News, Resources, and Events Tagged "Fda"
Regulating Direct-to-Consumer Polygenic Risk Scores
Recently, polygenic risk scores (PGSs)—genome-wide measures of individuals’ genetic propensities—have come to consumers. PGSs are now directly available to individuals to assess type 2 diabetes risk,…
The FDA Declares Levonorgestrel a Nonabortifacient—A 50-Year Saga Takes a Decisive Turn
Levonorgestrel (Plan B), also known as the morning-after pill, was the brainchild of Yuzpe and colleagues nearly 50 years ago. The drug has been available over the counter since 2006. Even…
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…
To Protect Patients And Spark Innovation, Codify The FDA’s Oversight Of Laboratory-Developed Tests
The Food and Drug Administration (FDA) has long viewed the oversight of the safety and effectiveness of laboratory-developed tests as part of its regulatory mission. However, the scope of…
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.
Aspiring to Reasonableness in Accelerated Approval: Anticipating and Avoiding the Next Aducanumab
The US Food and Drug Administration’s decisions about drug approval—though guided by science, as well as relevant statutes, regulations, and guidance documents—reflect normative judgments…
Flexible Administration Of COVID-19 Vaccines And Therapeutics—Clarifying Legality, Liability, And Compensation
Over the past two years, the Food and Drug Administration (FDA) has approved or issued emergency use authorizations (EUAs) for several interventions intended to prevent or treat COVID-19, including vaccines,…
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.…
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…
FDA Drug Approval and the Ethics of Desperation
In justifying the accelerated approval of aducanumab (Aduhelm; Biogen), US Food and Drug Administration (FDA) officials emphasized that many patients with Alzheimer disease and their families “made it clear…
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…
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…
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…
Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed
The US Congress created the Breakthrough Therapy designation in 2012 to expedite drug development and review through efficient clinical trial design and intensive interaction with US Food and Drug Administration (FDA)…
Number of health workers open to COVID-19 vaccine doubled after FDA approval
Just over half of all healthcare workers at one health system said they would receive the COVID-19 vaccine, but that number increased to more than 80% once the shots were cleared…
Tracking an FDA advisory panel’s meeting on J&J’s Covid-19 vaccine
A panel of outside experts is meeting Friday for a third time to consider whether the Food and Drug Administration ought to give an emergency use authorization for a Covid-19…
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…
The Lost Decade: Clinical Trials Data Access After Seife v HHS
Realization of the full value of data from clinical trials requires that the data be accessible to the broader research community, not just to the investigators who conducted and the…
The limits of acceptable political influence over the FDA
Extensive involvement of the White House in decision-making about the COVID-19 pandemic by the US Food and Drug Administration (FDA) has renewed attention to questions about the agency’s…
Problems With Paying People to Be Vaccinated Against COVID-19
The US Food and Drug Administration has issued Emergency Use Authorization for 2 vaccines for the prevention of coronavirus disease 2019 (COVID-19). This impressive scientific achievement paves the way to ending the…
Now That COVID-19 Vaccines Are Here, So Is the Prospect of Digital Immunity Passports
This week, the first doses of the Pfizer COVID-19 vaccine were administered in the U.S. With the FDA expected to approve Moderna’s vaccine imminently, people are already…
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…
FDA gene therapy holdups suggest closer scrutiny by agency
The Food and Drug Administration cleared the first two gene therapies for inherited diseases in short order, with just a year and a half separating historic approvals for the blindness…
Podcasts now available! 2020 Petrie-Flom Center Annual Conference: Innovation and Protection: The Future of Medical Device Regulation
Notice of Revision In light of developments with COVID-19, we converted our annual conference into a series of podcasts interviewing our contributors.Check out the episodes on This Week in…
The need for a system view to regulate artificial intelligence/machine learning-based software as medical device
Abstract Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized…
Right to Try: A ‘well-intentioned’ but ‘misguided’ law
[...] “On its face, it seems as though Right to Try would streamline the process and make it easier for patients, but actually, the FDA approves almost all the requests…
The FDA has officially raised the age to buy tobacco products to 21: The move could save thousands of lives.
