Senators lambast new Alzheimer’s drug’s price but give Janet Woodcock a free pass on the approval decision
Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.
“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.
Chair Ron Wyden (D-OR), while pledging to re-open his drug pricing legislation from the last Congress that would allow for CMS to negotiate drug prices, added, “If only a fraction of people suffering from Alzheimer’s were prescribed Aduhelm, Medicare Part B spending would double overnight.”
He also noted the more than $11,000 in co-insurance each year for those on the new Alzheimer’s infusion, adding that “overwhelmingly, the American public supports this idea” of further government drug price negotiations. And he signaled that President Biden’s pick for a new FDA commissioner is on the way.
Finance Chair Wyden says “authoritative sources” have told him Biden will name his pick to lead FDA soon.
— Alex Ruoff (@Alexruoff) June 10, 2021
The senator’s comments follow questions from Wall Street analysts earlier in the week on the steep price tag for aducanumab.
HHS Secretary Xavier Becerra offered limited detail on his plan for drug price negotiations, but said he remained open to sitting down and coming up with a solution.
“The pharmaceutical lobbyists are out there fear mongering, and pressing us to pass some watered-down bill that fails to tackle drug prices head on, how do you think Congress should respond?” Sen. Elizabeth Warren (D-MA) said, noting that it’s part of the president’s agenda.
Becerra said he’ll leave it to Congress on what to craft, but said he thinks there should be a generational change on how to do business when it comes to prescription medication.
Warren called for “all of the priorities,” including authorizing price negotiations “with real muscle,” expanding Medicare benefits, and lowering the Medicare eligibility age.
Other Democrats sounded split on what to do with drug prices.
Sen. Bob Menendez (D-NJ), whose district includes some biopharma companies and is a critical vote for Democrats with the 50-50 Senate split, said he’s concerned that the government consistently takes revenue from the industry but that doesn’t lower the costs of drugs for consumers.
“For me, the bottom line is show me how you’re going to lower the price for consumers on prescription drugs,” and in a way that doesn’t stop industry from producing more life-saving vaccines, Menendez said. Two other Senate Democrats, Tom Carper (DE) and Catherine Cortez Masto (NV), who introduced price transparency legislation last year, signaled earlier that they might also not be ready for a big drug price negotiation bill.
Sen. Ben Cardin (D-MD) also raised questions on how HHS is dealing with drug shortages in light of the pandemic, especially when the profit motive is non-existent.
“We’re trying to boost the supply,” Becerra said, including through the use of more domestic manufacturing.
Woodcock silent on aducanumab
In another hearing on Thursday before a Senate Appropriations subcommittee, acting FDA commissioner Janet Woodcock testified on the FDA’s 2022 budget plan but said nothing of Monday’s approval of Biogen’s Aduhelm.
None of the senators questioned Woodcock on the accelerated approval, and her name has remained largely out of the spotlight since the approval decision was announced by the agency. FDA statements all came from CDER director Patrizia Cavazzoni and OND director Peter Stein, in addition to a letter from neuroscience head Billy Dunn to the advisory committee that voted against its approval.
Only Sen. Jerry Moran (R-KS), a member of the Congressional Task Force on Alzheimer’s Disease, mentioned the approval, and he praised Woodcock on it.
Meanwhile, three members of the advisory committee that reviewed aducanumab have now resigned in protest over the approval.
Both sides of the aisle also commended the FDA for quickly offering EUAs for the Covid-19 vaccines from Pfizer, Moderna and J&J and ensuring they’re safe and effective.
Woodcock’s testimony highlighted her agency’s budget plan, which seeks a net budget authority increase of $322 million, the bulk of which would go for infrastructure investments, and an increase of $18.8 million to ORA’s base funding to support FDA’s inspections program.