FDA calls states’ bluffs on drug importation - STAT News

• California Designated Representative Training - for wholesalers, 3PL. $525 per student. Board approved. Earns a training affidavit suitable for your license application.
• People also buy these California Des Rep training classes for:
       Wholesalers | 3PL | Reverse Distributors

According to the article:

"For decades, critics of the U.S. drug pricing system have advocated importing drugs from Canada as a convenient shortcut to lower prices. The Food and Drug Administration’s recent release of a proposed regulation to create a process for approving state-sponsored importation plans is one step closer to that goal. A closer look shows that it’s actually a false step."

Read the full source article:  FDA calls states’ bluffs on drug importation - STAT News

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

-------------------

California Designated Representative Training - for wholesalers, 3PL. $525 per student. Board approved. Earns a training affidavit suitable for your license application.

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Thrills and Pills: Another Top 5 Scary Pharma Flicks - Pharmaceutical Manufacturing

• FDA: QSR and cGMP Training Courses by SkillsPlus International Inc.

Read the full article:

Thrills and Pills: Another Top 5 Scary Pharma Flicks - Pharmaceutical Manufacturing

"It’s that time of year when watching a movie means snuggling up to a blood-curdling tale that will make you want to hide under the covers. And filmmakers love to tap into the collective fear of Big Pharma, bad medicines, and drug experiments gone horribly awry."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

-----------------

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Accusations highlight special pharmacies - Business Insider

Read the full article: Accusations highlight special pharmacies - Business Insider:

"Whether you believe accounting fraud allegations levied against pharmaceutical-firm Valeant or not, one thing is certain.

The pain isn't over — not for Valeant, not for any company in the pharmaceutical industry.

That's because what's really at the heart of the accusations against Valeant is the use of a new, shadowy segment within the pharmaceutical industry: specialty pharmacies."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Drug Firms Use Tor to Shop for Dark Web Fakes - Bloomberg Business

Read the full article: Big Pharma's Darknet Drug Deal - An Ex-Detective Is Tracking Down Knock-Offs To Counter A Dangerous Trade -  Drug Firms Use Tor to Shop for Dark Web Fakes - Bloomberg Business:

"For the $300 billion pharmaceutical industry, the rapid growth of such marketplaces is a serious threat to profits and reputations. For regular folks who turn to the darknet because they’re uninsured or their coverage won’t pay for expensive medications, the choice can be lethal. Counterfeit drugs bought online have been shown to include everything from gypsum and rat poison to heavy metals and household cleaners."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Healthcare Industry: The Top Target of Cyber Attacks - Pharmaceutical Compliance Monitor

Read the full article: Healthcare Industry: The Top Target of Cyber Attacks - Pharmaceutical Compliance Monitor:

". . . it might come as a surprise that most data breaches occurred within the medical/healthcare category. According to the Identity Theft Resource Center, 600+ breaches have taken place through October 2014—up nearly 26 percent from 2013. Healthcare providers and organizations account for approximately 42 percent of all breaches with 7.4 million personal records exposed this year alone.

Looking at these numbers it’s hard to argue against the vulnerability of any organization, regardless of their stature. Today, with advanced tools at hackers’ disposal, it’s truly not a matter of ‘if’ but ‘when’ a data breach will materialize."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Pharma needs ‘radical change’ says report | Pharmafile

Pharma needs ‘radical change’ says report | Pharmafile:

""Costs are sky-rocketing. Breakthrough innovation is ebbing. Competition is intense and sales growth is flattening," he adds.

It all adds up to investors attributing less value to companies’ pipelines, KPMG contends.

The perception of the pharma 'value chain' needs to change to a new 'value ecosystem' "which puts the patient and the customer at its centre, with other business services wrapped around their needs", KPMG believes."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

inShare

Pharma Cargo Theft Takes New Spike - FiercePharma Mfg

Pharma cargo theft takes new spike - FiercePharma Manufacturing:

"the trend has turned up again. The logistics and security company reported that in 2013, full-truckload pharmaceutical thefts jumped by 50% to 33 from 22, with the average loss up 14.15% to $261,819. Total pharma thefts, including last-mile cargo theft, spiked to 83, with an average loss of $180,346 in 2013. That was up from just 36, with an average loss of $153,697, in 2012. Last-mile thefts usually involve street criminals who rip off pharmacy delivery vans."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Growing Anger Against The Pharmaceutical Industry

• Respected FDA CGMP online training courses sold by SkillsPlus International Inc.

We The People vs. The Pharmaceutical Industry - Forbes:

". . . All this adds up to a giant pushback against the astronomical drug prices that are becoming commonplace. It seems that price tags of $100,000 or above are becoming the norm. Of 12 cancer drugs approved in 2012, 11 cost more than that. As more drugs are offered at that level and their sponsors get away with it, it seems to set a floor that emboldens drug companies to push the envelope. They are badly misjudging the brewing anger. . . ."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Big Pharma Should Use Some Silicon Valley Techniques

I enjoyed reading the article below.  It was interesting and struck a chord for me.

