AEGERION COMPLIANCE INFORMATION

1. Compliance Reporting & Hotline Information

Questions, comments, and incidents pertaining to a suspected violation of Aegerion policy, law or regulation, or ethical standards may be reported via the means listed below.  The web portal and telephone Helpline are supported by a third party, and are available 24 hours per day, 7 days per week.  Anonymity is available for all reporting methods.
Do not use the Compliance resources to report issues pertaining to Human Resource complaints (e.g. harassment, bullying, employment matters), request medical information, to report Adverse Events, or to report Product Complaints.  Please see the information at the bottom of this page for assistance finding the proper recipient for such matters.

By Mail
Aegerion Pharmaceuticals Inc
245 First Street,
18th Floor
Cambridge, MA 02142

And phone number to 617.500.7867

Online Reporting

By Phone
(North America) 855-233-8089
A third-party vendor is available 24/7/365

Adverse Event & Product Complaint Reporting Information

At Aegerion Pharmaceuticals, our mission is to provide customers with timely and accurate information regarding our products. Please contact us by telephone or email as provided below. Please report adverse reactions using one of the contacts below.

by Telephone

Argentina 0800-222-1538
Belgium 00-800-2343-7466
Brazil 0-800-761-1818
Canada 1-855-303-2347
Colombia 01-800-710-2268
Croatia 00-385-1777-6525
Cyprus 00-800-2343-7466
Denmark 00-800-2343-7466
Finland 00-800-2343-7466
France 00-800-2343-7466
Germany 00-800-2343-7466
Greece 00-30-21-1198-3992
Ireland 00-800-2343-7466
Israel 00-800-2343-7466
Italy 00-800-2343-7466
Japan 03-4588-1317
Luxembourg 00-800-2343-7466
Malta 00-800-2343-7466
Mexico 800-266-0074
Netherlands 00-800-2343-7466
Norway 00-47-2103-4389
Portugal 00-800-2343-7466
Saudi Arabia 800-2343-7466
South Korea 02-3483-3336
Spain 00-800-2343-7466
Sweden 2-0089-6447
Taiwan 008-0113-6497
Turkey 008-0044-882-8535
United Kingdom 00-800-2343-7466
United States 1-855-303-2347

For any countries not listed, please call +1-855-303-2347

By Email

For all email contact, please click the link below and complete the simple Medical Information Request form. You will receive an immediate confirmation of your submission and will be contacted by us shortly.

 

Please direct any questions to ComplianceOffice@Aegerion.com

 

2. Open Payments: US Federal Transparency Disclosures

Introduction

Close collaboration between Health Care Professionals (HCPs) and the pharmaceutical industry is a regular practice that allows drug developers’ access to the knowledge necessary to create lifesaving medicines. In turn, the HCP community has both the opportunity to influence options available to patients, and obtain knowledge regarding the latest care and treatment. Be it through clinical research, advisory boards, medical education programs, or collaboration on lifesaving medicines – sharing knowledge to improve the lives of patients is the cornerstone of all interactions.

Types of Payments

Aegerion may choose to remunerate Health Care Providers by differing means, depending on the services provided, and the entity providing those services.  Types of payments may include any of the following:

  • Cash or cash equivalent
  • In-kind items or services
  • Stock, stock options, ownership interests, dividends, profits, or other return on investments
  • Any other form of payment or other transfer of value

Payments may be made for a variety of services, which CMS categorizes as the Nature of Payments.  Aegerion has reported transfers of value for the following reasons (grouped by CMS-defined Natures):

  • Charitable Contributions
  • Compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program
  • Compensation for serving as faculty or as a speaker for a non-accredited and noncertified continuing education program
  • Consulting Fees
  • Current or Prospective Ownership or Investment Interests
  • Education
  • Food and Beverage
  • Grants
  • Research
  • Space Rental or Facility Fees
  • Travel & Lodging

Use of the CMS Open Payments Database

The Open Payments Data website can be accessed via the links within this section or directly at (https://openpaymentsdata.cms.gov/).  Users are encouraged to familiarize themselves with the CMS-provided system documentation, such as The Open Payments User Guide, or Using The Open Payments Search Tool: A Quick Guide. Users may obtain and query the full dataset, or use the online Search Tool (https://openpaymentsdata.cms.gov/search/) to view reported payments made to Covered Recipients.

Open Payments has provided the following instructions to assist users in searching the data:

  • For physician data, search from the home page:
    • Enter a First Name and/or Last Name in the search boxes, and click Search.
    • When the results screen appears, click on the Physician Name link you wish to review.
    • A profile screen will display summary level information, as well as specifics by payment type and year.
    • Use the Search Tool to search by additional criteria.
  • For teaching hospital or company data, use the Search Tool:
    • Choose the appropriate option for a Teaching Hospital or Company
    • Enter information in the search boxes (Hospital/Company name, city, state, zip/postal code) and click Search.
    • On the results screen, click on the link for the one you would like to review.
    • A profile screen will display summary level information, as well as specifics by payment type

THE OPEN PAYMENTS DATA AND SYSTEM ARE NOT OWNED, MAINTAINED, CONTROLLED, OR OTHERWISE ASSOCIATED, IN ANY WAY, WITH AEGERION PHARMACEUTICALS OR NOVELION THERAPEUTICS, ITS EMPLOYEES, OR AGENTS.  AEGERION ASSUMES NO LIABILITY FOR ANY DAMAGES THAT MAY RESULT FROM THE USE OF THE OPEN PAYMENTS DATA WEBSITE, AND / OR DATA CONTAINED THEREIN.

Additional US Transparency & Disclosure Reporting

State mandated disclosure requirements that are substantively similar or identical to those required by Open Payments are preempted. Aegerion complies with all state requirements in which it conducts business.

Section 6004 of the PPACA, Prescription Drug Sample Transparency, further amended the Social Security Act by adding section 1128H, Reporting Of Information Relating To Drug Samples, to Title XI. This sets forth the requirements and process for the disclosure of information pertaining to drug and product samples to the FDA, and entered effect on April 01, 2012. Aegerion complies with all requirements under 1128H.

Pursuant to the Corporate Integrity Agreement implemented as part of Aegerion’s 2017 settlement with the United States and applicable states, a complete listing and description of grant support can be found here.

Please direct any questions to ComplianceOffice@Aegerion.com

 

AEGERION GRANTS DISCLOSURE

The table below contains information pertaining to Grants that are subject to disclosure pursuant to the CIA, including the name of the recipient, the name of the program funded, a brief description thereof, and the amount of the grant.

Recipient Program Name Program Description Grant Amount
American Heart Association Scientific Sessions 2017 Dedicated Track on Diabetes, Lipids, and Metabolic Syndrome $10,000
The Familial Hypercholesterolemia Foundation FH Global Summit Support Support for Japanese HCPs to attend 2017 FH Global Summit $14,000
The Familial Hypercholesterolemia Foundation FH Global Summit Support Support for Japanese HCPs to attend 2017 FH Global Summit $2,200
Regents of the University of Michigan Support for Lipodystrophy 2018 A Satellite Symposium and SOLID Development $100,000
Mayo Clinic Continuing Medical Education CME: Genetics of Heart and Vascular Disease $10,000
Endocrine Society ENDO 2018 Support for CME Lipid Sessions $35,000
National Lipid Association NLA Assessment Development and Implementation of NLA Assessment $102,162

Please direct any questions to ComplianceOffice@Aegerion.com