| | | |   | | | | | Google’s revolving door with the FDA Are you an FDA official looking for a new gig? Verily might be interested.
In the year after former FDA principal deputy commissioner and acting chief information officer Amy Abernethy joined Google’s health and life sciences company, the company added four more former FDA employees, three of them on the same clinical studies platform Abernethy’s working on. In between the slew of hires, a top Google official went the other direction: The Senate confirmed Robert Califf, who had led Verily and Google Health’s health policy and strategy, in his second stint as FDA commissioner.
Those close ties give Verily a timely insight into clinical trial regulations that could shape the company’s whole business. For instance, both Califf and Abernethy have championed evolving trials through tools like real-world evidence, but there hasn’t been much clarity on the FDA’s thinking, my colleague Katie Palmer writes.
Health analytics companies like members of the Real World Evidence Alliance are hoping to shape a debate that has its fair share of detractors. But few may be better prepared than Verily to navigate conversations with FDA regulators.
“Being at FDA, it really helped me understand why certain things were so important and how to make sure I prioritize them in the right way,” said Abernethy. Read more from Katie here. | HHS sketches landscape for drug price changes HHS has a new pair of reports that could serve as measuring sticks for the impact of the sweeping drug pricing reforms Democrats finally got across the finish line this summer.
Saturday marked the introduction of so-called inflation caps — or fines on price hikes that exceed inflation — in Medicare Part D. Its Part B counterpart, also passed in the sweeping Inflation Reduction Act this August, will go into effect in January 2023. (The third major drug measure in the IRA, letting Medicare negotiate certain prices, won’t start for three years.)
What if it had all happened sooner? HHS predicts that price changes for more than 1,200 drugs would have been subject to fines if the inflation penalties were in place from July 2021 to July 2022. Price hikes for those drugs averaged more than 30% during a time when inflation hovered around 8.5%.
The federal agency also made its case for the looming negotiation plan, noting that a handful of speciality drugs drive most spending and that costs for those products ballooned 43% from 2016 to 2021, totaling $301 billion. That’s not necessarily a surprise, but the report nods to the power Medicare now has to name and negotiate, starting with 10 of the highest-cost drugs. | Summing up the health spending debate  (CBO) You probably don’t associate the Congressional Budget Office with light reading. But if you’re looking for a concise explanation of the decades-long discussion about how to lower health care spending, the budget wonks have you covered, my colleague Bob Herman writes.
One slide in a recent CBO report starkly lays it out: Capping the prices that hospitals, doctors and other providers charge private health insurers would lower prices significantly more than proposals to boost transparency or increase competition.
The simple flow chart throws cold water on two approaches pushed by various industry advocates eager to avoid price caps, a divisive move that’s soon to be launched against some high drug prices. While price transparency and competition could help with costs, CBO sees them as having “very small” and “small” impacts, respectively.
CBO’s latest report came at the request of House Budget Committee Chair John Yarmuth (D-Ky.), who has requested several other analyses of high health care costs in the the country. More from Bob, here. | How 10 million medicines, vaccines and healthcare products reach pharmacies and providers every day As the logistics experts of healthcare, distributors ensure the safe, efficient and reliable delivery of 10 million medicines, vaccines and healthcare products to 180,000 pharmacies and providers every day — helping millions of patients nationwide get medicines whenever and wherever they need them. Learn more about the backbone of the U.S. healthcare ecosystem and how the distribution industry is ensuring health is delivered. | What’s next in the open science push? The White House plan to make federally-funded science publicly available sooner could change the landscape of research access — though the average American might not notice.
The White House specifies only that new embargo-free manuscripts must be publicly available “in agency-designated repositories” like PubMed Central, not on journal websites. Would-be readers are still going to have to trace new papers to the repository of the agency that funded the work in order to read them for free, my colleague Brittany Trang writes.
There’s also concerns that a shift in research journals’ business models would perpetuate inequities by placing a bigger burden on authors through hefty processing fees. Established and well-funded researchers could take those changes in stride, but early-career scientists will be “suffocated,” argues Sudip Parikh, CEO of AAAS.
The federal guidance doesn’t mandate a publishing model, meaning these details are likely to be hammered out in the years ahead. In the meantime, open science advocates are applauding a major move to make taxpayer-funded research easily accessible. Read more here. | Pharmacists can now administer monkeypox shots HHS Sec. Xavier Becerra last week expanded the pool of providers who can administer monkeypox vaccines, citing the possibility of large-scale vaccination efforts.
For months, pharmacist organizations had pressed the administration to free their members to order and administer vaccines. The American Pharmacists Association applauded the move in a statement but raised another challenge: Paying for the shots. “It is important for the government to provide a pathway for reimbursement for pharmacists to provide this needed care,” APhA CEO Ilisa Bernstein said. | What we're reading - Many trials to confirm benefits of drugs granted accelerated approvals are running late, STAT
- Will there be a new Covid-19 winter wave? What scientists say, Nature
- Opinion: Will there be a Supreme assault on public health? STAT
- Severe sleep apnea diagnosis panics reporter until he finds a simple, no-cost solution,
Kaiser Health News - Harassment prompts children’s hospitals to strip websites, threatening access to gender-affirming care, STAT
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