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Total 341 results found since Jan 2013.
Shire Settles Claims of Deceptive Marketing of Multiple Drugs for $56.8 Million, No Individual Held Responsible
Here we go again. A big drug company has settled claims of deceptive marketing, yet no individual was held accountable. The most extensive coverage came from the Philadelphia Inquirer, presumably since the announcement came from the local US Attorney.The basics were:Shire Pharmaceuticals L.L.C. will pay $56.5 million to settle allegations that it inappropriately promoted the sale of ADHD medicine, among other drugs, the U.S. Attorney's Office in Philadelphia said Wednesday.Shire is registered in the Channel Islands and headquartered in Dublin, but operates from the United States....As is usual in such cases,Shi...
Source: Health Care Renewal - September 26, 2014 Category: Health Management Tags: corporate integrity agreement deception legal settlements marketing Shire US Department of Justice Source Type: blogs
“Stand Up To Cancer” Not Standing Up to Cigarette Promoters; Special Guest Commentary by Dr. Alan Blum
Tuscaloosa, AL, September 4, 2014--Several of the sponsors of this Friday’s “Stand Up To Cancer” national fundraising telethon are doing more to promote cigarette companies than to prevent or cure cancer, according to an analysis of the organization behind the event by a physician and veteran anti-cancer advocate at The University of Alabama. “This effort to solicit money for cancer research is compromised by the inclusion of corporations and foundations closely allied with the manufacturers of cigarettes, the nation’s leading avoidable cause of cancer,” said Alan Blum, MD, professor of Family Medicine and Dire...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - September 15, 2014 Category: Addiction Source Type: blogs
Biosimilars Update: FDA Releases “Purple Book”; Two Companies File Biosimilar Applications, Industry Responds to Draft Guidance
Vaccines, allergy shots, blood components, and gene therapies are examples of biological products. Most biologics are produced in living organisms, such as plant or animal cells, whereas small molecule drugs (most pharmaceuticals) are typically manufactured through chemical synthesis. The inherently complex nature of biologics makes them expensive to develop and impossible to copy in the manner traditionally associated with the approval of generic drugs.
BioSIMILAR, not BioEQUIVALENT
Enter “biosimilars,” which the Food and Drug Administration (FDA) defines as biological products that are highly similar to an already ap...
Source: Policy and Medicine - September 15, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
New Health Policy Brief: Drug Shortages
A new Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) looks at the ongoing problem of drug shortages in the United States. From 2005 to 2010, the number of reported drug shortages almost tripled.
Today, newly reported drug shortages overall are decreasing, but the total amount of drug shortages continues to increase, reflecting just how long it can take to rectify a shortage. Generic sterile injectable drugs, a vital component for patients fighting cancer, combatting an infection, or about to undergo surgery, are in especially short supply.
One of the most cited reasons for generic ste...
Source: Health Affairs Blog - September 11, 2014 Category: Health Management Authors: Tracy Gnadinger Tags: All Categories Consumers Pharma Policy Source Type: blogs
PhRMA Proposes “Early Review” System for Reserving Proprietary Names to FDA
The Food and Drug Administration (FDA) recently invited public comment on plans to allow pharmaceutical companies to reserve proprietary names as early as the end of Phase II trials. According to Regulatory Focus, FDA has posted the Pharmaceutical Research and Manufacturers of America’s (PhRMA) proposal to its public docket, offering the public a glimpse at what could become the basis for the future drug name reservation system. The document can be found here. We previously wrote about FDA guidance and proprietary drug naming here.
Background
Regulatory Focus previously provided a succinct explanation of this drug naming...
Source: Policy and Medicine - September 10, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Rescue Me: The Challenge Of Compassionate Use In The Social Media Era
TweetThe Development of Brincidofovir And Its Possible Use To Treat Josh Hardy
Last March 4, seven-year old Josh Hardy lay critically ill in the intensive care unit at St Jude Children’s Hospital in Memphis, Tennessee with a life-threatening adenovirus infection. His weakened immune system was unable to control the infection, a complication of a bone marrow stem cell transplant he needed as a result of treatments for several different cancers since he was 9 months old.
His physicians tried to treat the adenovirus with an anti-viral agent, Vistide (IV cidofovir), but had to stop due to dialysis-dependent renal failure. Th...
Source: Health Affairs Blog - August 27, 2014 Category: Health Management Authors: Arthur Caplan and Kenneth Moch Tags: Access All Categories Bioethics Biotech Consumers Pharma Policy Research Technology Source Type: blogs
Senate Appropriations Committee "Concerned" That FDA Has Not Consulted With Stakeholders Before Releasing Guidance
As reported by The Hill, earlier this year, the Senate Appropriations Committee told the Food and Drug Administration (FDA) to reach out to stakeholders such as physicians, patients and pharmacists before releasing new guidances for compounding pharmacies. Under the 2013 Compounding Quality Act, the FDA has greater oversight and funding to regulate compounding pharmacies. However, in a new report, the committee is also requiring the agency to meet with stakeholders before issuing further guidances. According to Sen. Lamar Alexander (R-Tenn.), the committee's ranking member, physicians, patients and pharmacists have...