The US Food and Drug Administration has officially raised the minimum age to buy tobacco products like cigarettes, electronic cigarettes, and vaping products that contain nicotine from 18 to 21. After President…
Lawmakers seek to loosen US FDA drug approval requirements to allow early access
From the article: Making products available under a conditional approval may result in some companies having difficulty enrolling patients in well-controlled phase 3 trials, Holly Fernandez Lynch, assistant professor of medical…
Medical Device Failures Brought To Light Now Bolster Lawsuits And Research
[...] For almost 20 years, malfunctions and injuries linked to 108 medical devices, including dental implants and pacemaker leads, were funneled into an FDA database that few patients, doctors or even FDA officials…
Why the Medicine You Take Could Actually be Bad for Your Health
From the article: Premature birth can be terrifying. Although survival rates for babies born before 37 weeks of pregnancy have steadily improved, they are still significantly worse than those of babies…
Biomarkers in Cancer Drug Approvals: New Opportunities and Challenges: A Health Policy and Bioethics Consortium
The FDA recently approved Keytruda and Vitrakvi, two cancer drugs targeting biomarkers without reference to the site of the disease. Defining cancer in terms of biomarkers alone may require us…
How Vaping Snuck Up On Regulators
[...] What's taken regulators so long? The passage of the Tobacco Control Act required the FDA to build an entire new regulatory infrastructure from scratch, and it faced numerous lawsuits…
FDA admits it goofed when granting orphan status to an opioid addiction treatment
In an unusual move, the Food and Drug Administration has acknowledged a mistake and revoked orphan drug status for an opioid addiction treatment that was approved two years ago, clearing…
Trump bets on Washington outsider to lead FDA amid political battles: The longtime cancer researcher will have a large role in Trump's agenda on vaping, drug prices and opioids.
President Donald Trump is betting on a Washington outsider to navigate a series of hot-button health care issues at the center of his 2020 campaign: a vaping crisis, an ambitious plan…
The Past and Future of Tobacco Regulation: A Health Policy and Bioethics Consortium
Description After decades of efforts to better regulate the sale of tobacco products, the U.S. has finally seen reductions in overall smoking levels. However, new dangers emerging from growing…
Book Launch: Transparency in Health and Health Care in the United States
Description In June 2019, Cambridge University Press published Transparency in Health and Health Care in the United States. This volume, edited by Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and…
Novartis’ new $2.1 million drug has roots in Philadelphia: Here’s how the city has impacted treatment of rare diseases
From the article: Approved just last month, Zolgensma is a onetime treatment for children under age 2. It uses a specially engineered virus called a vector — pioneered at Penn —…
Scientific Merit Predicates Ethical Review of Clinical Research
From the article: In the United States, federal regulations codified by the Department of Health and Human Services in the “Common Rule”1 address the conduct and oversight of…
2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies
Couldn't join us for the conference? Join the conversation on Twitter with #DTCgenome! And check out many of our speakers' slide presentations and our "Consuming Genetics" blog symposium! The…
Tackling high Rx prices
From the article: A new course launched this year on the HarvardX online platform, “The FDA and Prescription Drugs: Current Controversies in Context,” provides a free opportunity to…
Could food safety be improved if FDA had more independence?
From the article: Here’s a quick thought experiment: What if the FDA operated more like the CIA? That’s not a suggestion that the agency engage in…
When science and politics collide: Enhancing the FDA
From the article: For the better part of a century, the U.S. Food and Drug Administration (FDA) preserved public health by rigorously applying the scientific method. The central tenet…
Can Ethical Labeling Make Food Systems Healthy, Sustainable, and Just?: Lessons from a Critical Evaluation of the Democratic Governance Capacity of Animal Welfare Labeling
Description In this talk, Professor Christine Parker critically investigated the role of food labeling and its contestation as a governance pathway towards healthy, sustainable, and fair food systems. Consumers are…
Rx Drug Policy At The FDA: Looking Back At Gottlieb And Ahead To Sharpless
From the article: This week is expected to be Dr. Scott Gottlieb’s last as Commissioner of the U.S. Food and Drug Administration (FDA). During his nearly two…
Drug Companies and Doctors Battle Over the Future of Fecal Transplants
From the article: "CAMBRIDGE, Mass. — There’s a new war raging in health care, with hundreds of millions of dollars at stake and thousands of lives in the…
New treatments for peanut allergies sound promising, but questions remain
