Dear Patients, Physicians, Employees, Shareholders, Partners and Stakeholders,
As you may be aware, Aegerion Pharmaceuticals, Inc. (Aegerion) recently entered into a global civil, criminal, and administrative settlement with the United States and individual states in connection with Aegerion’s promotion and sales of its product Juxtapid. This letter provides you with additional information about the global settlement, explains Aegerion’s commitments going forward, and provides you with access to information about those commitments.
In general terms, the Government alleges that Aegerion engaged in several types of unlawful and improper conduct. More specifically, the Government alleges that Aegerion unlawfully distributed Juxtapid for intended uses not approved by FDA and failed to comply with a Risk Evaluation and Mitigation Strategy required by the FDA for Juxtapid. The Government also alleges that certain Aegerion employees made false and misleading statements about Juxtapid, that the company violated certain patient privacy requirements, and that Aegerion made payments to an independent charity for patient co-payment assistance that violated the Anti-kickback Statute.
To address these issues, Aegerion pleaded guilty to violating the Federal Food, Drug, and Cosmetic Act and agreed to pay approximately $7 million in criminal fines and forfeiture. Aegerion also entered into a three-year Deferred Prosecution Agreement to resolve claims that it violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Separately, Aegerion agreed to enter into a civil Consent Decree of Permanent Injunction to be monitored by the U.S. Food and Drug Administration (FDA).
In addition, the federal government and several individual states alleged that Aegerion’s conduct violated the federal False Claims Act and equivalent state statutes. To resolve those allegations, Aegerion entered into a separate civil False Claims Act settlement whereby Aegerion agreed to reimburse federal and state health care programs approximately $29 million.
Finally, the Securities and Exchange Commission alleged that Aegerion’s conduct violated federal security statutes. To resolve those allegations, Aegerion entered into a separate civil securities settlement whereby Aegerion agreed to pay approximately $4 million. Copies of and more information about these settlements may be found at the following websites: https://www.justice.gov/civil/current-and-recent-cases#_Pharm2 and http://novelion.com/about-novelion/aegerion-pharmaceuticals/aegerion-government-settlement.
As part of the global settlement, Aegerion also entered into a five-year corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The corporate integrity agreement is available at https://oig.hhs.gov/compliance/corporate-integrity-agreements/cia-documents.asp. Under this agreement, Aegerion agreed to undertake certain obligations designed to promote compliance with Federal health care program and FDA requirements. We also agreed to notify healthcare providers about the settlement and inform them that they can report any questionable practices by Aegerion’s representatives to Aegerion’s Compliance organization or the FDA using the information set out below.
Questions regarding the settlements referenced above
Please call Aegerion at 1-855-463-8974 or visit us at http://novelion.com/about-novelion/aegerion-pharmaceuticals/aegerion-government-settlement if you have questions about the settlements referenced above.
To report inappropriate product promotion or questionable conduct
Please call Aegerion at 1-855-233-8089 or visit us at https://novelioncompliance.tnwreports.com to report any instances in which you believe that an Aegerion representative inappropriately promoted a product or engaged in other questionable conduct. Alternatively, you may report any improper conduct associated with prescription drug marketing committed by an Aegerion Representative to the FDA’s Office of Prescription Drug Promotion at 301-796-1200.
Medical questions or concerns about Aegerion products
You should direct medical questions or concerns about Aegerion products to 1-855-303-2347 or http://www.novelion.com/physician-resources/global-medical-information.
As part of the CIA, DPA, and the FDA Consent Decree, Aegerion has pledged to maintain the comprehensive compliance and ethics program it has now implemented, to undertake certain actions designed to advance compliance with federal health care programs, FDA requirements, HIPAA and other applicable laws and regulations, and to make periodic compliance certifications to the OIG, DOJ and FDA.
Aegerion is committed to a culture of integrity, transparency and ethics. We have made enhancements to strengthen our compliance efforts, including the appointment of a new executive team, board of directors and the implementation of a new Code of Conduct. As a company, we are deeply committed to legal and regulatory compliance and remaining in good standing with not only the government, but with the patients, physicians and other stakeholders with whom we interact. The Aegerion Board and new leadership team demonstrated this commitment to regulatory compliance by establishing a board-level compliance committee, chaired by former US Attorney Donald Stern, incorporating compliance metrics across our processes and introducing educational and training efforts to ensure that our employees fully embrace these core values.