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Category Archives: FDA Regulation

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Drugs Disapproved by the FDA Deserve Attention

Posted in Drug Studies, FDA Regulation, Public Health

Recently, Reuters reported that “Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness”. Reporter Lisa Rapaport quotes Dr. Peter Lurie, FDA associate commissioner for public health strategy and analysis, saying “‘Only a minority of the press… Continue Reading

2014 – FDA Recalls DePuy Craniomaxillofacial Distraction System, Cites Fatal Risk

Posted in Devices, FDA Regulation, Recalls

Recently, a craniofacial distraction implant by DePuy Orthopaedics was recalled.  This device, called the Craniomaxillofacial (CMF) Distraction System, “is a modular family of internal distraction devices that are used to gradually lengthen the mandible body and ramus” and indicated as “a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or posttraumatic… Continue Reading

Proposed Class-Action Lawsuit Filed Against Manufacturer & Distributor of OxyElite Pro

Posted in FDA Regulation, Lawsuits, Safety Alerts

A man by the name of Sandeep Barot has filed a proposed consumer protection class-action lawsuit against the manufacturer and distributor of dietary supplements that allegedly cause liver damage. See Barot v. USPLabs LLC et al., No. 1:14-cv-00562, complaint filed (D.N.J. Feb. 3, 2014). The defendant companies are USPLabs, LLC (“USPLabs”) and General Nutrition Center… Continue Reading

Generic Drug Industry Pushback Over New FDA Regulations

Posted in FDA Regulation

A recent article in the Los Angeles Times discusses industry pushback against proposed federal legislation that would allow the manufacturers of generic pharmaceutical drugs the ability to “inform people about all known health risks” associated with various drugs produced.  The Generic Pharmaceutical Association was quoted saying that the new regulations “would create ‘dangerous confusion’ and… Continue Reading

FDA Exerts New Authority over Compounding Pharmacies with Drug Quality and Security Act

Posted in FDA Regulation, Politics, Public Health

In the wake of the recent fungal meningitis outbreak that left 64 dead and infected some 751 Americans, traced back contaminated steroid injections from the New England Compounding Center (Framingham, MA), the United States Food and Drug Administration has sought greater oversight over the pharmacy compounding industry. To that end, Congress passed the Drug Quality… Continue Reading

FDA: Xarelto not to be approved for acute coronary syndrome

Posted in Drug Studies, FDA Regulation, Public Health

Yesterday (1/16/2014) Reuters reported that an FDA advisory panel rejected a call by Johnson and Johnson to approve their anticoagulant Xarelto (rivaroxaban) for acute coronary syndrome by a vote of 10-0 with one abstention. While Xarelto “is already used to treat and prevent deep vein thrombosis and pulmonary embolisms and to reduce the risk of… Continue Reading

2013 – “FDA lifts constraints on Glaxo diabetes drug Avandia”

Posted in Drug Studies, FDA Regulation

A recent article by Bill Berkrot and Ransdell Pierson (published in Reuters) reports on restrictions being lifted from the use of the drug Avandia.  Avandia is a diabetes drug made by the company GlaxoSmithKline that was thought to increase the risk for heart attacks for people using the drug.  The U.S. Food and Drug Administration… Continue Reading

New Federal Efforts to Curb Salmonella Outlined by FSIS

Posted in FDA Regulation

Salmonella is a food-borne bacteria, typically present in meat and poultry products.  An estimated 1.3 million illnesses can be attributed to Salmonella every year.  To address outbreaks of salmonella, the US Department of Agriculture’s (USDA) Food and Safety Inspection Service (FSIS) has released its Salmonella Action Plan that outlines the steps it will take to… Continue Reading

FBI Steps Up Defenses for Attacks on US Food Supply

Posted in FDA Regulation, Public Health

Ellen Beck recently wrote an article for the “Smart Blog on Food and Beverage” website titled “FBI Makes Threats to U.S. Food Supply a Bigger Priority”, that discusses the food industry’s vulnerability to intentional food contamination.  In light of all the terrorist attacks taking place throughout the world, the FBI is becoming increasingly concerned that… Continue Reading