From the article: "What’s new is the addition of labor, standardization and federal oversight — which companies then say demonstrates increased value. It highlights a pattern I&rsquo…
New treatments for peanut allergies sound promising, but questions remain
From the article: "What’s new is the addition of labor, standardization and federal oversight — which companies then say demonstrates increased value. It highlights a pattern I&rsquo…
Seventh Annual Health Law Year in P/Review
Description At the Seventh Annual Health Law Year in P/Review symposium, leading experts discussed major developments during 2018 and what to watch out for in 2019. Speakers covered hot topics including…
Transparency in Health and Health Care in the United States
Read the full introduction online now! This edited volume stems from the Petrie-Flom Center’s 2017 annual conference, which brought together leading experts to reach better understandings of this health…
Drug Pricing Policies in the United States and Globally: From Development to Delivery
Couldn't join us? Check out the conversation on Twitter: @PetrieFlom #drugpricing and some of our speakers' slide presentations below! Description This one-day conference explored the current pharmaceutical pricing landscape…
Advance notice of mysterious rule puts drug-pricing people on edge
From the article: Holly Fernandez Lynch, a medical ethicist at the University of Pennsylvania, wonders whether FDA will audit third-party invoices to make sure manufacturers aren’t profiting from…
Trump Administration Wants TV Drug Ads To Include A Price
From the article: Rachel Sachs, an associate professor of law and a drug regulation expert at Washington University, said that the proposal is very narrow and doesn’t do…
5 questions on the Trump admin’s bid to mandate prices in drug ads
From the article: HHS argues that it has the authority to require price disclosures in ads through the Social Security Act, which tasks it with the "efficient" administration of the…
Trump issues rule to require drug prices in TV ads, rejecting industry plan
From the article: A majority of voters tends to support the transparency move but remains skeptical of whether it will lead to lower drug costs. A July POLITICO/Harvard poll…
Should TV Drug Ads Be Forced To Include A Price? Trump’s Team Says Yes
From the article: "It is noteworthy that the government is unwilling to take enforcement action," said Rachel Sachs, an associate professor of law at Washington University in St. Louis and…
Pharma’s new plan to put more info — but not drug list prices — in TV ads
From the article: Policy experts were already unimpressed with the Trump administration’s idea of requiring list prices to be included in ads, mostly because there is no real…
Drugmakers may have to disclose prices of medicine in television ads
From the article: Rachel Sachs, an associate professor of law at Washington University in St. Louis School of Law, said that it is unclear how or why disclosures would reduce…
Drugmakers may have to disclose prices of medicine in television ads
From the article: Rachel Sachs, an associate professor of law at Washington University in St. Louis School of Law, said that it is unclear how or why disclosures would reduce…
Bad Blood: Secrets and Lies in a Silicon Valley Startup: A Special Evening with Author John Carreyrou
This event featured moderated discussion with John Carreyrou, investigative reporter for the Wall Street Journal and author of the New York Times bestseller Bad Blood: Secrets and Lies in a…
Yes, PTAB proceedings against Orange Book patents are on the up. No, they’re not wiping them out
From the article: Further data has emerged showing that the Patent Trial and Appeal Board (PTAB) is far from the “death squad” that many in the US life…
Smart pills can transmit data to your doctors, but what about privacy?
From the article: Abilify MyCite, a pill-app combination that can be used to track the ingestion of drugs for bipolar disorder and schizophrenia, was the first such product approved by…
Call for Abstracts: 2019 Petrie-Flom Center Annual Conference: Consuming Genetics, Petrie-Flom Center, Harvard Law School
The call for abstracts for the 2019 annual conference is now closed. The conference agenda will be posted in late fall 2018 to the conference website. May 17, 2019 The Petrie-Flom Center for Health…
Health Law Workshop: Timothy Caulfield
Presentation Download the Presentation: "Health Misinformation and the Power of Narrative Messaging in the Public Sphere" Background Reading: Timothy Caulfield, "Elle Macpherson, 'anti-vaxx' nonsense, and the opportunity to engage," BMJ (2018). …
FDA confronts its limits in push on drug pricing
From the article: Drugmakers like AbbVie, which makes the best-selling biologic Humira (adalimumab), have reached settlement deals with makers of approved biosimilars to push off market entry. In the case…
Drug Prices in Ads: Senate Passes Amendment
From the article: Earlier this month, CMS also announced plans to begin using what’s called step therapy to try to lower the spend on Part B drugs by…
Report blames gaming of patent system for high drug prices: Most drugs named are biologics, and manufacturing trade secrets make competition especially tricky, legal expert says.
