Flowers, chocolates, organ donation — are you in?
Chocolates and flowers are great gifts for Valentine’s Day. But what if the gifts we give this year could be truly life-changing? A gift that could save someone’s life, or free them from dialysis?
You can do this. For people in need of organ, tissue, or blood donation, a donor can give them a gift that exceeds the value of anything that you can buy. That’s why February 14th is not only Valentine’s Day — it’s also National Donor Day, a time when health organizations nationwide sponsor blood drives and sign-ups for organ and tissue donation. Read on if you’ve ever wondered what can be donated, had reservations ...
Source: Harvard Health Blog - February 11, 2021 Category: Consumer Health News Authors: Robert H. Shmerling, MD Tags: Health Heart Health Kidney and urinary tract Lung disease Source Type: blogs
Increasing Access to Biosimilar Drugs
The development of ‘specialty drugs’
in the health care industry has created legal, ethical, and public policy
issues because patients are not able to get access to their prescribed
medications based on the expense. Specialty
drugs are usually biologicals, treat serious conditions, and are very expensive with no cheap
alternatives.[1] Although there is debate
about how much finances should influence medical decision making, it is a
conversation that can not be ignored when patients can not get access to
treatment based on ability to pay. There should be increased access to these
drugs but how to inc...
Source: blog.bioethics.net - May 1, 2017 Category: Medical Ethics Authors: Bioethics Today Tags: Health Care Justice Pharmaceuticals Drug fairness Pharmacy Ethics syndicated Source Type: blogs
Memo To The President: The Pharmaceutical Monopoly Adjustment Act Of 2017
Since 1980, Congress has enacted many laws granting pharmaceutical manufacturers monopolies that no other industry enjoys. These extra monopolies were created with the expectation that monopoly profits would spur greater investment in research to find important new drugs. In fact, they have caused US consumers to pay higher prices for medicines for longer periods of time while making the pharmaceutical industry far more profitable than any other industry. I believe the next president and Congress should take several key steps, which I outline below, to roll back these costly, unnecessary monopolies.
The Current Landscape
C...
Source: Health Affairs Blog - September 13, 2016 Category: Health Management Authors: Alfred Engelberg Tags: Costs and Spending Drugs and Medical Technology Health Policy Lab Bayh-Dole Act Big Pharma Gilead Hatch-Waxman Act johnson & johnson pfizer Source Type: blogs
Fight Aging! Newsletter, June 13th 2016
FIGHT AGING! NEWSLETTER
June 13th 2016
Fight Aging! provides a weekly digest of news and commentary for thousands of subscribers interested in the latest longevity science: progress towards the medical control of aging in order to prevent age-related frailty, suffering, and disease, as well as improvements in the present understanding of what works and what doesn't work when it comes to extending healthy life. Expect to see summaries of recent advances in medical research, news from the scientific community, advocacy and fundraising initiatives to help speed work on the repair and reversal of aging, links to ...
Source: Fight Aging! - June 12, 2016 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs
Immune System Destruction and Recreation Can Cure Multiple Sclerosis
The latest update for ongoing efforts to test destruction and recreation of the immune system in patients suffering from the autoimmune disease multiple sclerosis demonstrate that this approach is effectively a cure if the initial destruction of immune cells is comprehensive enough. Researchers have been able to suppress or kill much of the immune system and then repopulate it with new cells for about as long as the modern stem cell therapy industry has been underway, something like fifteen years or so. Methodologies have improved, but the destructive side of this process remains unpleasant and risky, something you wouldn'...
Source: Fight Aging! - June 9, 2016 Category: Research Authors: Reason Tags: Medicine, Biotech, Research Source Type: blogs
IMS Releases 2016 Report on Prescription Drug Spending – Net Price Growth 2.8% in 2015
Discussion on Medicare Part B Drug Payment Model Demonstration (Source: Policy and Medicine)
Source: Policy and Medicine - May 1, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Top Policy and Medicine Stories for 2015
At the end of each year, we attempt to give you an overview of what happened in previous year and give some spin on predictions for the coming year, much like an end-of-the-year family newsletter. For those who are a bit more nostalgic, here is a link to our 2014 story.
Perhaps the End of Off Label Lawsuits?
With the Amarin Injunction, Caronia standing for two years without any pushback from the government, and the recent settlement with Pacira, there seems to be a trend of the FDA pulling away from off-label citations. Perhaps this trend is a signal of the end of cases against manufacturers for off label pr...