FDA moves to ban trans fats – New York Times

Posted in FDA Regulation, Public Health

A November 7th New York Times article by Sabrina Tavernise discusses the recent FDA ruling surrounding trans fats. Nutrition is an ever-changing area of research.  Many of the guides to healthy cooking and eating methods once thought ideal are now seen to be quite unhealthy and harmful to our health.  During the 1950’s, 1960’s, and… Continue Reading

FDA finds Drug Quality and Security Act insufficient

Posted in FDA Regulation

Julian Hattem of RegWatch, a blog curated by TheHill, reports in a piece that the US Food and Drug Administration is “not sold” on a recent pharmacy compounding bill. The mixing and distributing of medications happens at various compound pharmacy clinics found all throughout the United States, and these compounding clinics have been the source… Continue Reading

FDA seeks more stringent controls for some pain medications

Posted in FDA Regulation, Public Health

According to a recent report by HealthToday.com, The U.S. Food and Drug Administration believes certain commonly-used drugs that should be more difficult to obtain.  Painkillers such as Lortab and Vicodin contain hydrocodone (a synthetic opiate) which is often abused and highly addictive; tighter controls on these types of prescriptions may be a good way to… Continue Reading

FDA won’t say which drugs on the market were approved based on fraudulent research

Posted in Drug Studies, FDA Regulation

This shows that the FDA is more interested in protecting pharmaceutical companies than patients.  Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk.  A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug.  And allowing any… Continue Reading

AAJ on Generic Preemption

Posted in FDA Regulation, Generic Drugs

Here’s a little more in-depth analysis of the generic drug argument before SCOTUS: Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process does… Continue Reading

FDA Launches New Website To Show Safety Information Of New Drugs

Posted in FDA Regulation

This is a great step towards greater transparency: WASHINGTON — The Food and Drug Administration launched a website Tuesday where patients and health care professionals can find safety information about recently approved drugs and vaccines. On the Postmarketing Drug Safety Evaluations site, the FDA plans to share what it has learned about the safety of… Continue Reading

FDA plans to speed reviews and visit China

Posted in FDA Regulation

I agree that visits to China should be at the top of the FDA priority list.  I’m not sure about increasing the speed of drug reviews, though, unless that speed increase comes from increased staff.  Asking existing staff to do more in less time is a recipe for another Vioxx disaster. NEW YORK (Reuters) –… Continue Reading

FDA employees will receive training at Duquesne University

Posted in FDA Regulation

These employees are charged with reviewing applications to market new drugs.  Obviously, the more training they get, the better.  (And if you didn’t know, it’s pronounce Dookane.) Duquesne University will have a hand in the training of federal employees charged with reviewing pharmaceuticals, as part of a consortium of schools that won a two-year $652,000… Continue Reading

Drugmakers Seek FDA Seal of Approval for Internet

Posted in FDA Regulation

This sounds like a fantastic idea to me. WASHINGTON, Nov 9 (Reuters) – A drug industry group on Monday urged the U.S. Food and Drug Administration to adopt a universal safety symbol for Internet content containing FDA-approved information about a medicine or medical device. The proposal from the Pharmaceutical Research and Manufacturers of America, which… Continue Reading

FDA Taking Interest In Link Between Gadolinium and Nephrogenic Systemic Fibrosis (NSF)

Posted in FDA Regulation, Misc. Drugs

I think I first learned about the link in early 2008.  Nice to see the FDA taking an interest. WASHINGTON, Nov 17 (Reuters) – Some contrast agents used with magnetic resonance imaging scans appear to carry a higher risk of a potentially fatal skin disease than others, U.S. drug reviewers said in documents released on… Continue Reading

FDA Considering Outsourcing Core Functions

Posted in FDA Regulation

As if that wasn’t bad enough, they’re considering outsourcing them to a group with strong ties to the pharmaceutical industry.  Sounds like a bad idea to mw. WASHINGTON (Dow Jones)–The U.S. Food and Drug Administration is considering outsourcing decisions about the effectiveness of antibiotics, according to Rep. Rosa DeLauro (D., Conn.). "It is very troubling… Continue Reading