Pharmaceutical drug supply chain a giant mess and threatens millions of lives

(NaturalHealth365)  Are your pharmaceutical drugs safe?  An astonishing 88 percent of all drug prescriptions in the United States are now dispensed as generic medications – a move that is, for the most part, generally accepted by many American consumers.

For over 25 years, the U.S. Food and Drug Administration (FDA) has been assuring the public that cheaper generic drugs are identical in every way to brand name medications.

But, in light of new revelations about scandals and recalls concerning drugs manufactured by overseas companies – it is only logical to ask: are generic drugs indeed equivalent?

The vast majority of medications used in America are produced abroad, with insufficient oversight

According to pharmacologist Joe Graedon of The People’s Pharmacy, the emphasis on making drugs cheaper – a movement driven by Congress, insurance companies and private and non-profit hospitals – is accompanied by a lack of concern about the safety and quality of generic medication.

This is a relatively recent development, says Graedon. He notes that for over 25 years, he was secure in the belief that the FDA was “totally on top of both the approval and monitoring of generic drugs.”

But, Graedon states, this was a time during which the drugs were manufactured in America. Now, nearly 40 percent of all drugs sold in the US are made in foreign countries, where Graedon calls the FDA oversight “abysmal.”

And here’s an even more eye-opening statistic: about 80 percent of the active pharmaceutical ingredients used in drugs made in the USA are in fact produced overseas – in countries such as Brazil, China, India, Mexico, Thailand and Turkey.

The FDA admits that there are 526 drug-manufacturing plants in India that make products for the US market, with only 10 investigators assigned to the entire country – a woefully inadequate staff. China, also a major manufacturer of American drugs, has 517 factories, covered by only 13 investigators.

Pharmaceutical scandal: Criminal deceit, including bribery, leads to a flurry of warnings and reprimands

Over the past five years, the FDA has banned products from 44 different drug-producing facilities in India. And, in the past three years alone, the FDA has issued reprimands and recalls to Indian companies for an appalling list of errors, oversights and outright lies.

For example, in 2015 the FDA reprimanded the Indian drug manufacturer Wockhardt for hiding undesirable test results and deleting data. The company had formerly been forced to recall hundreds of millions of tablets and capsules – including common blood pressure medications such as lisinopril, antibiotics such as azithromycin and sleeping pills such as zolpidem.

The India-based Dr. Reddy’s Laboratories also ran into trouble – and recalls – for their formulation of Depakote, an epilepsy medication in which their generic copy was too potent.  On the other hand, one of their heart medicines, a combination of two drugs known as Caduet, was found to be not potent enough. Yet another drug made by Dr. Reddy’s – a beta blocker known as metoprolol succinate – was recalled because it did not dissolve properly.

To report a problem with a drug, visit: FDA.gov/MedWatch

But, wait, there are more scandals being ignored by the mainstream media

The World Health Organization discovered problems at GVK Biosciences – which was found to have falsified data on over 7000 different generic drugs.

In March 2016, Novartis paid $25 million to the Securities Exchange Commission due to two China-based Novartis subsidiaries bribing Chinese doctors to prescribe their drugs.

But, one of the biggest scandals may have involved Ranbaxy Laboratories. In 2013, the company was ordered to pay U.S. authorities $500 million in penalties after pleading guilty to felony charges for falsifying data.

The number of FDA warning letters to Indian drug companies has skyrocketed

According to the food and drug law firms Dechert LLP and Hyman, Phelps and McNamara PC, the current enforcement focus is expected to remain on pharmaceutical manufacturing plants outside the United States.

And advocates say it is about time.

In fact, 25 warning letters were sent in 2016 – and only two of them involved facilities inside the United States.  In addition, 14 letters were issued for facilities in India – including Aurobindo, IPCA, Dr. Reddy’s Laboratories and Sun Pharmaceutical Industries – and three were issued based on inspections in mainland China.

There were 16 warning letters that outline violations of data integrity – or inadequate systems to protect data.  If the warning letters aren’t heeded, possible consequences could include product recalls, seizures, injunctions, withdrawal of drug approvals and prosecution.

Consumers must request transparency to ensure safety

As if the fraud and corruption weren’t infuriating enough, Graedon reports that the FDA is not always “forthcoming” about problems with generic drugs. The agency often redacts critical information from official forms – even vital information such as the names of the drugs involved and the reason for their recall.

Graedon maintains that every generic drug approved by the FDA should have its bioequivalence curves and data made available to the public. In addition, the country of origin should be clearly listed on the label.

To request this, you can e-mail the FDA’s Director of the Office of Generic Drugs, Kathleen Uhl, M.D., at [email protected]. {Be polite)  As with the link in the middle of this article, you can also report problems with a generic medication.

Does there have to be a catastrophic drug manufacturing error before pharmaceutical companies begin to “clean up their act” and take responsibility for themselves? The lack of oversight and the unbridled falsification and fraud of foreign drug companies must be resolved.

References:

https://www.dechert.com/files/Uploads/Documents/Dechert%20Webinar_06.22.16_International%20Pharmaceutical%20Supply%20Chain%20Imperiled.pdf