Source: Policy and Medicine - December 30, 2015 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Be Careful What You Wish For? FDA’s Biosimilars Naming Guidance Proposes New Identifiers For All Biologic Products
Yesterday, the Food and Drug Administration (FDA) released much anticipated guidance on how they plan to address nonproprietary naming of biologics and biosimilars. In it, FDA proposed that all biologics—both reference products and biosimilars—will share a core drug substance name and also a new “FDA-designated suffix” that is unique for each product. While brand-biologic manufacturers pressed FDA to ensure biosimilars carry unique names, the agency’s proposal in fact places a large burden on these manufacturers and prescribers to adopt the new naming model.
In March, FDA approved the fir...
Source: Policy and Medicine - August 28, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Biosimilars: Abbvie Finds Fault with Zarxio Label, Submits Citizen Petition
Conclusion
AbbVie's citizen petition challenges important considerations surrounding the labeling of biosimilars. The labeling protocol the FDA used was the same one they typically use for generic drugs.
Another problem with the labeling, this one for biosimilar manufacturers in the Zarxio label is that none of the clinical or analytical data that supported the finding of bio similarity to the reference product is included in the label, which will put biosimilars at a disadvantage when they go to detail the product to physicians, pharmacists and payers. Much of what they would talk about for a branded drug will be...
Source: Policy and Medicine - June 4, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Acting Commissioner Ostroff Addresses the "State of the FDA"
The 2015 FDLI Annual Conference kicked off yesterday in Washington, DC. The conference hosted a variety of impressive speakers from the Food and Drug Administration, as well as FDA lawyers and in-house counsel. Dr. Stephen Ostroff, the Acting Commissioner at FDA, spoke as the conference's keynote speaker. After congratulating previous Commissioner Margaret Hamburg on an impressive tenure as FDA Commissioner, Ostroff ran through a long list of recent FDA accomplishments--"hitting the highlights," as he called it. Following Ostroff's address, a panel of industry experts provided a "to do list" for the agency for the co...
Source: Policy and Medicine - April 21, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Public Citizen Urges FDA To Penalize Drug Makers Over Diabetes Ads, Criticizes the Agency’s “Dismal Record” on Issuing Warning Letters
Consumer advocacy group Public Citizen is calling on the Food and Drug Administration (FDA) to “stop the apparently violative off-label promotional statements” in various Type 2 Diabetes advertisements, which the group argues are being advertised as weight-loss drugs. “[N]one of the drugs is approved for weight loss and, despite the presence of disclaimers that the medications are not weight-loss drugs, the implication is clearly that weight loss is an additional potential benefit of the drugs,” Public Citizen states.
This request comes in the midst of a “drastic reduction” in the past few years of direct-to-co...
Source: Policy and Medicine - April 3, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
District Court Denies Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio
The first U.S. biosimilar is one step closer to entering the marketplace. Last week, U.S. District Judge Richard Seeborg of the Northern District of California denied Amgen's request for a preliminary injunction to block Sandoz from selling its version of Neupogen. The Food and Drug Administration approved Sandoz’s biosimilar application for “Zarxio” earlier this month.
Amgen had argued that Sandoz should have provided its Biologic License Application and manufacturing plans within 20 days after the FDA accepted the application, in accordance with the "patent dance" procedure laid out in the biosimilar statute....
Source: Policy and Medicine - March 24, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Approves Sandoz's Zarxio, The First Biosimilar Approved in the U.S.
Today, the Food and Drug Administration approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the U.S. Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. The approval comes two months after an FDA advisory committee recommended Zarxio as biosimilar to Neupogen for all five of the intended indications.
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product--in this case Neupogen. The biosimilar a...
Source: Policy and Medicine - March 6, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
FDA Postpones Advisory Committee Review of Celltrion's Remicade Biosimilar
Celltrion will have to wait longer than expected for FDA's Advisory Committee to review its application for Remsima, a biosimilar for Johnson and Johnsons’ Remicade (infliximab). Yesterday, FDA announced that they would be postponing the meeting of the Arthritis Advisory Committee scheduled for March 17, 2015 where they were going to review the product.
View FDA's announcement here.
"The postponement is due to information requests pending with the sponsor of the application. A future meeting date will be announced in the Federal Register," states the Agency.
The A...
Source: Policy and Medicine - February 26, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Orphan Drugs Had A Big 2014, Including Unprecedented Approval Rates
Recognizing that drug companies would actually incur a financial loss in developing important drugs for rare conditions, Congress passed the Orphan Drug Act in 1983. The Act offers incentives to induce companies to develop drugs and other medical products for the small markets of individuals with rare disorders, defined as diseases affecting fewer than 200,000 people in the U.S. Have these incentives worked?
This past week, FDA Law Blog ran some interesting analytics on orphan drug designations and approvals over the past year which suggest the answer is “Yes.”
Mostly using data culled from FDA’s Orphan D...
Source: Policy and Medicine - February 20, 2015 Category: American Health Authors: Thomas Sullivan Source Type: blogs
