Where, when, and how we work has changed profoundly since I started practicing law but employment and privacy laws have not evolved to keep up with technological change and the reality of the “everywhere” workplace.
I would like to think that employment lawyers can provide some practical solutions to addressing policies that help draw the line between personal and business and yet protect valuable business assets.
Social media policies, integrating multi-jurisdictional privacy and employment laws, the gig economy … all of these developments are impacted by rapid technological change but legal developments have lagged.
Just think about the last “non-traditional” place you worked. In line at the grocery store? In your car? Where is your workplace?
Thirteen companies have agreed to settle with the Federal Trade Commission (FTC) charges relating to their participation in the U.S.–EU and U.S.–Swiss Safe Harbor Frameworks. Seven companies allegedly failed to renew their Safe Harbor self-certifications, including a sports marketing firm, two software developers, a research organization, a business information firm, a security consulting firm, and an e-discovery service provider. Another six allegedly failed to seek certification under the Frameworks, but nevertheless claimed in their privacy policies to be certified, including an amusement park, two sporting companies, a medical waste service provider, a food manufacturer, and an e-mail marketing firm. Last year, fourteen companies settled with the FTC over similar claims, and advocacy group named 30 companies in a complaint alleging that they were out of compliance with the Safe Harbor Frameworks.
The European Commission’s Directive on Data Protection prohibits the transfer of personal data to non-EU countries that do not meet the EU standard for privacy protection, so the U.S. Department of Commerce (DOC) negotiated the Safe Harbor Frameworks to allow U.S entities to receive such data provided that they comply with the Directive. To participate in the Safe Harbor Frameworks, companies must annually self-certify that they comply with seven key privacy principles for meeting EU’s adequacy standard: notice, choice, onward transfer, security, data integrity, access, and enforcement. Only appropriately self-certified companies may display the Safe Harbor certification mark on their websites, and the FTC is charged with enforcing violations.
This enforcement action is a reminder of the importance of maintaining current Safe Harbor status for those who elect to participate the program. It is also a reminder that companies must act in accordance with their published privacy policies, and periodically review their privacy policies to ensure that they remain current and reflect companies’ actual practices.
© 2015 Keller and Heckman LLP
Amarin Ruling Solidifies Off-Label Marketing Options but Raises Questions About False Claims Act Enforcement Action
The Southern District of New York recently ruled in Amarin Pharma, Inc. et al. v. Food and Drug Administration, et al. that a drug company may engage in “truthful and non-misleading speech” about off-label uses of an approved drug without the threat of a misbranding action under the Federal Food, Drug, and Cosmetic Act. No. 1:15-cv-03588 (S.D.N.Y., Aug. 7, 2015). This important decision—which arose out of Amarin’s constitutional challenge seeking to make certain statements about unapproved uses of a triglyceride-lowering drug, Vascepa—builds on recent Second Circuit precedent that allows drug makers more regulatory latitude, at minimum in the Second Circuit, to provide truthful and non-misleading scientific information about unapproved uses for their products. However, the ruling also serves as a reminder of potential False Claims Act (FCA) liability associated with off-label marketing of pharmaceuticals and devices.
Amarin filed its complaint against the Food and Drug Administration (FDA) after the company received a Complete Response Letter (CRL) from the FDA in connection with its application for approval of a new indication. The CRL indicated that, while clinical studies revealed that Vascepa reduced triglyceride levels, based on its data review, the FDA advised that additional clinical data would be needed before it could approve the drug for additional uses beyond the original approval for “very” high levels of triglycerides. Despite the fact that Amarin sought to make truthful and non-misleading statements about its product to “sophisticated healthcare professionals,” including the physicians who joined Amarin in the lawsuit, the FDA concluded there was insufficient support for approval of the supplemental application for a new indication and stated that any communications about off-label uses of Vascepa could result in enforcement action.
While the FDA described Amarin’s First Amendment claims as a “frontal assault on the framework for new drug approval that Congress created in 1962,” the court rejected all of the government’s counterarguments. Relying on the Second Circuit’s decision in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), the court held that Amarin could engage in the following activity:
Distribute summaries and reprints of the relevant studies in a manner or format other than that specified by the FDA
Articulate, in connection with Vascepa, the off-label claim permissible for use on chemically similar dietary supplements
Make proactive truthful statements and engage in a dialogue with doctors regarding the off-label use
While the Amarin decision is welcome news for the industry, drug manufacturers must still take care to analyze promotional statements to ensure that the content can be successfully defended as “truthful” and “non-misleading” speech. As the Amarin court acknowledged, manufacturers not only face potential criminal exposure for “false” or “misleading” misbranding, but the promotion of off-label use can give rise to civil claims under the FCA. FCA enforcement in off-label cases—which proceed on a theory that a company caused false claims to be submitted to government health care programs for non-covered and non-FDA-approved uses—have been a huge source of FCA recoveries in recent years. In FY2014, for example, the Department of Justice (DOJ) recovered over $2.2 billion in FCA actions against pharmaceutical and medical device companies stemming from off-label promotion. Regulatory enforcers and qui tam whistleblowers will not hesitate to allege FCA violations where circumstances, for example, allow the inference that narrowly couched promotional statements may have been “truthful” but still factually incomplete and, thus, misleading. The Amarin decision highlights the fact-specific nature of the risk analysis. Amarin relied on truthful statements about Vascepa’s off-label use that were largely derived from an FDA-approved study and writings from the FDA itself on the subject. Rather than shooting from the marketing “hip,” Amarin appears to have invested in building a defensible factual scientific record and preemptively sought an FDA opinion regarding the off-label use of Vascepa before engaging in those communications.
