News, Resources, and Events Tagged "Pharmaceuticals"
Pediatric Drug and Other Shortages in the Age of Supply Chain Disruption
The last year witnessed several significant shortages of key medicines and other products for children, including children’s formulations of acetaminophen and ibuprofen as well as frontline antibiotics prescribed…
Patient-Assistance Programs, Kickbacks, and the Courts
Pharmaceutical companies have sought to reduce cost sharing by means of patient-assistance programs. Some such programs have been under scrutiny because of questions about whether they violate federal law.
The Antibody Patent Paradox
The immune system produces antibodies as a defense to foreign agents called antigens. When a particular anti- gen—a virus, for example—enters the body, the immune system…
Supreme Court Sides with Sanofi, Regeneron in Patent Fight with Amgen
Gorsuch acknowledged a patent does not need to disclose each single possible embodiment of the invention. But he added that examples of the claimed class need to have some common…
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…
Pharma Patents Threatened by Federal Circuit, Petitions Say
If the Juno and Amgen decisions are left in place by the Supreme Court, no attempt to define an antibody will be enough to satisfy the Federal Circuit, said …
Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations
Patients with rare diseases often have limited or no options for approved treatments or participation in clinical trials. In such cases, expanded access (or “compassionate use”) provides a…
FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies
Five years ago, the Food and Drug Administration launched a new program with the best of intentions: to speed the development and review of cutting-edge and potentially lifesaving medical devices,…
Incremental benefits of novel pharmaceuticals in the UK: a cross-sectional analysis of NICE technology appraisals from 2010 to 2020
Objectives: To evaluate the incremental value of new drugs across disease areas receiving favourable coverage decisions by the UK's National Institute for Health and Care Excellence (NICE) over…
Controversial Alzheimer’s drug approval ignites FDA reform debate
The FDA's conditional approval of a controversial Alzheimer's drug last year has sparked heightened scrutiny and an attempted overhaul of a popular regulatory pathway used to fast-track…
Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel
Prescription drugs and medical devices are increasingly coming to market through expedited US Food and Drug Administration (FDA) pathways that require only limited evidence of safety and efficacy, such as…
Institutional Review Board Use of Outside Experts: What Do We Know?
Institutional review boards (IRBs) are permitted by regulation to seek assistance from outside experts when reviewing research applications that are beyond the scope of expertise represented in their membership. There…
As states push their own privacy laws, health tech companies fear compliance nightmare
Health tech companies worried that an emerging patchwork of state privacy laws will drive up regulatory costs are joining privacy hardliners in the call for one nationwide standard to govern…
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…
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,…
Pharmacies shouldn’t be the only place to get Paxlovid, the new Covid pill
It’s easy to feel like we’re in a pandemic “Groundhog Day” loop as the U.S. faces yet another Covid-19 surge with overwhelmed hospitals,…
Patent thickets are thwarting U.S. availability of lower-cost biosimilar medicines, study finds
Amid debate over competition in the pharmaceutical industry, a new analysis found just 6% of patents covered key ingredients — or innovative new molecules — in pricey biologic medicines, underscoring concerns…
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. …
A new Alzheimer’s drug shows why the FDA’s speedy approval process is broken
Whether it’s covid or cancer, when you’re a patient facing a life-threatening disease without good treatment options, your risk tolerance is bound to be pretty high.…
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…
Two views of cancer medicines: Imagery versus evidence
Despite advertising imagery portraying cancer medicines as offering substantial improvement or cure, most patients can expect modest or no incremental benefit from most new treatments, according to pre-specified criteria. When…
Who Invented Covid-19 Vaccines? Drugmakers Battle Over Patents
A high-stakes legal battle is taking shape over lucrative patent rights for Covid-19 vaccines, with drug companies pitted against each other and government and academic scientists over who invented what. …
Call for Papers: 2022 Jaharis Health Law Symposium, DePaul College of Law
The DePaul Journal of Health Care Law, Mary and Michael Jaharis Health Law Institute, and Center for Intellectual Property Law & Information Technology (CIPLIT®) are excited to…
PORTAL Fellowship, Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School
The Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School invites its 2022 round of applications for postdoctoral fellows in pharmaceutical…
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…
Every drug should be labelled to tell you how well it works
When buying over- the-counter drugs or being prescribed medication by your GP, what’s the one thing you want to know? The answer is obvious, of course: how well…
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.…
Challenges in confirming drug effectiveness after early approval
It’s easy to understand the urge to make potentially beneficial drugs quickly available to patients in need. It’s also easy to go too far. Through its 2021…
Vaccines, Regulation, and Patents: A Conversation with Harvard Medical School Professor Dr. Jonathan J. Darrow
HHPR Senior Editor James Jolin interviewed Jonathan Darrow, S.J.D., LL.M., J.D., M.B.A, an Assistant Professor of Medicine at Harvard Medical School and a Faculty…
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…
Simplify drug labelling to show benefits clearly
Aducanumab, an Alzheimer’s disease treatment, was approved by the US Food and Drug Administration (FDA) in June this year despite a lack of robust evidence that it actually…
Moderna and U.S. at Odds Over Vaccine Patent Rights
Moderna’s patent application names several employees as the sole inventors of a crucial component of its coronavirus vaccine, excluding three government scientists.