Source: Policy and Medicine - August 22, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Move Along, No Health Care Corruption to See Here
Health care corruption, remains a largely taboo topic, especially when it occurs in developed countries like the US. Searching PubMed or major medical and health care journals at best will reveal a few articles on health care corruption, nearly all about corruption somewhere else than the authors' countries, usually in someplace much poorer. While the media may publish stories about issues related to health care corruption, they are almost never so labelled.Yet Transparency International's report on global health care corruption suggested it occurs in all countries. A recent TI survey showed that 43% of U...
Source: Health Care Renewal - August 21, 2014 Category: Health Management Tags: bribery Cancer Research and Prevention Institute complementary/ alternative medicine health care corruption Source Type: blogs
FDA ANDA Submissions Content and Format of Abbreviated New Drug Applications
Recently, the US Food and Drug Administration (FDA) released a new draft guidance document on the content and format of generic drug submissions using the common technical document (CTD).
As reported, FDA's new draft guidance document, ANDA Submissions — Content and Format of Abbreviated New Drug Applications, is meant to help industry increase the quality of its submissions, the agency said in a Federal Register notice. The agency's hope is that by helping industry to increase submission quality, it can help it to meet the agency's obligations under the Generic Drug User Fee Act (GDUFA), which r...
Source: Policy and Medicine - August 18, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
The cruel sham of “right to try” comes to Michigan
There are times when supporting science-based health policy and opposing health policies that sound compassionate but are not are easily portrayed as though I’m opposing mom, apple pie, and the American flag. One such type of misguided policy that I’ve opposed is a category of bills that have been finding their way into state legislatures…
Source: Respectful Insolence - August 14, 2014 Category: Surgery Authors: Orac Tags: Bioethics Cancer Clinical trials Medicine Politics Science Skepticism/critical thinking Abigail Alliance Arizona Arlene Kalley colorado Food and Drug Administration Goldwater Institute John Pappageorge< Kefauver-Harris Amendmen Source Type: blogs
Antitrust Lawsuit Against Celgene Over Thalomid and Revlimid Focuses on REMS Requirements
Celgene's successful cancer drugs Thalomid and Revlimid are at the center of an antitrust action. On April 3rd, Mylan Pharmaceuticals Inc. filed an antitrust lawsuit against Celgene Corporation in the U.S. District Court of New Jersey, accusing Celgene of blocking generic competition from Thalomid and Revlimid. Mylan accused Celgene of abusing their FDA Risk Evaluation and Mitigation Strategy requirements in order to monopolize the cancer drug market.
As a background, in 2007, the Food and Drug Administration Amendments Act (FDAAA) gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from man...
Source: Policy and Medicine - August 14, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
Dr. Frances Oldham Kelsey is 100
Happy 100th birthday to Dr. Frances Oldham Kelsey, the pharmacologist whose bold stance against inadequate drug testing saved countless newborns from the perils of thalidomide, a drug which caused severe birth defects in over 10,000 infants. On her first month on the job at the U.S. Food and Drug Administration in 1960, the Canadian-born scientist resisted pressure from thalidomide's manufacturer to quickly approve the drug, which was already being widely prescribed in Europe as a painkiller for pregnant women. As a result of Dr. Kelsey's insistence on further safety testing, the drug was never approved in the US, saving a...
Source: PharmaGossip - July 25, 2014 Category: Pharma Commentators Authors: insider Source Type: blogs
FDA Guidance Balancing Premarket and Postmarket Data Collection for Devices
In releasing guidance entitled, "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval - Draft Guidance for Industry and Food and Drug Administration Staff," FDA attempts to clarify current policy on balancing premarket and postmarket data collection during the Agency's review of premarket approval applications (PMAs).
Comments and suggestions regarding the draft document are due by July 22, 2014. Submit electronic comments to http://www.regulations.gov/. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers L...
Source: Policy and Medicine - July 21, 2014 Category: American Health Authors: Thomas Sullivan Source Type: blogs
The Texas Medical Board vs. Stanislaw Burzynski, Round Infinity
There’s a point I feel that I have have to make briefly as I begin this post. Basically, this might look familiar, but given that I was at TAM Wednesday through Sunday, I didn’t have time to produce two separate posts, and this is important enough to be distributed as widely as possible. In any…
Source: Respectful Insolence - July 14, 2014 Category: Surgery Authors: Orac Tags: Cancer Clinical trials Complementary and alternative medicine Politics Quackery antineoplaston Food and Drug Administration Stanislaw Burzynski Texas Medical Board Source Type: blogs
