News, Resources, and Events Tagged "Rachel Sachs"
CBO projects Senate drug pricing bill would cut the development of 10 drugs over 30 years
“The reason the number is smaller is that the package has changed over time,” Rachel Sachs, a law professor at Washington University in St. Louis told Endpoints News.…
Here’s what Democrats changed in their latest drug pricing bill
The text released Wednesday is similar to a sweeping package that passed the House last year — it would allow Medicare to negotiate prices with drugmakers, it would protect seniors…
People with chronic illness in US now risk having medication restricted
“Maybe industry feels secure for now, but I don’t think they should,” said Rachel Sachs, a professor at Washington University in St Louis who specialises in…
Accelerated Approval — Taking the FDA’s Concerns Seriously
User-fee reauthorization creates new opportunities for the FDA to address issues with its accelerated-approval program, including the lack of evidence of clinical benefit for some products.
Step Therapy’s Balancing Act — Protecting Patients while Addressing High Drug Prices
The debate regarding step therapy reflects a tension between two important policy goals: safeguarding patients’ access to high-quality care and constraining spending on prescription drugs, including by limiting the…
Opinion: A placebo-controlled trial requirement from CMS will spell the end of Biogen’s controversial Alzheimer’s drug
“Biogen’s FDA approval was always contingent on the completion of a confirmatory clinical trial,” Washington University in St. Louis law professor Rachel Sachs told Endpoints. &ldquo…
The USC-Brookings Schaeffer Initiative for Health Policy Welcomes Three New Non-Resident Fellows
Rachel Sachs is the Treiman Professor of Law at Washington University in St. Louis School of Law. She is a scholar of innovation policy, exploring health law, food and drug…
Finally, Medicare Takes A Step Towards Cost-Control - And Alzheimer’s Advocates Push Back
Back last June, the FDA made the controversial decision to approve a medication intended to treat Alzheimer’s disease, despite the lack of solid evidence of that drug&rsquo…
What are the challenges in developing information around mixing-and-matching COVID-19 vaccines and therapies?
The FDA has now authorized three vaccines and several treatments (including both monoclonal antibodies and small-molecule drugs) for the prevention and treatment of COVID-19. But the initial evidence supporting these…
Understanding Medicare’s Aduhelm Coverage Decision
Yesterday, the Centers for Medicare and Medicaid Services (CMS) issued a draft National Coverage Determination (NCD) proposing that monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s…
Medicare’s Unprecedented Alzheimer’s Drug Decision
Last week, Medicare took an unprecedented step to restrict patients’ access to the first new treatment for Alzheimer’s disease in nearly 20 years. We talk with a doctor,…
Could Alzheimer’s Drugs Avoid Medicare Coverage Restrictions If They Are Covered By Part D?
Biogen exec suggests subcutaneous injectable forms of Alzheimer’s treatments subject to Medicare’s draft national coverage determination might find better patient access if they are covered by…
Medicare proposes limiting coverage of controversial Alzheimer’s drug
Shares of drugmaker Biogen tumbled almost 7% yesterday after Medicare placed limits on its coverage of the company’s new Alzheimer’s drug. Biogen had already slashed the price…
Alzheimer’s groups vow to fight proposed Medicare restrictions on controversial drug
Alzheimer’s advocacy groups on Wednesday vowed to fight a preliminary Medicare decision to restrict coverage of a controversial new drug to patients in clinical trials, a move that…
The controversial Alzheimer’s drug isn’t getting much love from Medicare
Access restricted: Medicare is proposing to only cover the new, pricey Alzheimer’s drug for patients enrolled in certain clinical trials, a condition that would severely limit its use. …
Make or break for Biogen: How the national coverage decision for amyloid-targeted Alzheimer’s drugs will shake out
Ever since Biogen’s controversial Alzheimer’s drug Aduhelm won an accelerated approval in June, despite scant evidence of clinical benefit, the country has turned its attention to…
A looming decision on Medicare coverage for Biogen’s Alzheimer’s drug could shock state Medicaid programs
Shortly after the controversial Biogen drug Alzheimer’s was approved in the U.S. last year, a pair of state Medicaid directors tried to ring alarm bells.