Strategy: Why Big Pharmas Do What They Do -- And How Silicon Valley Might Help Them Think Differently - Forbes:

"The aggressive application of emerging analytic and digital health technologies, while currently viewed as “nice to have” at best, are likely to emerge as table stakes in a world focused on the more precise identification and delineation of value."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

DOJ - Compliance - Ask Yourself These 5 Questions

• FDA GMP QSR cGMP Online Training - trusted GMP online training classes offered by SkillsPlus International Inc.

The article below challenges you to think about your people and compliance in the form of 5 questions.

Five Compliance Questions to Ask Yourself, from the DOJ:

"the US Justice Department (DOJ) – in the name of “protecting consumers where they are most vulnerable,” according to Frimpong – is also placing a “focus on people,” since processes and policies (at least publicly-circulated processes and policies) don’t typically break the law; people do. “We know there are enormous cost pressures, but you can’t sacrifice safety under these pressures,” said Frimpong.

To that end, Frimpong recommended that attendees ask themselves five questions about the group of people they work with, to help identify potential problems before they result in an investigation or worse."

'via Blog this'

You might also be interested in:

Executive Session: What Leadership Needs to Know - an on-site course
Management Session: What Every Manager Needs to Know - an on-site course

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• The Exemptee Institute just launched (skillsplusinfo.blogspot.com)
  

FDA - Pharma Warning Letters and Notice of Violation Letters

• Respected FDA GMP online training courses offered by SkillsPlus International Inc.

Warning Letters and Notice of Violation Letters to Pharmaceutical Companies:

"These letters are supplied by the CDER Freedom of  Information Office (FOI).  This page only covers letters issued by Headquarters and the Office of Prescription Drug Promotion (formerly the Division of Drug Marketing, Advertising, and Communications).  For District Office warning letters, please see the Main FDA FOI Warning Letters Page.

Some of the letters have been redacted or edited to remove confidential information.  Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. "

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Exemptee Institute
The Designated Representative Institute
The Health, Drug, Prescription, and GMP Supersite Gift Store 

2012 - Top Pharma Acquisitions (AZN, BMY, GSK)

The Top Pharma Acquisitions of 2012 (AZN, BMY, GSK):

"Pharma largely backed off mergers and acquisitions this year, but there were still a couple of deals earning attention. Bristol-Myers Squibb (NYSE: BMY  ) and AstraZeneca (NYSE: AZN  ) made a significant diabetes play. GlaxoSmithKline (NYSE: GSK  ) absorbed a pipeline partner with a small stable of drugs. The deals helped these big pharma players diversify their portfolio and offset revenues lost to patent expirations."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Exemptee Institute
The Designated Representative Institute

Bad Pharma - Book Review

• FDA CGMP Online Training. Current Good Manufacturing Practice Training: A New Generation Series - CGMP Online Courses | Provided by SkillsPlus International Inc.

No doubt this will be a provocative read.  Follow the link to a comprehensive review of the book.

Science-Based Medicine » Bad Pharma: A Manifesto to Fix the Pharmaceutical Industry:

"Closing thoughts
This is a book with important messages for patients, health care professionals, governments, and the pharmaceutical industry. It may anger, and even infuriate you. It should. Yet Goldacre sketches out a path for reform – one in which transparency is the rule, not the exception, and one in which the pharmaceutical industry can engage with the health care system in ways that will help it do what we all want it to do – bring innovative new medications to market that improve the health and welfare of patients. This change, however, will only come when we demand better – better from pharmaceutical companies, better from regulators, and better from our fellow health professionals. Ultimately, we’ll have the industry we deserve – if we’re not willing to demand better, we’re never going to see any improvements. This book is your call to action."

'via Blog this'

Order the book through Amazon.com:
Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (Kindle Edition)

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Pharma Forecast 2020: Cold Comfort

This summary article calls out a sobering list of things that are likely to put a damper on the pharma industry.

Pharma Forecast 2020: Cold Comfort:

"Despite such a bleak forecast, the report predicts “a golden era of renewed productivity and prosperity.” It recommends that above all, corporations should focus on collaboration with other players and academia, offer real-time outcomes data to establish value of medicines, reinvigorate corporate ethics standards, and use new procedures and technologies to revolutionize R&D. The message can be further condensed to something along the lines of: “Trim the fat and get with the times.”"

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA issues first social media rules for drug companies

amednews: FDA issues first social media rules for drug companies : Jan. 25, 2012 ... American Medical News:

"The Food and Drug Administration is giving pharmaceutical companies some rules for how they interact with consumers on social media. But the companies say they need a lot more clarification from the FDA before they're comfortable getting back online again. 

The draft guidance encourages all responses to unsolicited requests for information, which could include requests from physicians for information on off-label uses for certain drugs, to be made in a nonpublic format."