While it remains unclear whether the FDA will appeal the Amarin decision to the Second Circuit, the agency’s decision to let Caronia stand without further appeal suggests that there may be reluctance on the part of regulators to risk a higher court expanding the reach of the Caronia holding across the country. Pharmaceutical and device manufacturers should still proceed cautiously as the FDA determines how it will respond following the Amarin ruling. For example, the FDA updated its draft guidance regarding the dissemination of scientific and medical journal articles following the Caronia decision in February 2014 and agreed in June 2014 to conduct a “comprehensive review [of its] regulatory regime governing communications about medical products,” with the intent of issuing new guidance by June 2015. As the Amarin court noted, this revised guidance is still forthcoming and may be further revised in light of this decision.
© 2015 McDermott Will & Emery
The Airport Cooperative Research Program (ACRP) has recently published a guidebook on Renewable Energy as an Airport Revenue Source. The link to the guidebook on the ACRP website is here. David Bannard is a co-author of the guidebook, for which the lead authors were Stephen Barrett and Philip DeVita of HMMH.
Airports are exploring non-traditional revenue sources and cost-saving measures. Airports also present a unique and often accommodating environment for siting renewable energy facilities, from solar photovoltaics (PV) to thermal, geothermal, wind, biomass and other sources of renewable energy. Although the guidebook focuses on the financial benefits of renewable energy to airports, it also notes other business and public policy benefits that can accrue from use of renewable energy at airports.
The guidebook includes case summaries of 21 different renewable energy projects at airports across the United States and in Canada and the U.K. Projects summarized include solar PV, wind, solar thermal, biomass, and geothermal technologies. In addition the guidebook examines factors to be considered when evaluating airport renewable energy projects, conducting financial assessments of airport renewable energy and issues relating to implementing airport renewable energy projects. Airports present unique challenges and opportunities for development of renewable energy facilities. The ACRP’s recent publication helps both airport operators and renewable energy providers and financiers understand and address many of these complex issues presented in the airport environment.
© 2015 Foley & Lardner LLP
On August 18, 2015, EPA released additional components of President Obama’s Climate Action Plan. The four separate actions are intended to reduce greenhouse gases and other emissions from the oil and natural gas sector. The newly-released components include:
1) Additional New Source Performance Standards;
2) New Control Techniques Guidelines;
3) Proposed revisions to the regulatory definition of covered oil and gas equipment; and
4) A proposed Federal Implementation Plan for Indian Country New Source Review.
Each is discussed in turn.
New Source Performance Standards
First, EPA has proposed additional New Source Performance Standards that will:
Reduce 95% of the methane and VOC from compressor stations, specifically requiring modifications to wet seal centrifugal compressors and replacement of rod packing at reciprocating compressors based on a set number of hours of operation or route emissions into a closed vent system.
Establish a standard bleed rate limit across all natural gas-driven pneumatic controllers.
Establish a lower standard (zero) bleed rate limit at natural gas processing plants.
Reduce emissions from all pneumatic pumps at different rates and with different technologies.
Require “green completions” at hydraulically fractured well sites, using capture and combustion devices to reduce emissions.
EPA reconsidered various issues from the 2012 proposals, and is proposing actions concerning such issues as storage vessel monitoring, Leak Detection and Repair requirements, monitoring methods, and fugitive emission issues.
Although EPA has proposed the above New Source Performance Standards, EPA is also soliciting comment on “alternative approaches” that would meet the above guidelines. EPA appears willing to consider alternative approaches because it has encouraged companies to reduce emissions in numerous ways voluntarily over the last several years, including as recently as June 2015 with its modified Energy Star program, and EPA indicates it does not want to impede equivalent reduction strategies.
VOC emission Guidelines from certain oil and gas facilities
Second, EPA is proposing Control Techniques Guidelines (CTGs) for reducing VOC emissions from certain oil and gas facilities in the northeast Ozone Transport Region. These guidelines, proposed under Clean Air Act (CAA) Section 172(c)(1), will be used by states to set “reasonably available control technology” for existing sources of emissions. CTGs are recommendations for technologies and practices to reduce emissions from existing sources in certain ozone non-attainment areas. States may be required to modify their State Implementation Plans for certain sources within two years after the final CTGs are issued.
Amendments to what facilities are “adjacent” for permitting purposes
Third, EPA is proposing to define the term “adjacent” for purposes of evaluating when oil and gas equipment and activities are considered part of the same source. EPA proposes two alternatives: One defines “adjacent” by reference to proximity; the other in terms of function. EPA requests comment on both definitions. Either approach represents a potential change to current definitions as many oil and gas development wells are located in close proximity but in such a manner as that avoids meeting EPA’s traditional test as a “common source.” “Common sources” can be classified as “major sources” with more stringent emission limits.
Proposed Federal Implementation Plan for Indian Country
Last, EPA is proposing a Federal Implementation Plan (FIP) for Indian Country Minor New Source Review. EPA required tribes administering the CAA to establish minor New Source Review programs in 2011. This FIP will be imposed in areas where acceptable programs have not been implemented. Because many oil and gas well sites are “minor” new sources, the FIP will provide guidance on air permitting for drilling in tribal territories.
More information, including the proposed rules and fact sheets, can be found at EPA’s website: http://www.epa.gov/airquality/oilandgas/actions.html.
© 2015 Schiff Hardin LLP