Medicare must soon say whether it will cover the pricey new Alzheimer’s drug
It’s a massive week for the pricey, new Alzheimer’s drug. Medicare officials are bumping up against a critical Wednesday deadline to issue a proposal on whether …
Podcast: Prescription Drug Policy, Drug Pricing & Aduhelm With Rachel Sachs
While COVID-19 shallowed many headlines in the health care space, a lot of movement was made in various health policy areas, including prescription drug pricing. On today's episode of…
Prescription Drug Policy, 2021 And 2022: The Year In Review, And The Year Ahead
This past year was filled with news in the prescription drug policy area, from the Food and Drug Administration’s (FDA) most controversial drug approval in many years to…
Alzheimer’s experts call on FDA to pull Biogen’s Aduhelm
Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from…
Biogen Quickly Cuts Alzheimer’s Drug Cost After Payer Pushback
Biogen Inc. said it would cut the list price of its Alzheimer’s disease drug Aduhelm in half in the U.S., a move that comes after the treatment…
Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure
The US Food and Drug Administration (FDA) accelerated approval pathway allows new drugs with uncertain clinical benefits to be approved on the basis of clinical trials involving surrogate end points.…
Medicare Coverage of Aducanumab — Implications for State Budgets
CMS is considering whether and under what circumstances Medicare will pay for aducanumab for Alzheimer’s disease. A restrictive coverage determination could save the federal government money, but it…
Let’s Make a Deal…on Drug Prices
Democrats are on the brink of passing a historic set of drug price reforms. How will they impact patients, insurers and the drug industry?
Regeneron, Janssen Drugs Fit Profile Targeted in Spending Bill
The idea that drugmakers get a government-backed monopoly for a period of time to recoup their investment in new drugs and then must face competition has long been the &ldquo…
Opinion: The drug pricing deal isn’t really a victory for Dems, or a loss for PhRMA. But it could be a harbinger of change
Rachel Sachs, a law professor at Washington University in St. Louis who studies drug pricing and innovation, said she didn’t think companies potentially bringing in more competition prior…
Democrats are trying to cut drug costs for employers, too
By the numbers: Applying inflation caps to the commercial market would generate more than $150 billion in revenue for the federal government by 2030, according to an estimate by West Health. The…
Understanding The New Drug Price Reform Deal
Yesterday, the text of the Democratic deal on prescription drug pricing reform was released. These drug pricing reforms are intended to move forward as part of a broader reconciliation package…
Advocates express tempered optimism for Dems’ drug pricing deal
But Rachel Sachs, a health policy expert at Washington University in St. Louis, argued that the industry would have a negative reaction regardless of the scale of the drug pricing…
PhRMA Ad Misleads on Medicare Drug Negotiation Legislation
Rachel Sachs, a professor at the Washington University in St. Louis’ School of Law whose expertise includes food and drug regulation, and health law, told us that CBO predicts…
The Role of State Attorneys General in Improving Prescription Drug Affordability
Impact litigation initiated by state attorneys general has played an important role in advancing public health goals in contexts as diverse as tobacco control, opioids, and healthcare antitrust. State attorneys…
Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval
Question How much do prescription drugs approved through the US Food and Drug Administration’s accelerated approval program contribute to state Medicaid program spending? Findings In this cross-sectional study…
What the Stalemate on Capitol Hill Means for Your Drug Prices
As President Joe Biden’s government overhaul stalls in Congress, tensions are mounting over what changes ― if any ― could come for Americans at the pharmacy counter.
