Advocacy Group Urges Biden To Fire FDA Officials Over Alzheimer’s Drug

Stat: Advocacy Group Urges HHS To Boot FDA Officials Over Biogen Approval
Reacting to the controversial approval of the Biogen (BIIB) Alzheimer’s drug, a leading advocacy group is urging the Biden administration to request resignations from or remove three top Food and Drug Administration officials, including acting agency commissioner Janet Woodcock. The approval “showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency,” Public Citizen wrote in a June 16 letter to Department of Health and Human Services Secretary Xavier Becerra. (Silverman, 6/16)

FiercePharma: Despite Controversy, Biogen's Aduhelm Is Already Generating Enthusiasm Among Doctors: Survey
Biogen’s Aduhelm may have stirred up controversy after its landmark FDA approval, but some Alzheimer’s disease doctors are tabling the many unanswered questions as they appear ready to prescribe the drug. Doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment, Jefferies analysts found after surveying 50 U.S. neurologists or psychiatrists who currently treat about 12,000 Alzheimer’s patients. (Liu, 6/15)

Stat: Q&A: The CEO Of The Alzheimer’s Association On The Approval Of Aduhelm
Harry Johns is ready to stop talking about whether or not the Food and Drug Administration should have approved Aduhelm, the divisive new Alzheimer’s treatment that got the green light last week. “Dwelling on the approval at this point is not productive for those who can benefit from the treatment,” said Johns, the CEO of the Alzheimer’s Association. The “negative voices” focused on criticizing the decision, he said, are “not pro-patient.” (Joseph, 6/16)

Philadelphia Inquirer: New Alzheimer’s Treatment Aduhelm May Be Too Costly For Many Seniors, Deepening Inequities
The price tag of $56,000 per year for Biogen’s new Alzheimer’s treatment could come with a bitter pill for some Medicare beneficiaries: out-of-pocket costs of up to $11,500. That financial hit is troubling to consumer advocates, because it raises the prospect of an even more divided health system: Many seniors will be unable to afford this drug. “The current price would make the drug out of reach for many that could potentially benefit. This would also further deepen the issues of inequity in healthcare that already exist,” said Kristina Fransel, executive director, Alzheimer’s Association Delaware Valley Chapter. (Brubaker, 6/16)

Politico: A Pricey New Drug That May Not Work? Why Drug Pricing Critics Are Staying Quiet
The FDA’s approval of an expensive new Alzheimer’s therapy would seem like the perfect candidate for inflaming Washington’s long-running debate over sky-high prescription drug prices. The drug was broadly approved for Alzheimer’s patients, despite scant evidence that it works and over widespread objections from FDA’s outside advisers. The $56,000 annual price tag, announced after the drug received FDA clearance Monday, was far higher than many Wall Street analysts had expected. And the drug is likely to drive up health insurance costs for 56 million older adults on Medicare while also socking taxpayers. (Luthi and Roubein, 6/12)

The Wall Street Journal: Biotech Rally Sparked By Alzheimer’s Drug Has Staying Power 
Wall Street is rightfully celebrating the first approval of an Alzheimer’s disease treatment in nearly two decades. A familiar threat is likely to re-emerge, but investors won’t likely be caught off guard. Dust-up or not, stock prices are moving higher. Biogen shares rocketed 38% higher that day, and the rest of the sector has come along for the ride. Eli Lilly, which has a similar Alzheimer’s drug under development, rallied 10% on Monday. The Nasdaq Biotechnology Index rose 6% for the week. (Grant, 6/13)