Good morning, everyone. Nice to see you again. Unfortunately, the skies are overcast here at the Pharmalot campus, but our spirits remain sunny. That is due, in part, to the successive cups of stimulation and the little voice we hear reminding us that, “Every brand new day should be unwrapped like a precious gift.” A little optimism can be a good thing, yes? We certainly hope you agree. Meanwhile, here are the tidbits. Have a lovely day and do stay in touch …
Senator Chuck Grassley, who chairs the Senate Judiciary Committee, will hold a hearing on Nov. 30 to examine a controversial settlement agreement between the Department of Justice and Mylan Pharmaceuticals. The settlement, which is still being finalized, was reached to resolve allegations that Mylan shortchanged Medicaid for rebates related to its EpiPen device.
Mylan executives, meanwhile, are unlikely to lose pay due to the settlement, the Wall Street Journal writes. The reason is that the company historically has calculated executive pay using a nonstandard measure called “adjusted diluted” earnings. This excludes the costs of such litigation settlements, according to Mylan’s regulatory filings. New York City Comptroller Scott Stringer believes Mylan chief executive Heather Bresch should not be insulated.
Humana agreed to cover the controversial Sarepta Therapeutics drug for Duchenne muscular dystrophy, but with some stipulations. The key caveat is that patients must remain ambulatory — in other words, they can walk with assistance but not be dependent on a wheelchair. Despite the restriction, Humana joins UnitedHealthcare and Cigna in agreeing to provide coverage. Among the big insurers, only Anthem has declined to do so.
The decision to approve the Sarepta drug is “defensible, but only if there is adequate follow through,” writes Hastings Centers President Mildred Solomon in Health Affairs. “Compassionate response to the most vulnerable among us is a virtue, often described as emanating from the ‘rule of rescue,’ which calls on us to meet the needs of strangers in dire circumstances. Nothing is more dire than children living with fatal illnesses, like DMD. These children are terminally ill, there are no other viable alternatives, the drug seems to be safe, and while it is being used, it can be studied.”
The next user fee agreement for generic drug makers may lead to more competition and, perhaps, lower prices, Roll Call writes. In the next agreement, the Food and Drug Administration is committing to a 10-month review and an accelerated eight-month timeline for completing applications. The approach could mitigate drug shortages or speed approval of a first competitor to an existing medicine.
Why do we pay what we do at the pharmacy counter? The Biotechnology Innovation Organization just released a four-minute video that attempts to explain the process. Using simple illustrations, the video tracks a pill from the time the list price for a drug is set to the copay at the pharmacy. The message: Much of the cost is set by the insurer, employer, and pharmacy benefit manager. No mention, though, about how drug makers set prices.
Despite a strong earnings performance, Biogen remains in limbo, the Bloomberg Gadfly writes. Biogen stock is outperforming its peers this year, and the stock jumped 3 percent Wednesday after third-quarter earnings beat analyst expectations. However, the trajectory of its leading drug — the Tecfidera multiple sclerosis treatment — is uncertain, and a search for a new chief executive officer continues.
A mutual recognition agreement between the European Medicines Agency and the FDA on inspecting facilities could be signed by January, InPharma Technologist writes, citing European Commission negotiators.