An ad’s charge that drug price haggling would ‘swipe $500 billion from Medicare’ is incorrect
The advertisement opens with a doctor sitting across from his patient and holding a prescription drug pill bottle. "You want to continue with this medication?" the doctor asks while an…
Inside the Battle for Drug Pricing Reform
Against a backdrop of heightened attention triggered by the FDA’s controversial approval of a new $56,000-a-year Alzheimer’s drug, the University of Pennsylvania’s Leonard Davis…
Health experts discuss high drug prices and potential for reform at virtual Penn event
Penn’s Leonard Davis Institute of Health Economics hosted a virtual seminar in which panelists discussed high drug prices and possibilities for reform in the present political climate. The…
Pressure Mounts On USPTO To Join Drug Pricing Fight
Law360 (September 20, 2021, 6:01 PM EDT) -- Congress, the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services have called on patent officials in the…
San Diego biotech allies warn drug pricing bill stifles cures. Critics don’t buy it.
San Diego’s biotech industry and allies are balking at a bill that would allow Medicare to negotiate drug prices, insisting the proposal would stifle innovation even as proponents…
Biden Drug Pricing Plan Seeks To Balance Access And Innovation
On Thursday, Health and Human Services (HHS) Secretary Xavier Becerra publicly released the Biden Administration’s Comprehensive Plan for Addressing High Drug Prices, as directed by President Biden&rsquo…
HHS extends Aduhelm investigation into the accelerated approval pathway, wading into a brewing controversy
The government investigation into how the FDA approved Aduhelm appears to point well beyond the agency’s ties with Biogen in the leadup to its approval of their controversial…
Patients Want Biogen’s Alzheimer’s Drug and Someone Has to Pay
Biogen has said as many as 2 million Americans might qualify for Aduhelm, though it expects fewer to actually get it. Still, if just half that many patients get it, the $57…
FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
Criticisms of the US Food and Drug Administration’s accelerated approval process have resurfaced after the recent approval of aducanumab (Aduhelm) for dementia. Elisabeth Mahase finds that the process…
Inside Biogen’s scramble to sell Aduhelm: Project 'Javelin' and pressure to ID as many patients as possible
In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program…
Biden’s executive order includes push for drug importation, but experts question feasibility
In a May court filing, the Biden administration argued the case was pointless because it's unclear whether any drug importation plans from states were going to be approved anytime…
How everyone on Medicare could end up paying for the pricey new Alzheimer’s drug
The controversial new drug for Alzheimer's disease, Aduhelm, is priced at $56,000 a year for treatment -- but Alzheimer's patients won't be the only ones shouldering the cost. …
New Drug Could Cost the Government as Much as It Spends on NASA
A newly approved drug to treat Alzheimer’s disease is expected to become a multibillion-dollar expense for Medicare. By one projection, spending on the drug for Medicare’s…
Opinion: The debate over the FDA-approved Alzheimer’s drug showcases our system’s skewed priorities
The Food and Drug Administration’s first approval of a drug to treat Alzheimer’s since 2003 should be a cause for celebration. Alzheimer’s is a scourge…
The Drug That Could Break American Health Care
Earlier this week, the Food and Drug Administration overruled—to much criticism—its own scientific advisory committee and approved the Alzheimer’s treatment Aduhelm. The agency made this decision despite…
Biogen’s Costly, Unproven Drug Feared as Health Budget Buster
The approval of Biogen Inc.’s $56,000-a-year Alzheimer’s therapy creates an unprecedented challenge for the U.S. health system: a drug that many patients may get at…
Opinion: How the FDA bent its rules for Biogen’s Alzheimer’s drug and why that’s bad for the entire biopharma industry
The FDA’s stunning accelerated approval for Biogen’s Alzheimer’s drug Aduhelm, with limited clinical evidence supporting the decision, will have repercussions across the entire biopharma…
By approving Biogen’s Alzheimer’s drug, the FDA is shifting its rules. That is a giant risk
In order to approve a new Alzheimer’s treatment, the Food and Drug Administration is rewriting its rulebook, an enormously risky move that could accelerate the public’s…
Aducanumab Accelerated Approval Reflects US FDA Flexibility But Raises Doubts About Confirmatory Trial
Biogen/Eisai Alzheimer’s drug wins agency nod on basis of amyloid plaque reduction, a surprising use of the accelerated approval pathway that was not considered by an FDA…
Drug Importation: Biden Response To PhRMA Suit Highlights Infeasibility Of Trump-Era Rule
Biden administration asks court to dismiss PhRMA’s lawsuit against Trump-era pathway for drug importation from Canada because FDA has not yet cleared any Section 804 Importation Programs (SIPs). The…
Encouraging Interagency Collaboration: Learning from COVID-19
In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and…
Biden Administration Signals It’s in No Rush to Allow Canadian Drug Imports
The Biden administration said Friday it has no timeline on whether it will allow states to import drugs from Canada, an effort that was approved under President Donald Trump as…
The Rhetorical Transformations and Policy Failures of Prescription Drug Pricing Reform under the Trump Administration
Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language to criticize the pharmaceutical industry…
Supreme Court pulls Medicaid work requirements case off docket
The Supreme Court announced Thursday it will no longer hear oral arguments later this month on an appeal over the controversial Medicaid work requirements program in New Hampshire and Arkansas. …
Are patents the cause of—or solution to—COVID-19 vaccine innovation problems? (No!)