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…
Dems resurrect a scaled back plan for Medicare drug price negotiations
Only a few days after President Joe Biden seemed to signal that drug pricing reforms were left for dead, Democrats are already circulating plans for a scaled-back version of what…
Problematic Interactions Between AI and Health Privacy
The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens…
German Pharmaceutical Pricing: Lessons for the United States
To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell…
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…
Pharmaceutical Companies, Human Rights, and the Alien Tort Statute
On January 3, 2019, U.S. District Judge Theodore D. Chuang of the U.S. District Court of the District of Maryland took a crucial first step in redressing one of the…
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…
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…
Picking Embryos With Best Health Odds Sparks New DNA Debate
Rafal Smigrodzki won’t make a big deal of it, but someday, when his toddler daughter Aurea is old enough to understand, he plans to explain that she likely…
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…
In new remarks, Cassava Sciences’ CEO shifts defense of embattled treatment for Alzheimer’s
Cassava Sciences CEO Remi Barbier on Monday shifted his defense of the company’s embattled treatment for Alzheimer’s disease: The drug is safe, he said, therefore the…
A Snapshot of U.S. IRB Review of COVID-19 Research in the Early Pandemic
Background/Objective: Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating…
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. …
In Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug
The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. Now it recommends that the drug be given only to those with mild symptoms.
Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling
A prescription drug’s package insert (or labeling) is a document written by the manufacturer and first approved by the US Food and Drug Administration (FDA) as part of…
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…
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…
Off-Label Innovation
Modern medicine faces many significant challenges. This Article is about two of them. The first is that approved drugs have many potential therapeutic uses that are never identified, investigated, or…
Retirees stuck in the middle of debate over drug-price reform
Dr. Jeffrey Pevnick was on the brink of retirement last year when he was diagnosed with a potentially fatal heart condition and thrown a financial curveball: The St. Louis psychiatrist…
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…
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…
Few new drugs deserve expedited regulatory treatment
Safety testing of new drugs has been required since the 1938 Federal Food, Drug, and Cosmetic Act, but applications were automatically approved under that law unless the US Food and Drug…
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…
Reining in drug patents isn’t a silver bullet against high drug prices
One of the top orders of business for the Biden administration is curbing drug prices. It’s a laudable goal. High drug prices are a major public health concern;…
EpiPen, Patents, and Life and Death
Drug pricing disputes, while significant public health concerns, are not typically immediate life or death matters. But they may be for certain emergency medicines, medicines used for potentially lethal and…
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…
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…
Beyond The High Prices Of Prescription Drugs: A Framework To Assess Costs, Resource Allocation, And Public Funding
During the past century, an accumulation of laws, organizations, and policy mechanisms has led to increasing transfers of public funds to private drug manufacturers, straining budgets and enabling industry revenues…
F.D.A. Approves Monthly Shots to Treat H.I.V.
It’s what many people with H.I.V. have long awaited: monthly injections to keep the virus in check, instead of the three drugs daily they now must…
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 leaves behind largely unworkable drug-pricing policies
Between legal challenges and practical implementation problems, President Trump isn’t leaving much policy for the Biden team to work with. But he did shift the drug-policy conversation.