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Are Fears About FDA’s Generic Drug Oversight Justified?

There have been so many reports of problems with FDA's oversight of generic drugs, we have lost count. A new one from Bloomberg is the most shocking yet!

A year-long investigation by Bloomberg News has revealed substantial concerns about the quality of generic drugs. The four-part series is mind-boggling in its revelations. Here are the first three articles: Part 1: “America’s Love Affair With Cheap Drugs Has a Hidden Cost: Data, documents and interviews show how a focus on cutting prices has come with risks to consumer health.”  Part 2: “How a Tainted Heart Drug Made in China Slipped Past the FDA: Lag in U.S. recall highlights strains in global pharmaceutical supply chain.”  Part 3: “Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency: The FDA confronts creative improvisation in the world’s largest generic-drug exporter.”  We encourage you to read the articles about FDA’s generic drug oversight. We suspect that you will be as dismayed as we are.

How Worrisome is FDA’s Generic Drug Oversight?

According to the report, 90% of the medicines Americans swallow are now generic. The FDA does little, if any, testing itself, relying largely upon data from the manufacturers. This means that they trust generic drug companies to submit accurate data.

Can We Trust the Data?

Investigative journalist, Katherine Eban, wrote an article for Fortune Magazine titled Dirty Medicine” (May 15, 2013).  In it she notes that the Indian generic firm Ranbaxy paid $500 million in fines, forfeitures and penalties and 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.”

Perhaps more damaging was a statement by a past head of the Office of Generic Drugs for the FDA. Gary Buehler led this program at the FDA for a decade. We ourselves had many interactions with him about problems we uncovered with generic drugs. He reportedly stated that the information the agency uses to approve generic drugs comes from the companies.

“‘We depend on that information to be truthful.’ The approval system ‘requires the ethical behavior of the applicant,’ he said. Otherwise, “the whole house of cards will fall down.’” [emphasis ours]

Generic Drug Oversight?

The Bloomberg articles document a number of egregious errors by generic drug manufacturers. Most people assume that they all occur abroad in countries like China, India or Taiwan. But here is a disconcerting story about Mylan, the second largest generic drug manufacturer. Inspectors descended upon a plant in Morgantown, West Virginia. Anna Edney of Bloomberg News notes that:

“A tipster raised concerns there might be unscrupulous activity at the factory where the generic giant makes some of its top-selling drugs.”

An FDA executive once shared with us the scary idea that the FDA has to rely on whistleblowers or tipsters to alert it to fraud. The only problem is that whistleblowers often have their lives turned upside down. Revealing secrets about bogus clinical trials or unscrupulous behavior can terminate a career in the pharmaceutical industry overnight. It’s not surprising that there are very few Pharma employees who are willing to blow the whistle on their employers.

In the case of the Mylan inspection, the Bloomberg report states:

“The inspectors suspected Mylan laboratory staff had recorded passing scores on drugs that originally fell short of U.S. quality standards.”

Anna Edney writes:

“The inspectors also found bins full of shredded documents, including quality-control records, in parts of the factory where every piece of paper is supposed to be saved. The list of alleged infractions became so long that a fourth inspector was added. A warning letter, the FDA’s strongest rebuke, was drafted.”

You might think this kind of FDA generic drug oversight would have led to strong reprimands. Instead, the FDA “apparently decided to take it easy on Mylan…” No warning letter was sent. The FDA counted on Mylan to fix the “data integrity” problem without an official spanking.

Problems with Generic Drug Oversight in China?

Bloomberg reports that one out of every 10 generic drugs approved by the FDA for the U.S. market now comes from China. That does not count medications made in India that use Chinese chemicals to formulate pills there.

Perhaps you have heard that major heart and blood pressure medicines called “sartans” (losartan, valsartan and irbesartan) have been recalled because of contamination. An FDA inspection of the Zheijiang Huahai Pharmaceutical Co. in Linhai, China back in May of 2017 revealed there might be significant problems at the plant.

The inspector recommended a strong warning letter be sent to the company that might have affected production. FDA managers back at headquarters in the U.S. apparently “overruled the inspector,” according to Bloomberg.

The Sartan Recalls Begin

On July 5, 2018, over a year later, the European Medicines Agency reported problems with Chinese-made valsartan from the Zhejiang HuaHai Pharmaceutical company in Linhai, China. Here is our first People’s Pharmacy Health Alert from a week later.

Valsartan Blood Pressure Pills Recalled over Cancer Concerns

The Never-Ending Recall:

This scandal just keeps getting worse. So many lots of valsartan (and valsartan plus HCTZ or valsartan plus amlodipine) have been recalled that we have lost count. Aurobindo recently recalled 80 lots amounting to more than 20,000 bottles with goodness knows how many pills in each bottle.

Bloomberg isn’t the only organization that has reported on the problem of FDA oversight. We have written about A Kaiser Health News expose just two weeks ago. Here is a link.

Can You Trust the FDA’s Generic Drug Oversight?

That is a question we leave up to you and your health professional. Bloomberg cites the results from an online-pharmacy startup called Valisure.  The company actually tests the medications that it dispenses.

According to Bloomberg:

“Since opening last year, it has screened about 100 drugs and found that more than 10 percent didn’t have the proper amount of active ingredient or didn’t dissolve as they should.”

We talked to the CEO, David Light. He assured us that Valisure’s online pharmacy tests every batch of medication it sells. We know of no other pharmacy in the U.S. that actually tests pills before selling them. Even the FDA rarely, if ever, tests generic drugs for quality or dissolution.

The People’s Pharmacy Perspective:

We were surprised to read tweets from the FDA commissioner that attempted to “counteract” the reporting from Bloomberg. Dr. Gottlieb wrote:

Scott Gottlieb, M.D.‏Verified account @SGottliebFDA 7 hours ago

“Americans should be assured generic drugs are just as safe and effective as brand counterparts and often made in same facilities. Selectively construed facts, to paint different portrait, can put patient care at risk. FDA is confident in the overall safety and quality of generics”

This comes after one of the largest recalls in FDA history involving contamination of losartan, irbesartan and valsartan with a probable carcinogen. We have asked the agency for a count of the number of pills that have been recalled but we do not expect an answer. Here is a link to the FDA’s website if you want to see which lots have been recalled. It is overwhelming.

There are now shortages of valsartan. We would not be surprised if other shortages also crop up. This is all because generic manufacturers have sold contaminated medicines.

Over the years we have written extensively about how we discovered that FDA’s oversight of generic drugs leaves a lot to be desired. You can read about that process in our book, Top Screwups. We don’t just leave you without an action plan. We offer ways to overcome the generic drug oversight problem. We also think that Valisure represents a whole new way for patients to regain trust in a pharmacy that dispenses generic drugs.

Share your thoughts about the FDA’s oversight of generic drugs in the comment section below.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.”.
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