Full author list: Jacob Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), Lisa Larrimore Ouellette, Nicholson Price (Former Academic Fellow), and Rachel Sachs (Former Academic Fellow) Are patents…
States still can’t import drugs from Canada. Now, many are seeking to import Canadian prices.
For years, former President Trump threatened to use foreign prices as a cap for what Americans should pay for drugs. Now that he’s left office without implementing the…
New Innovation Models in Medical AI
In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those which resemble traditional medical devices in…
Reference Pricing Clauses In US COVID-19 Contracts Leave Drug Industry Vulnerable
Innovation and price controls can coexist in the United States, COVID-19 contracts show. But drug pricing experts also acknowledge the unique circumstances of COVID-19 could make such contracts hard to…
Trump’s insulin order frozen, not scrapped, by Biden
Social media posts claim President Joe Biden overturned an executive order signed by his predecessor Donald Trump that aimed to lower insulin costs for US diabetics. This is false; Biden…
Why aren’t therapeutic antibodies being used more to treat COVID-19?
Complete author list: W. Nicholson Price II (Former Academic Fellow), Rachel Sachs (Former Academic Fellow), Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), and Lisa Larrimore…
While pandemic takes top priority for Biden, experts see favorable landscape for drug pricing action in Washington
Politicians of all stripes have run on promises to lower drug prices over the years, and outgoing President Donald Trump was no different. Fast-forward four years—past several attempts…
Column: Trump utterly failed to cut drug prices. Here’s how Biden could do better.
As a sort of sour welcome for the Biden administration and a final slap in the face for Donald Trump, America’s drug companies jacked up prices on hundreds…
Trump admin enlists private firm to review some Covid-19 tests
The Department of Health and Human Services is paying a private firm to review the accuracy of some Covid-19 tests — the latest example of the department’s political…
Rachel Sachs on COVID-19 EUAs, Trump’s last-minute drug pricing rules, & 2021 policy
Rachel Sachs, an associate professor of Law at Washington University in St. Louis, discusses with Klara the issued Emergency Use Authorizations (EUAs) on COVID-19 therapeutics and vaccines, President Trump's…
What can policymakers learn from the disastrously slow COVID-19 vaccine rollout?
In the middle of a record number of COVID-19 infections and deaths—and continued evidence of racial disparities in the pandemic’s effects—December brought some good…
How can policymakers encourage COVID-19 vaccine trials for children?
Complete author list: Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), Lisa Larrimore Ouellette, Nicholson Price (Former Academic Fellow), and Rachel Sachs (Former Academic Fellow) The…
Regulatory Disruption of the Year: HHS lab developed test policy
FDA review of laboratory developed tests has spurred contentious debate going back decades, with competing views about whether the agency holds regulatory authority. However, public health and legal experts contend…
What Joe Biden could do to bring down drug costs
Just as Joe Biden prepares to take over the presidency, the pharmaceutical industry is having its best political moment in years. Numerous Covid-19 vaccines are on the verge of approval,…
Trump’s Operation Warp Speed promised a flood of covid vaccines. Instead, states are expecting a trickle
Federal officials have slashed the amount of coronavirus vaccine they plan to ship to states in December because of constraints on supply, sending local officials into a scramble to adjust…
Trump to FDA: Why is Europe beating us on vaccine?
