FDA Fact Sheet For Recipients And Caregivers

 Fact Sheet For Recipients And Caregivers:  EUA Of The Pfizer-Biontech Covid-19 Vaccine.  Food and Drug Administration

Trump, Without Evidence, Accuses FDA Of Delaying Coronavirus Vaccine Trials And Pressures Agency Chief

Trump, Without Evidence, Accuses FDA Of Delaying Coronavirus Vaccine Trials And Pressures Agency Chief by Veronica Stracqualursi.  CNN.  August 22, 2020.

Evaluating New Drugs Is About To Take A Step Backward

When Cancer Treatments Do More Harm Than Good by Cary Gross.  The Washington Post.  February 24, 2017. 

FDA Candidate Wants To Eliminate Agency Guarantee That New Drugs Are Effective

Trump Considers Naming FDA Chief Who Would Radically Overhaul The Agency by Sheila Kaplan.  Stat.  December 7, 2016

21st Century Cures Act Raises Concerns About FDA Approval Process

21St Century Cures Act Will Distort The Meaning Of 'FDA Approved' by Reshma Ramachandran And Zackary Berger.  December 1, 2016

Wearable Robotic Skeleton Approved By FDA; Could Potentially Benefit 1.7 Million In The U.S.

Parker Hannifin's Robotic Exoskeleton Gets FDA OK For Personal Use by Bob Tita.  The Wall Street Journal.  March 10, 2016

FDA To Review Use Of The Term "Natural" On Food Labels

Surprise:  FDA To Review Use Of "Natural" Food Claim by Karlene Lukovitz.  Marketing Daily.  November 11, 2015. 

F.D.A. Use Of The Term "Breakthrough" Drug Has A Specific Meaning Which May Lead To Confusion

"Breakthrough" Drug May Not Mean What You Think by Kathryn Doyle.  Reuters.  September 21, 2015. 

FDA Approved Authoritative Blood Test Outside A Lab

A Second FDA Approval Frees Theranos To Do A Blood Test Outside Lab by Roger Parloff.  Fortune.  July 16, 2015

FDA Approves Copy Of Biologic Drug, Possibly Leading To Dramatically Lower Costs On Medicines Produced In Living Cells

FDA Approves First Lower-Cost Biotech Drug by Matthew Perrone and Linda A. Johnson.  AP/ABC News.  March 6, 2015. 

FDA-Approved Labeling Provides Shield For Generic Drug Makers Even When Side Effects Discovered

Supreme Court:  Generic-Drug Makers Can't Be Sued Under State Law For Design Defects by Lawrence Hurley and Bill Berkrot.  Washington Post.  June 24, 2013.

(1)  About _________% of U.S. prescriptions are filled with generics.

(2)  According to the majority opinion, _______________ could not run against federals laws on labeling prescription medicines whose design has been approved by the FDA.

(3)  A 2011 Court ruling found that branded drugs are ____________ while makers of generics ________.

(4)  The Court agreed that federal law requires generic drugs to the same_______________________.

(5)  What happens under the ruling if a dangerous side effect of the medicine does not come to light until long after it was approved by the FDA and perhaps there is no branded label on the market?

FDA Warns About Cyberattack Vulnerability Against Medical Devices And Hospital Networks

FDA Warns About Risk Of Cyberattacks On Medical Equipment, Hospital Networks by Rachel Landen.  Modern Healthcare.com.  June 14, 2013.

(1)  The Food and Drug Administration asked device manufacturers and healthcare facilities to introduce ______________ to guard against cyberattacks.

(2)  One reason that devices are at risk of infection is that many of them connect ______________.

(3)  A representative of the Advanced Medical Technology Association said that _______________
had resulted from cybersecurity breaches.

(4)  Among the steps the FDA is recommending are _____________________________________
______________________________________________________________________________.

(5)  The FDA's security reporting program is ____________________.

The Girl Who turned To Bone

The Mystery Of The Second Skeleton by Carl Zimmer.  The Atlantic.  June 2013.

(1)  What is fibrodysplasia ossificans progressive (FOP)?  Describe by symptom.  Describe by genetics.  Describe by how it progresses.

(2)  A rare disease is defined as ___________________________________.
More than ___________ such diseases exist, affecting ______ million to ________ million.

(3)  Most people with FOP are born with a _______________.

(4)  A rare disease is a natural __________________.

(5)  How could study of FOP affect future treatments for osteoporosis?

