As CMS Considers Restricting Access to Pain Medication, Greater Opportunities for Public Input Are Required

CMSThe Centers for Medicare and Medicaid Services (CMS) is ramping up efforts to limit patients’ access to pain medication without giving affected parties sufficient notice or opportunity for comment.  Since the start of 2017, CMS has released three separate guidance documents on how insurers and payers should impose new limits on the use of opioids.  While opioid abuse undoubtedly presents a serious public health issue, CMS should take steps to foster transparency and avoid harming patients and providers alike by offering them a meaningful opportunity to participate in the development of policies that could limit pain management.  CMS also must do more to ensure that it adheres to statutes requiring complete openness whenever it solicits advice from advisory committees that include members who are not federal government employees.       Continue reading

EPA Uses “Sue and Settle” to Impose Regulations on Unsuspecting Industries

EPA-LogoIn recent years, EPA and other federal agencies have sought ways to circumvent the strictures of notice-and-comment rulemaking. One popular method became known as “sue and settle.”

Here’s how it works: An advocacy group files suit demanding that a federal agency impose new or stricter regulatory standards on a business or even an entire industry. Instead of defending, the agency accedes to the activist group’s demands, negotiates a private agreement, and then seeks court approval through the consent-decree process. Some consent decrees have arisen from lawsuits that demand an agency perform a nondiscretionary statutory mandate that it has failed to implement, while others call for entirely new uses of regulators’ discretionary authority. Sue-and-settle agreements frequently shorten the amount of time for public comment on the agency action arising from the settlement or curtail the time an agency has to review public comments before finalizing a rule. Continue reading

FEDERAL REGULATORY READING LIST: Resources for New Leaders at FCC

FCC*Note: This is the second in a planned series of posts compiling Washington Legal Foundation papers, briefs, regulatory comments, and blog commentaries relevant to critical legal and constitutional issues facing new senior leaders at specific federal regulatory agencies. To see the first post in the series, discussing DOL, OSHA, EEOC, and NLRB, click here.

Rapid technological change has altered the way people communicate and consume information.  For the past eight years, the Federal Communications Commission (FCC) has been scrambling to adapt to this new reality while expanding its regulatory turf.  In the process, FCC has cut corners and imposed new regulations that chill innovation and investment.

Through its public-interest litigation, publishing, and other advocacy, WLF influenced debates over FCC’s policies and actions with timely papers and blog commentaries, and weighed in directly through regulatory comments and amicus briefs.  Those activities have resulted in an impressive body of reference materials that are instructive for new leadership in the agency.  We provide a summary of and links to those documents below to simplify access to relevant work product from WLF in each of those areas. Continue reading

The Government Should Stop Using ‘Operation Choke Point’ to Bully Banks into Cutting Ties with Legitimate Businesses

imagezOn the eve of the inauguration, many industries and businesses await the changes a new administration will bring.  In particular, payday lenders are hoping that they will once again be able to enjoy unrestricted banking access, as for the past several years their banking relationships have slowly been severed as a result of a government initiative known as “Operation Choke Point.”

Operation Choke Point began—without any Congressional approval or even knowledge—as a product of President Obama’s 2009 executive order to eliminate fraudulent and illegal businesses.  Not surprisingly, however, the initiative quickly expanded.  By 2013, the Department of Justice (DOJ) had started quietly launching the now-infamous federal initiative unconstitutionally cutting off countless legitimate businesses from banking services. Continue reading

Should Pharmaceutical Manufacturers be Forced to Produce a Product Against Their Will?

5th-aAs the beginning of a new administration nears, politicians and pundits have been floating many ideas for regulating the cost and availability of pharmaceuticals and other medical treatments. One of the worst ideas being discussed is the judicial creation of a common-law duty to manufacture. Thankfully, there are significant Constitutional and judicial hurdles preventing this duty from materializing.

In order to develop and produce innovative, life-saving drugs, pharmaceutical manufacturers must go through incredibly expensive and time-consuming clinical trials required by the rigid guidelines of the Food and Drug Administration (FDA). As an incentive to go through this process, these companies receive patents to help them recoup the costs of the clinical trials. In some instances, however, even with market exclusivity, manufacturers are unwilling to continue producing these drugs, often because production ceases to be economically feasible. Continue reading

The New Era of “Daimler” Yields Confusion in the Lower Courts

bnsfPrior to the US Supreme Court’s 2014 decision in Daimler AG v. Bauman, general jurisdiction existed over a business defendant in any state where it was incorporated, had its principal place of business, or its contacts were so “continuous and systematic” as to render them essentially at home in the forum state.  Under this expansive interpretation, corporations could be subject to lawsuits in unpredictable and often remote jurisdictions.

Daimler significantly narrowed the reach of general jurisdiction by holding that because Daimler and MBUSA were neither incorporated nor had their principal place of business in California, Daimler’s contacts with California were not enough to render it at home in the state. Continue reading