'via Blog this'

Read this draft guidance:
FDA - Guidance for Industry - Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (PDF)

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP and QSR Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Related articles

• Should Mobile Medical Apps Require FDA Approval? (drughealth.blogspot.com)

FDA Awards University Consortium To Improve Drug Manufacturing

Drug shortages: University of Maryland, other universities work to improve drug manufacturing process - baltimoresun.com:   'via Blog this'

The Food and Drug Administration (FDA) has given "a $35 million grant to" the National Institute for Pharmaceutical Technology and Education, a group of 11 universities, "to make the nation's drugs safer and less costly, and even produce more jobs, by improving the science of manufacturing."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:

Our most popular course

Put fun back into GMP training!

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Securing Pharma Supply Chain - Senate HELP Committee Hearing - Videos

• For people who need FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
  

Updated November 7, 2021

A broken link was removed.

---  the original post follows below  ---

The Senate Health, Education, Labor and Pensions (HELP) Committee is examining the globalization of the pharmaceutical drug market and supply chain. Senators are seeking solutions for how to improve the FDA's inspection of foreign drugmakers and secure the drug supply chain - without adding too much to the agency's bottom line.

Here's a brief video snippet of the entire hearing. Senator Mike Enzi (R-Wyo.), Ranking Member on the Senate Health, Education, Labor and Pensions (HELP) Committee:

You can watch the entire hearing, Senate Committee on Health, Education, Labor and Pensions - Full Committee Hearing - Securing the Pharmaceutical Supply Chain - September 14, 2011 (video).  If you follow this link, you can access the text of the testimony given by each witness.  If you want a slightly larger video image, you can try watching:  C-SPAN - Committee Examines Foreign-made Pharmaceuticals - September 14, 2011 (video). 

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Make GMP Training Effective - free tips

• FDA GMP QSR cGMP Online Training - popular GMP online training classes offered by SkillsPlus International Inc.

Updated November 1, 2021

The original link broke.

You might also be interested in recommended FDA CGMP online training courses and programs by SkillsPlus International Inc.

---  the original post follows below  ---

More food for your GMP training thoughts. Some free training tips.

Why GMP Training Does Seem To Work - SkillsPlus International Inc. Training Tips (pdf):  'via Blog this'

In a nutshell:

• You must address poorly designed or delivered training.
• It is essential that you align what's preached with what's practiced.
• The organization must support and encourage GMP compliance in everything that they do.

For more information:

SkillsPlus International Inc. - Compliance training experts. GMP, QSR, Designated Representative and Exemptees.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

Courses, classes, workshops, and seminars - FDA QSR GMP cGMP training

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors

Related articles

• GMP & QSR Trainers Must Be More Than Just Subject Matter Experts (skillsplusinfo.blogspot.com)
• How To Train Other GMP-QSR Trainers (skillsplusinfo.blogspot.com)
• FL Certified Designated Representative - Use The Most Current CIB (skillsplusinfo.blogspot.com)
• CA Pharmacy Designated Representative - Online CBT Training (skillsplusinfo.blogspot.com)

Annual FDA Inspections Summit

• The best and recommended choice for FDA GMP QSR cGMP Online Training: FDA cGMP QSR GMP Online Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training | Recommended | Respected | Popular | The best choice for FDA CGMP online training courses and programs.

Updated June 5, 2025

The original link broke.

You might also be interested in the Annual FDA Inspections Summit:

https://wcg.swoogo.com/fda-inspections-vsummit

- -  original post follows below  - -

Sixth Annual FDA Inspections Summit:  'via Blog this'

This caught my eye. I'm sharing it because I know that many of you have an interest in FDA inspections.  The Sixth Annual FDA Inspections Summit is scheduled for Tuesday, Oct. 4 - Thursday, Oct. 6, 2011, in Bethesda, MD.

With a quick Google search, the other large event seminar offering an FDA Inspection focus, was this seminar held earlier in the year:

ISPE - The FDA inspection enforcement trends seminar, titled, “Pharmaceutical Inspections and Compliance: Current FDA Enforcement Trends,”

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog

Related articles

• FL Certified Designated Representative - Use The Most Current CIB (skillsplusinfo.blogspot.com)

Drug Poisoning Increase In Children

Pharmaceutical drug poisonings rise in children - latimes.com:  'via Blog this'

The LA Times article gives a nice highlight and summary of the much longer research article published in the Journal of Pediatrics, The Growing Impact of Pediatric Pharmaceutical Poisoning.

To give you an idea of what they found,  I'm sharing just a portion of their conclusion:

"We conclude that the problem of pediatric medication poisoning is getting worse, not better. Past preventive efforts have proved to be inadequate. More children are exposed, more are seen in an ED, more are admitted, and more are injured each year."

Not surprisingly, there are mentions that medical bottles and packages may need to be redesigned to limit how fast a child can consume medication, and that drugs should be stored in locked cabinets, and unused medications need to removed from the home.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - GMP Compliance Training Experts
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store