EpiPen Maker Reportedly Offered States Discounts If They Cut Down Competition
Stat reports that Mylan made the rebates conditional on states requiring that competitors' products get special requests by clinicians to be covered by Medicaid. In other news, the Food and Drug Administration says it will hold a hearing on efforts by drugmakers to impede competition, and an Australian drug company that is linked to a U.S. congressman gets approval for U.S. trials.
Stat:
Mylan Offered EpiPen Discounts To States In Exchange For Exclusive Status
The pharmaceutical company Mylan offered rebates to at least six state Medicaid programs on the condition that the states would make it harder for Medicaid patients to obtain products that compete with its EpiPen auto-injector, according to email correspondence obtained by STAT. The rebates Mylan offered to state Medicaid programs were conditional upon them making EpiPen easily available while competitor products would require special requests by clinicians in order for them to be covered. (Swetlitz, 6/22)
Morning Consult:
FDA To Hold Public Hearing On ‘Gaming’ In Drug Industry
The Food and Drug Administration will hold a public meeting next month to investigate ways that federal regulations can be manipulated by brand-name drugmakers to impede generic competition from entering the market. The hearing, scheduled for July 18, is the latest step taken by newly installed FDA Commissioner Scott Gottlieb to have the agency take a more active role in policing drug prices. (Reid, 6/21)
Kaiser Health News:
FDA Ruling On Aussie Biotech Could Boost Congressman’s Investment
An Australian biotech company whose largest shareholder is a U.S. congressman has the greenlight to begin human trials in the U.S. for a drug to treat advanced multiple sclerosis. The Food and Drug Administration’s decision is the first step in a long approval process demonstrating a new drug’s safety and effectiveness before regulators allow it to go on the market. In Innate Immunotherapeutics’ case, it could help the company achieve its stated goal of striking a merger or partnership deal with a larger drugmaker. (Bluth, 6/21)
Meanwhile, legislators in Pennsylvania consider giving patients more access to experimental drugs —
The Philadelphia Inquirer:
Pa. 'Right-To-Try' Bill Moves Forward, But Would It Help Terminal Patients?
Pennsylvania is a step closer to joining 37 other states that have passed laws purporting to entitle terminally ill patients to try unapproved drugs. The Senate Health and Human Services Committee unanimously approved the “right to try” bill on Wednesday. In March, the proposal unanimously passed in a House committee, then went on to unanimous passage in the House of Representatives in April — unusually rapid legislative progress. (Whether the full Senate and Gov. Wolf will follow suit is unclear.) (McCullough, 6/21)
And drugmakers report progress against a difficult eye disease —
San Francisco Chronicle:
Drug Shows Promise Against Vision-Robbing Disease In Seniors
An experimental drug from Genentech is showing promise against an untreatable eye disease that blinds older adults — and, intriguingly, it seems to work in patients who carry a particular gene flaw that fuels the damage to their vision. Age-related macular degeneration is the leading cause of vision loss among seniors, gradually eroding crucial central vision. (Neergaard, 6/21)
