Notice to Health Care Providers and Entities. Within 30 days after the Effective Date, Indivior shall post in a prominent place on the main page of the health care professional section of its company website (or other placement agreed to in advance by OIG), a copy of a letter signed by Indivior’s Chief Executive Officer containing the language set forth below: As you may be aware, Xxxxxxxx recently entered into a civil, criminal, and administrative settlement with the United States and individual states in connection with Indivior’s sales and promotion of Suboxone Film. This letter provides you with additional information about the global settlement, explains Indivior’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleges that Indivior engaged in certain unlawful and improper conduct relating to the promotion of Suboxone Film. To address criminal liability, a subsidiary of Indivior agreed to plead guilty to criminal charges of making materially false statements relating to Indivior Corporate Integrity Agreement As part of the global settlement, Indivior 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 xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Indivior 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 Indivior’s representatives to Indivior’s Compliance organization or the FDA using the information set out below. Please call Indivior at [insert toll free number] or visit us at [insert web link] if you have questions about the settlement referenced above. Please call Indivior at [insert toll free number] or visit us at [insert web address] to report any instances in which you believe that an Indivior 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 Indivior Representative to the FDA’s Office of Prescription Drug Promotion at 000-000-0000. You should direct medical questions or concerns about Indivior products to [insert toll free number]. The Compliance Officer (or a designee) shall maintain a lo...
Notice to Health Care Providers and Entities. Within 90 days after the Effective Date, Forest shall send, by first class mail, postage prepaid and return receipt requested, a notice containing the language set forth below to all HCPs and HCIs upon which Forest currently calls. This notice shall be dated and shall be signed by Forest’s President. The body of the letter shall state the following: As you may be aware, Forest Laboratories, Inc., (Forest) recently entered into a global civil, criminal, and administrative settlement with the United States and individual states in connection with the promotion and distribution of certain of its products. This letter provides you with additional information about the settlement, explains Forest’s commitments going forward, and provides you with access to information about those commitments. In general terms, the Government alleged that Forest improperly promoted the drugs Celexa and Lexapro between 1998 and 2005, including by promoting the drugs for a use not approved by the Food & Drug Administration (FDA), and that Forest improperly distributed a formulation of the drug Levothroid between 2001 and 2003 which is no longer marketed. To resolve the matters related to Celexa and Levothroid, Forest Pharmaceuticals, Inc., a subsidiary of Forest, agreed, among other things, to plead guilty to two misdemeanor criminal violations of the Federal Food, Drug & Cosmetic Act (FDCA) and to a felony charge of obstruction of a government agency proceeding. Forest did not admit any wrongful conduct related to Lexapro. Forest agreed to pay a total of $313 million to the Federal Government and State Medicaid programs as part of the overall resolution of these matters. More information about this settlement may be found at the following: [Forest shall include a link to the USAO, OCL, and Forest websites in the letter.] As part of the federal settlement, Forest 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 xxxx://xxx.xxx.xxx/fraud/cia/index.html. Under this agreement, Forest 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 Forest’s representatives to Forest’s Compliance Department or the FDA. Please email Forest at xxxxx...
Notice to Health Care Providers and Entities. Within 90 days after the Effective Date, Cephalon shall send, by postage prepaid first class mail, Certificate of Mailing requested, an exact copy of the notice attached hereto as Attachment A, showing the date of the mailing, to any health care provider or entity that Cephalon currently details. This mailing shall notify each health care provider and entity of the terms of the global settlement with the United States, including an explanation of the conduct to which Cephalon pled guilty and the conduct resolved by the civil settlement. The mailing shall also notify each health care provider or entity that they may report any questionable conduct by Cephalon representatives to a compliance telephone number or e-mail address established by Cephalon or to the FDA. The Chief Compliance Officer (or a designee) shall maintain a log of all calls and messages received by Cephalon in response to the notice. The log shall include a record and summary of each call and message received (whether anonymous or not), the status of the call or message, and any corrective action taken in response to the call or message. The disclosure log shall be made available to OIG upon request. As part of the Implementation Report and each Annual Report, Cephalon shall provide to the OIG a summary of the calls and messages received.
