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Sometimes you need an in-depth knowledge and understanding of medications for your case. In such situations, Strom and Associates can be your friend. Contact us for complete expert witness services including consulting, evidence review, reports, and testimony.

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Acing Pharmacy Operations Reviews

Running a pharmacy business is hard. You need a helping hand to follow all the directives of the regulators. Strom and Associates can help. Contact us to have a top-to-bottom assessment of your operations.

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Opioid/Controlled Substance Related Compliance

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Long-Term Care Assisted Living Battles

Long-Term Care/Assisted Living Battles

Has a lawsuit been filed against you for allegedly negligent care in your long-term care or Assisted Living facility? Are you sure your counsel has hired the right experts? Well, that’s what Strom and Associates are here for. Contact Us to know more.

The Other U.S. Prescription Drug Problem

China’s dominance in the production of generic drugs is part of a greater medical security threat to the United States.

By Holly Strom and Kenneth SchellOct. 1, 2019, at 4:32 p.m.
U.S. News & World Report
China and India now manufacture about 80% of the drugs consumed in the U.S.

LAST WEEK, DRUGMAKER Novartis issued a recall of generic versions of the popular heartburn medication Zantac. The Food and Drug Administration recently announced that the drug’s active ingredient, ranitidine, had been contaminated with a carcinogen known as NDMA. On Monday, CVS pulled Zantac and its generics from its shelves; Walgreens had already stopped selling the drug earlier.

This recall will impact patients suffering from a variety of excess stomach acid conditions. But it’s the safety of the generic drug supply as a whole that should give all Americans heartburn.

Congress is currently focusing on a legislative effort to reduce the out-of-pocket costs of brand name prescription drugs. This is a worthy effort. Yet it shouldn’t overlook the other pressing prescription drug problem: the safety risks posed by many generic drugs, which make up roughly 90% of the drugs Americans take.

Ranitidine is just the latest in a string of generic prescription drug safety contaminations in recent years. Last year, the FDA announced that the same carcinogen contaminated the popular blood-pressure medication valsartan, spurring a massive recall that affected tens of millions of patients.

The biggest prescription drug crisis of recent years was the 2008 contamination of heparin, a widely used blood thinner. The FDA estimates that 149 Americans died and many hundreds more were seriously injured as a result.

What’s responsible for the repeated drug safety lapses? The offshoring of the American drug supply to China and, to a lesser extent, India during the past couple of decades.

Lax safety standards and FDA oversight at plants in those two countries have allowed these drugs – and likely countless more we don’t know about – to become contaminated and endanger patients. China and India now manufacture about 80% of the drugs consumed in the U.S. This figure understates China’s dominance because many of the active ingredients in the Indian manufactured drugs come from China. The U.S. doesn’t even manufacture vital drugs like antibiotics anymore, with the last penicillin factory closing in 2004.

In 2017, FDA inspectors investigated a plant at China’s Huahai Pharmaceuticals, which manufactured contaminated valsartan, and found rust, deteriorating equipment, ignored consumer complaints, testing anomalies and potential contamination. Two other Chinese plants were cited by the FDA last year for inadequate cleaning and maintenance procedures, unlocked and improper recording formulas, and inadequate testing, among other violations.

FDA inspectors are unable or unwilling to provide appropriate oversight of Chinese manufacturing. In contrast to the robust testing required for approval for new prescription drugs, the FDA only requires that generic manufacturers prove that patients will absorb drugs at the same rate as the brand-name medications they copy.

A 2016 Government Accountability Office report finds that some Chinese drug manufacturing plants are never investigated, while others are looked at infrequently. At the time of the report, the FDA only has 29 staff to inspect more than 3,000 foreign manufacturing facilities. And, the number of FDA investigators abroad dropped by 25% between 2016 and 2018, with two out of the three inspection offices in China closing in recent years. According to a Bloomberg analysis, the FDA checks less than 1% of drugs manufactured abroad for safety before allowing them into the country. And manufacturers are generally warned before inspections occur.

Given the growing trade war and animosity between the two countries, the utter dependence on China for the U.S.’s basic medicines also poses a national security threat. China’s drug manufacturing dominance gives it a nuclear option in the ongoing trade war. Millions of Americans could die without access to lifesaving medications if China decides to weaponize its drug-making.

In order to ensure generic drug safety and protect against this national security threat, the U.S. must produce its most vital medications, such as antibiotics, insulin, and anesthesia, at home. In their 2018 book “China RX,” authors Rosemary Goodwin and Janardan Prasad Singh lay out 10 steps to achieve this goal. These include deeming medicines a strategic asset, providing incentives to bring manufacturing home, and increasing FDA testing of medications.

Lawmakers plan to hold hearings soon about China’s dominance in prescription drug manufacturing. These hearings should recommend that any forthcoming comprehensive prescription drug legislation include a reshoring element. If the status quo prevails, the country will continue experiencing dangerous and widespread drug contaminations – at best.

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