(6)  What is Tangier disease and how could it lead to more effective treatment of heart disease?

(7)  The NIH program, Therapeutics for Rare and Neglected Disease, collaborates with scientists to ________________________________________________.

(8)  How has the FDA smoothed out the approval process for drugs for rare diseases?  

Data Mining Of Internet Search Data Provides Clues To Unforeseen Side Effects

Search Engine Data Gives Early Warning Of Drug Side Effects by Sciencenow.  Wired.  March 7, 2013.

Unreported Side Effects Of Drugs Are Found Using Internet Search Data, Study Finds by John Markoff.  The New York Times.  March 6, 2013.

This "Big Data" tool, using millions of search engine results could be a new tool to spot drug side effects that may have escaped notice in clinical trials and FDA investigations.  The FDA instituted a program in 2008 that plans to monitor drug use by as many as 100 million people in the United States.

Orphan Drugs No Longer Unloved

Drug Makers See Profit Potential In Rare Diseases by Jonathan D. Rockoff.  The Wall Street Journal.  January 30, 2013.

Drugs designed to treat rare diseases were once neglected as unprofitable by pharmaceutical companies.    This article presents several drugs that show that this is no longer the case.  Incentives from the FDA include quicker approval, tax benefits, and protection from competition make this class of products quite attractive.   Also, the narrow genetic focus of these drugs also makes unnecessary, large-scale and expensive clinical trials.  This drugs also often have astronomical prices--often covered by insurance-- making them a very profitable contributor to pharmaceutical companies revenue.

WebMD 2012 Year In Health

2012 Year in Health:  WebMD's Top Health Stories Of The Year.  WebMD.

Among the stories mentioned  are (1) Health reform law upheld by Supreme Court;  (2) Diet drugs approved by the FDA to address the obesity crisis;  (3) Dreaded diseases including West Nile, hantavirus, plague, and flesh-eating bacteria;  (4) The PSA for prostate cancer was ruled not needed by the U.S. Preventative Services Task Force; (5) Fungal meningitis outbreak from steroid injections  (6) Sitting found to be a health risk;  (7)  Excedrin, Bufferin, NoDoz, Gas-X recalled for production and potential mixing with prescription painkillers;   (8)  Designer drugs such as bath salts;  (9) Children facing adult health problems because of obesity;  (9) Tainted food and issues with energy drinks.

Drug Promotion Ruling Could Be Major Landmark

Off-Label Drug Marketing Is 'Free Speech,' Court Rules by John Fauber.  Milkaukee Journal Sentinel/MedPage Today.  ABC News.  December 5, 2012.

The FDA rules governing pharmaceutical company promotion of drugs may have been significantly changed.   The broad impact of  the decision by the Second Circuit Court of Appeals in New York awaits determination by the U.S. Supreme Court.

Under FDA rules,  pharmaceutical companies can only promote a drug for an FDA-approved use.  As a result of the Second Circuit decision, the limited focus of pharmaceutical companies' promotion effort has greatly broadened, encompassing promotion of "off-label" uses of the drug.  The article addresses the "free-speech" rationale for the decision as well as the public health, and safety implications of the ruling.

FDA Probes Health And Energy Drink Link

FDA Probes Whether Deaths Linked To Energy Shots by Elizabeth Weise and Jayne O'Donnell.  USA Today.

At issue are 13 reports of deaths and 33 hospitalizations associated with highly caffeinated shots often sold in convenience stores.  Due to the fact that energy drinks are classified as dietary supplements they are not regulated by the F.D.A and the amount of caffeine is often not known or inaccurately reported according to experts cited in the story.   Soft drinks, by contrast, are regulated and must have no more than 71.5 milligrams of caffeine in a 12-ounce serving.  An expert in caffeine toxicity listed among its possible symptoms cardiac arrhythmia, and psychotic episodes.  The question of what the F.D.A. should do in response is the emphasis of this story.

Quality Control Issues and Drugs Manufacturers

Lapses at Big Drug Factories Add to Shortages and Danger by Katie Thomas.  The New York Times.  October 17, 2012.

This article puts forward the idea that drug safety issues extend far beyond the compounding pharmacy involved in the current outbreak of meningitis.  While manufacturers reject the notion that production quality is deteriorating, there are areas of concern cited by the article. For example a congressional report claims that a third of the pharmaceutical manufacturing capacity is off line due to quality issues.  Industry spokesmen cite continuing efforts to improve operations and safety in response to FDA concerns.