Drugs

Aegerion Corporate Integrity Agreement Revealing: Attorneys

A recent corporate integrity agreement (CIA) between Aegerion Pharmaceuticals and HHS’ Office of Inspector General (OIG) provides “insights into the safeguards OIG likely expects pharmaceutical manufacturers to implement with regard to their relationships with independent charitable foundation patient assistance programs,” attorneys from Hogan Lovells write in a 9/28 client alert. The CIA follows the company’s 9/22 guilty plea (see story) in Massachusetts federal court to two misdemeanor misbranding charges involving Juxtapid (lomitapide), indicated as an adjunct therapy to treat homozygous familial hypercholesterolemia, a rare disorder that that causes high cholesterol levels and early cardiovascular disease. According to the government, Aegerion failed to comply with the requirements of the Juxtapid Risk Evaluation and Mitigation Strategy program and because the drug’s labeling lacked adequate directions for all of Juxtapid’s intended uses.

The client alert says that some safeguards enumerated in the CIA “reflect OIG’s previous guidance on manufacturer donations to and interactions with independent charitable foundations. The bans on any involvement from the broader ‘commercial organization,’ on sales discussing charity assistance with [healthcare providers] and patients, and on any manufacturer involvement in the establishment of a disease state fund, however, are stronger positions than OIG has articulated previously. The CIA provisions also underscore the continued need for oversight from compliance and legal and the need for manufacturers to document not only their interactions with independent charitable foundations, but also their internal processes for donations.”

The CIA imposes two obligations on the company regarding arrangements and interactions with independent charitable foundations, according to the client alert. “First, Aegerion must implement and maintain policies and procedures that address the funding of, and arrangements and interactions with, independent third-party patient assistance programs,” it says. “The policies and procedures must comply with federal healthcare program and FDA requirements, as well as a 2005 OIG Special Advisory Bulletin and a 2014 Supplemental Special Advisory Bulletin. Second, Aegerion must develop and implement a monitoring program for a number of activities, including donations to independent third-party patient assistance programs.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome