FDA calls states’ bluffs on drug importation - STAT News

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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

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‘Dump it down the drain’: How contaminants from prescription-drug factories pollute waterways - STAT

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Read the full article:  ‘Dump it down the drain’: How contaminants from prescription-drug factories pollute waterways - STAT

According to the article:

"Over the past decade, cocktails of drugs from opioids to antidepressants have been showing up in rivers all over the U.S. Studies have detected these chemicals in the bodies of fish and aquatic insects, altering behaviors that are key to survival. Now, an investigation by STAT and Type Investigations identifies for the first time major drug companies that are likely dumping substantial quantities of drugs from their manufacturing facilities into rivers and streams."

Six Ways Amazon Could Invade the Pharmacy Business - Bloomberg

Read all the six ways:  Six Ways Amazon Could Invade the Pharmacy Business - Bloomberg:

"Amazon already owns wholesale distribution licenses in at least 13 states and could build its own pharmacy business from scratch, restructuring the drug supply chain in the process. For now, these wholesale licenses may be part of Amazon’s business-to-business sales effort, which would focus on hospitals, doctors’ offices and dentists. "

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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."

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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."

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FDA > Press Announcements > FDA targets illegal online pharmacies in globally coordinated action

Ritalin (Photo credit: Wikipedia)

Press Announcements > FDA targets illegal online pharmacies in globally coordinated action - FDA:

"The FDA and the CBP inspected packages at the mail facilities in Los Angeles, New York and Chicago, and detained or seized 583 packages. Preliminary findings show that certain drug products from abroad, such as insulin, estrogen, bimatoprost, human chorionic gonadotropin, tramadol, tadalafil and sildenafil citrate were on their way to U.S. consumers. The FDA also notified Internet service providers, domain name registrars and related organizations that 1,975 websites were selling products in violation of U.S. law."

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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."

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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."

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Dirty Medicine - A Fortune Feature - A Must Read!

This is a must-read . . .

Dirty medicine - Fortune Features:

"On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties -- the most ever levied against a generic-drug company."


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Growing Anger Against The Pharmaceutical Industry

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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. . . ."

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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."

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FDA Focusing On Food & Drug Manufacturing GMP Compliance

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Updated December 9, 2021

Links in the original post broke.

You might also like:

Current Good Manufacturing Practice (CGMP) Regulations - FDA.gov

Compliance & Enforcement (Food) - FDA.gov

---  the original post follows below  ---

FDA is focusing on cGMP compliance by food and drug manufacturers.

FDA investigative chief eyes manufacturing practices:

"John Roth, director of the FDA's Office of Criminal Investigations, said officials are seeking to ensure that companies are appropriately balancing their profit motives with the need to manufacture food and drugs responsibly.

The meningitis outbreak and other recent cases have spurred the agency to take a closer look at this balance, Roth told lawyers at an American Bar Association-sponsored conference in Las Vegas focused on white-collar crime.

"We wonder exactly if this is a systemic problem, if it requires a broader response by the FDA or is it an anomaly," Roth said in a panel discussion Friday. "We're going to be taking a look at that and hopefully we'll launch in a thoughtful way.""

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You might also be interested in:
On the FDA website - FD&C Act Chapter III: Prohibited Acts and Penalties

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CMS Issues Sunshine Rule - Applies to Drug and Device Manufacturers

CMS Issues Sunshine Rule:

"The rule, a provision of the Affordable Care Act known as the Physician Payments Sunshine Act, "finalizes the provisions that require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children's Health Insurance Program to report payments or other transfers of value they make to physicians and teaching hospitals to CMS," the statement explained. "CMS will post that data to a public website. The final rule also requires manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.""

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Physician Payments Sunshine Act (the "rule") - the Federal Register pre-publication version
Physician Payments Sunshine Act (the "rule") - the official Federal Register published version

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Too Little Reward For Quality - Drives Generic Injectable Shortages

Clinical Pharmacology & Therapeutics - Economic and Technological Drivers of Generic Sterile Injectable Drug Shortages:

"Over the past few years, an increasing number of critically needed medicines have been in short supply. Using economic theory to frame the drug-shortage problem, this paper explores why and how manufacturing-quality problems could combine with other economic and technological factors to result in shortages of generic sterile injectable drugs. The fundamental problem we identify is the inability of the market to observe and reward quality. This lack of reward for quality can reinforce price competition and encourage manufacturers to keep costs down by minimizing quality investments."

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FDA - Pharma Warning Letters and Notice of Violation Letters

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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. "

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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."

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More fake drugs now using active ingredients

SecuringIndustry.com - Many more fake drugs now using real APIs, US official says:

"The US Department of Commerce reports that more and more counterfeit pharmaceuticals are using real APIs to trick patients.

Globalisation of the active pharmaceutical ingredient (API) supply chain means raw materials are more readily available in countries where counterfeit manufacturing takes place.

The trend has helped counterfeiters change the composition of their products, Security Management reports.

"Twenty years ago most counterfeit medicines did not contain any medicinal ingredients. They had ground up dry wall, sawdust, anything to make the product look real," said Jeffrey Gren, director, Office of Health and Consumer Goods at the US Department of Commerce, said."

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Bad Pharma - Book Review

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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."

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

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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.”"

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Critical Shortage of Children's Leukemia Drug

It's very concerning and a shame that we even have this situation.

Critical Shortage of Children's Leukemia Drug - ABC News:

"Medication used to treat the most common form of childhood leukemia is in short supply, adding to the largest nationwide shortage of critical lifesaving hospital medications in nearly a decade.

All five pharmaceutical companies that make the injection drug methotrexate, which treats acute lymphoblastic leukemia by slowing the growth of cancer cells, have either slowed and stopped manufacturing of the drug, according to the U.S. Food and Drug Administration. The companies have cited high demand or manufacturing delays as reasons for the shortage.

If the shortage continues, physicians and pharmacists fear thousands of children will be left without lifesaving treatment."

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