A president who preached "America First" is demanding to know why the United States could end up third, or worse, in the global vaccine race. President Donald Trump and his…
What administrative actions might we expect on COVID-19 in President-elect Biden’s administration?
Complete author list: Rachel Sachs (Former Academic Fellow), Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), Lisa Larrimore Ouellette, and Nicholson Price (Former Academic Fellow) When…
Poll: Biden must prioritize covid response
Nearly three weeks after the election, the president-elect's team is moving forward after GSA Administrator Emily Murphy on Monday finally acknowledged that Biden was the apparent winner of the…
Administration Finalizes Drug Pricing Rebate Rule At The Last Minute
On Friday, the Trump Administration issued final versions of two drug pricing rules it had proposed years ago: the “most-favored-nations rule,” first proposed in October 2018 (summarized here), and…
Administration Finalizes Most-Favored Nation Drug Pricing Rule At The Last Minute
On Friday, the Trump Administration issued final versions of two drug pricing rules it had proposed years ago: the “most-favored-nations rule,” first proposed in October 2018 (summarized here), and…
What role is AI playing in the COVID-19 pandemic?
Complete author list: Nicholson Price (Former Academic Fellow), Rachel Sachs (Former Academic Fellow), Jacob S. Sherkow (Former Edmond J. Safra Center and Petrie-Flom Center Fellow), and Lisa Larrimore Ouellette Promising…
Trump unveils controversial drug price rules in a last-ditch attempt to fulfill campaign promise
President Donald Trump unveiled two controversial rules on Friday aimed at reducing drug prices -- a last-ditch effort to fulfill a key 2016 promise that immediately sparked legal threats from the…
Trump pushes last-minute drug pricing rules likely to face big legal challenges
President Trump announced two sweeping drug pricing rules Friday that his administration is rushing to finalize before Inauguration Day to make good on his long-standing 2016 campaign promise to reduce what…
Trump’s recent drug pricing rules likely courtroom-bound, may up costs
Two drug pricing rules President Donald Trump is finalizing Nov. 20 are likely to end up in court or jettisoned by the incoming Biden administration, policy and legal experts said. Trump…
Trump administration pushes last-ditch plans to lower drug prices
The Trump administration on Friday put in motion two last-ditch efforts to deliver on the president's repeated promises to lower prescription drug costs in the U.S., announcing a…
A Final Try by Trump to Cut Drug Prices May Stumble in Court
Health officials on Friday finalized a policy that would base the price Medicare pays for certain drugs on the lowest price paid in some other developed nations. It is the…
What The 2020 Election Means For Prescription Drug Policy
At the time of this writing, Former Vice President Joe Biden has been declared the President-elect, with Democrats having retained control of the House of Representatives. However, due to two…
Trump’s Last-Minute Push For Legally Tenuous Prescription Drug Cards
In a gambit to boost President Donald Trump’s flagging poll numbers among seniors, the Trump administration is hastily assembling a plan that would put $200 debit cards for prescription…
Confronting State Medicaid Drug Spending Pressures
Across the country, state Medicaid budgets are under increasing strain, driven by factors including the high and increasing prices of prescription drugs. Nearly 30% of state spending supports Medicaid programs,1 and…
Health officials scrambling to produce Trump’s ‘last-minute’ drug cards by Election Day
Caught by surprise by President Donald Trump’s promise to deliver drug-discount cards to seniors, health officials are scrambling to get the nearly $8 billion plan done by Election Day,…
Trump’s Operation Warp Speed could be a success. The problem is Trump.
A Covid-19 vaccine could be approved in record time, thanks to an unprecedented mobilization by the federal government and private sector — but it almost certainly isn’t coming…
For Many in the U.S., Prescription Drugs Still Unaffordable
There were many notable moments at last week’s chaotic presidential debate, from President Trump’s refusal to condemn white supremacy to his swipes at Democratic nominee Joe…