The Office of Inspector General (OIG) has concluded that it would not impose sanctions on a pharmaceutical manufacturer for operating a direct-to-patient product-sales program that allows certain customers to purchase a manufacturer’s brand-name product for a fixed cash price from
FDA releases draft guidance on the use of social media for the promotion of drugs and devices
The FDA has also released draft guidance describing its current thinking regarding the dissemination of benefit and risk information for drugs and medical devices on social media platforms with character space limitations, including Twitter and sponsored internet advertisements. The FDA
Phase 2 reporting opens June 1
By listserv message, CMS announced that applicable manufacturers and applicable group purchasing organizations (“GPOs”) can start Phase 2 of Open Payments registration and detailed data submission process on June 1. Phase 2 itself has two steps and Phase 2 closes
Maryland Court rules that a drug’s off-label status does not reflect the drug’s risks
On April 24th, Maryland’s highest court ruled that it is acceptable for patients to give their informed consent to drug treatment even if they are not informed that a drug is being prescribed for an off-label use because such information
FDA cracks down on drug maker’s Facebook page
On March 12th, the FDA published a letter it had sent last month to Switzerland-based drug maker IBSA Institut Biochimique SA regarding the false and misleading nature of a Facebook page for the company’s drug, Tirosint.
Specifically, the FDA’s Office
FDA’s Medical Device Modification Notification rules will remain mostly unchanged
On February 26, 2014, the Food and Drug Administration (“FDA”) submitted a “Report on FDA’s Policy to be Proposed Regarding Premarket Notification Requirements for Modifications to Legally Marketed Devices” to Congress, which concluded that the existing guidance under Section 510(k)
CMS announces reopening of claims denied under two midnight rule
On February 24, 2014, the Centers for Medicare and Medicaid Services (“CMS”) directed Medicare administrative contractors (“MACs”) to reopen all claims denied under the “two midnight” rule between October 1, 2013 and January 30, 2014.
The “two midnight” rule, issued
CMS offers new resources and guidance on two-phase approach to Sunshine Act reporting
The CMS has posted new resources to its “Open Payments” website to clarify its recently announced two-stage approach to registration and data submission. These resources include:
CMS delays data submission at least 30 days
In a posting to its Open Payments website (through which it communicates about the Sunshine Act), CMS announced that the March 31 data submission deadline (originally set under the statute for March 31, 2013 and delayed by rule to March
Vermont AG offers limited penalty for failure to report data
Today, the Vermont Attorney General’s Office announced an offer to accept a limited penalty from medical device and biologic manufacturers to resolve failure to report expenses related to health care providers under Vermont’s Prescribed Products Gift Ban and Disclosure Law