses and consumers who purchase their products and services.  In addition to the financial impact, every time that an agency forces science and the scientific process to serve its ideological or political agendas, rather than be guided by the neutral data, the public becomes less trusting of government pronouncements based on science. Below are some troubling recent examples of regulatory junk science. The first example demonstrates that protections against junk science do exist in the courtroom. The subsequent three examples reflect the lack of similar protections in the rulemaking and adjudication contexts.

Fourth and Sixth Circuits Slap-down EEOC. For the second time in less than a year, a federal appellate court has rebuked the Equal Employment Opportunity Commission (EEOC) for its use of junk science in accusing an employer of discrimination for conducting criminal background checks in its hiring process. EEOC’s litigation crusade against criminal background checks has faltered since its outset, with federal district court judges in Ohio and Maryland separately dismissing Title VII claims in 2013. Last April, just 20 days after hearing oral argument, the U.S. Court of Appeals for the Sixth Circuit affirmed the Ohio trial judge’s decision in EEOC v. Kaplan. The court found the EEOC’s statistical proof of disparate impact—compiled and presented by expert witness Kevin Murphy, an industrial psychologist—unreliable and “based on a homemade methodology” not generally accepted in the scientific community. A WLF Legal Opinion Letter and a WLF Legal Pulse post, both published last spring, offer more detail on the ruling. Continue reading

Federal Workplace Police Cast Aside Rules that Inhibit Capitalist Punishment

oshaNLRBAn excellent Economist article recently critiqued the ever-increasing criminalization of the American business community by federal regulators:

The formula is simple: find a large company that may (or may not) have done something wrong; threaten its managers with commercial ruin, preferably with criminal charges; force them to use their shareholders’ money to pay an enormous fine to drop the charges in a secret settlement (so nobody can check the details). Then repeat with another large company.

None of this is news to us here at WLF, where we have long been at the forefront of those who are concerned about the federal erosion of business civil liberties.

But what if, despite the heavy-handed leverage, government regulators still don’t get the results they are looking for? That’s easy—change the rules. That’s precisely what OSHA Administrator David Michael recently revealed he intends to do with the standard of proof required in whistleblower merits determinations.

Despite boasting to a recent meeting of the Whistleblower Protection Advisory Committee that, from 2009 to 2014, OSHA more than doubled the number of complaints it found to have merit, recovering over $119,000,000 in damages for whistleblower complainants in the process, Michael announced that OSHA will soon release a policy memo that will change the burden of proof in whistleblower investigations.

No longer will whistleblowers be required to prove by a preponderance of the evidence that it is “more likely than not” that a violation occurred. Rather, under the new regime, whistleblowers will need only establish “reasonable cause” that a violation occurred. That lower bar will undoubtedly result in many, many more cases being found to have merit by OSHA, which is what OSHA wants.

OSHA is not the only federal workplace cop pursuing rule changes on the fly to advance its ideological agenda. As explained in a new WLF Legal Backgrounder by Littler Mendelsohn LLP attorneys Michael Lotito and Missy Parry, the National Labor Relations Board (NLRB) is poised to radically alter long-standing definitions of who counts as an employer to favor unions, plaintiffs’ lawyers, and, of course, federal regulators.

Under the view of agencies like OSHA and NLRB, due process in the face of a government-decreed worthy goal is no virtue.  And drumhead justice in pursuit of that same goal is no vice.

Also published by Forbes.com at WLF’s contributor page

FDA Advisory Committee Not Rife with Conflicts of Interest? — “Please!” Quips Federal Judge

FDAIn order to achieve results that it believes are vital to public health, the Food and Drug Administration (FDA) has demonstrated time and again that it’s not afraid to trample laws and constitutional rights along the way. Occasionally, judges reintroduce FDA to the Rule of Law. We applaud one such recent rebuke by Judge Richard Leon, whose July 21 Lorillard v. FDA decision reminded FDA that it cannot stack a science advisory panel with members who will tell the agency what it wants to hear.

FDA tobacco control. After the U.S. Supreme Court rejected the agency’s attempt to seize regulatory oversight of tobacco products in 2000 (FDA v. Brown & Williamson), Congress granted FDA the authority it coveted in 2010. Banning or severely restricting the use of menthol in cigarettes has long been a goal of FDA’s friends in the anti-tobacco movement. FDA created a science advisory panel, the Tobacco Products Scientific Advisory Committee (TPSAC) to study menthol. The TPSAC concluded in 2011 that menthol had a negative effect on public health. Two companies filed suit in Febuary 2011, charging that FDA violated federal law by appointing members to the TPSAC who had clear conflicts of interest. The plaintiffs asked the court to strike the TPSAC’s report from the regulatory record.

Judge Leon’s opinion. The TPSAC members in question had ongoing contracts to testify as expert witnesses for plaintiffs in suits against tobacco companies. They also served as consultants to manufacturers of tobacco cessation products. FDA didn’t feel such relationships conflicted with their duties on the TPSAC. Judge Leon was quite flabbergasted by FDA’s decision. “Please!” he exclaimed, adding, “This conclusion defies common sense.” With regard to the members’ work with plaintiffs’ lawyers, Judge Leon explained that they had a financial incentive not to make any recommendations that would compromise the lawsuits in which they would testify. On the product consulting work, the judge noted that any FDA regulation of menthol would likely inspire more smokers to quit, potentially with the assistance of cessation products. Thus the TPSAC members also had a financial incentive to offer advice that would encourage a ban or restrictions on menthol. Judge Leon concluded that such blatant disregard for obvious conflicts violated federal law, and he enjoined FDA from utilizing the report in its assessment of menthol. Continue reading