Amarin Sues FDA Because It Cannot Promote Off-Label Use of Vascepa

A small pharmaceutical company called Amarin — based out of Dublin, Ireland –recently filed a Complaint for declaratory relief against the FDA in the United States District Court for the Southern District of New York. Amarin along with four physicians that prescribe its drug, Vascepa (omega-3 fatty acid derived from fish), allege constitutional violations of the First (freedom of speech) and Fifth (restriction against vague laws) Amendments of the United States Constitution. An Answer has not yet been filed.

The promotion of off-label drugs is the heart of this case. Amarin would like to share with potential prescribers the results of its 2011 clinical study that Vascepa lowers triglycerides, a kind of fat in the blood associated with heart disease, in patients with “persistently high” levels. However, the FDA currently only approves the drug for use in patients with extremely high levels of triglycerides.

Amarin seeks to provide the off-label information to prescribers and not the general public. Physicians, who are permitted to prescribe off-label, are already prescribing the drug in line with the clinical study and Amarin takes the position that these physicians are currently inadequately informed. Further, Amarin seeks to disclose information that is truthful and not misleading.

Opponents have said that Amarin seeks to sidestep the FDA.  If drug companies were permitted to share the results of clinical studies with physicians, there would be no motivation to obtain FDA approval. The FDA has declined to comment other than to state that more comprehensive guidance is on the way. The resolution of the lawsuit as well as the FDAs anticipating guidance may have far-reaching implications for off-label promotion of drugs.

OCR Director Discusses Upcoming HIPAA Audits, Additional Rulemaking in 2015

Audits of Covered Entities and their Business Associates which are required under the HITECH Act have been delayed into 2015, according to a comments made by Jocelyn Samuels, the Director of Health and Human Services’ Office for Civil Rights (OCR), because audit procedures have not been finalized. During a recent conference call with the media, Director Samuels would not commit to a specific timeline for the audits. These new audits will be done in-house by OCR and incorporate lessons learned from audits conducted in 2012 by KMPG of 115 covered entities in addition to changes following enactment of the Final Omnibus Rule in 2013.   Although all aspects of HIPAA compliance may be examined, it is expected that through these audits, OCR will closely scrutinize organizational Risk Assessment and Risk Management.   OCR anticipates that these audits will help it to identify best practices and uncover risks and vulnerabilities to privacy and security. Also according to OCR, the audits are expected to allow it to provide additional guidance and further refine future rulemaking regarding security and privacy.

In addition to the highly anticipated audits, OCR’s other plans for 2015 include:

  • A proposed rule that would allow individuals adversely affected by breaches of their protected health information to share in a percentage of the fine assessed by OCR against the party or parties responsible for the breach.
  • Additional guidance regarding the “minimum necessary” rule, which OCR views as intended to advance the policy goal that PHI only be used or disclosed when necessary for a particular purpose or to carry out a specific function.
  • Further clarification and guidance concerning the use of cloud storage and cloud computing services that have proliferated since the last major regulatory pronouncements related to the Security Rule.
  • Rulemaking related to the provision of an accounting of PHI disclosures upon request to patients.