[...] The report, “Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices,” was released last week by the nonprofit Initiative for Medicines, Access and…
Administering Health Innovation
From the article: Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and…
Drug Approval in a Learning Health System
From the abstract: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA — and…
Drug Approval in a Learning Health System
From the article: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and…
Unpacking the bold — and the bluster — in Trump’s plan to bring down drug prices
From the article: The administration says the proposal will save Medicare money, which could translate into lower premiums. It will also mean lower co-pays for any beneficiary who might need…
The Trump administration finally has one good idea to lower drug prices
From the article: Right now, in the above circumstances and when there isn’t an actual drug shortage, “we don’t have a good policy solution,”…
Update: UK Ministers Quit Over Brexit
From the interview: We consider the implications for Brexit as two senior UK ministers resign. David Henig is UK director of the European Centre For International Political Economy. He explains…
HHS forced to choose migrants over medicines
From the article: Echoing the pharma industry, Verma stressed that the state's request violated current law — the first time she's publicly cited a legal defense. “[I…
What Pfizer, Trump, and consumers got out of a surprising deal — and what they didn’t
From the article: After months of pledging he would get pharmaceutical companies to lower their prices, President Trump can now say that he pressed the CEO of a major drug…
The News on Drug Prices? Nothing Good
From the article: “It takes away a substantial tool that a lot of states were hoping to use,” says Rachel Sachs, a law professor and drug policy expert…
Donald Trump’s phony war on high prescription drug prices, explained
From the article: Pfizer ended up agreeing to postpone its price hikes for now. The president was happy to take credit for that news, even if all he had really…
Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics
From the webcast: Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will focus…
CMS quit test of pricey cancer treatment amid concerns over industry role
From the article: “Coming from an administration which has a stated goal of trying to reduce drug pricing, trying to reduce overall drug spending and health care spending ……
Viagra goes up AGAIN: Pfizer hikes the cost of 100 best-sellers a month after Trump said he'd persuaded Big Pharma to carry out 'massive' price drops
From the article: Economists are now calling on the Department of Health and Human Services to clarify what kind of measures they were planning on levying against companies that did…
Regulation of Stem Cell Therapy Travel
From the abstract: Purpose of Review Stem cell therapies (hereinafter: SCT) hold tremendous promise for the treatment of a variety of diseases. Yet, alongside the medical potential, they pose significant…
Tempering Expectations of Breakthrough Therapy Designated Drugs
From the interview: A recent study published in the Journal of Clinical Oncology (online June 20, 2018; doi:10.1200/JCO/2017.77.1592) sought to evaluate the United States Food and Drug Administration (FDA) breakthrough therapy…
Call for Proposals Enforcement, Litigation, and Compliance Conference, Food and Drug Law Institute
The annual Enforcement, Litigation, and Compliance Conference brings together industry, regulators, attorneys, litigators, academics, and consultants to discuss trends and issues in enforcement and compliance, the latest developments in both…
A Method for Approximating Future Entry of Generic Drugs
From the abstract: Objectives To develop and test a method for approximating generic entry of top-selling drugs. Methods The procedure involved 1) identifying products’ key patents as those with a…
Precision Medicines Approved More Quickly, With Less Data
From the article: Pivotal trials for precision medicines were scarcer, less likely to be controlled or blinded, and had fewer participants than those for other agents, the study found. The…
JAMA Forum: The Risks and Benefits of Expedited Drug Reviews
From the article: The US Food and Drug Administration (FDA) oversees several programs that expedite approval of certain drugs that treat serious conditions and address unmet medical needs. On average,…
Trump unveils plan to cut drug prices
From the article: A trade association that represents PBMs disagrees. Eliminating rebates would leave patients and insurers “at the mercy of drug manufacturer pricing strategies”, according to a…
Trump Wants Medicaid to Push for Lower Drug Prices – But Will Patients Be Hurt?
From the article: While 74 percent of closed formularies result in lower prices, 21 percent result in price increases, a 2016 report in the American Journal of Managed Care found. And 29 percent of…
Vermont legislators pass a drug importation law. So what?
From the article: Importation backers — including the National Academy for State Health Policy (NASHP), which helped craft Vermont’s bill and has worked with state lawmakers — hope…
Criticism of ‘right to try’ law for experimental drugs after it passes in US
From the article: The US government has controversially announced that it will allow unapproved, experimental drugs to be given to terminally ill patients. The ‘right to try’ law…