October 2019

Generic drugs

US reliance on China for generic drugs is a security threat

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

This recall will affect patients suffering from various conditions of excess stomach acid. But it’s the security of the generic drug supply as a whole that should give every American heartburn.

Congress is currently focused on a legislative effort to reduce out-of-pocket spending on brand name prescription drugs. It is a commendable effort. Yet the other pressing problem with prescription drugs should not be overlooked: the safety risks posed by many generic drugs, which make up roughly 90% drugs that Americans take.

Ranitidine is just the latest in a string of generic prescription drug safety contaminations over the past few years. Last year, the FDA announced that the same carcinogen had contaminated popular blood pressure medication valsartan, prompting a massive recall that affected Tens of millions of sick.

The biggest prescription drug crisis in recent years was the 2008 contamination of heparin, a widely used blood thinner. The FDA estimates that 149 Americans died and several hundred others were seriously injured.

What is responsible for the repeated breaches of drug safety? The relocation of US drug supply to China and, to a lesser extent, to India over the past two decades.

Lax safety standards and FDA oversight at factories in both countries have allowed these drugs — and likely countless others we don’t know about — to become contaminated and put patients at risk. China and India now manufacture about 80% of drugs consumed in the United States This figure underestimates the dominance of China because many active ingredients of drugs manufactured in India come from China. The United States no longer even manufactures life-saving drugs like antibiotics, with the last penicillin plant closing in 2004.

In 2017, FDA inspectors investigation a factory of the Chinese company Huahai Pharmaceuticals, which manufactured contaminated valsartan, and found rust, deteriorated equipment, ignored consumer complaints, tested for anomalies and potential contamination. Of them other Chinese herbs were cited by the FDA last year for inadequate cleaning and maintenance procedures, unlocked and improper registration forms, and inadequate testing, among other violations.

FDA inspectors are unable or unwilling to provide proper oversight of Chinese manufacturing. Unlike the rigorous testing required for the approval of new prescription drugs, the FDA does not requires that generic drug makers prove that patients will absorb the drugs at the same rate as the brand name drugs they copy.

A 2016 Government Accountability Office report finds that some Chinese drug factories are never investigated, while others are rarely scrutinized. At the time of the report, the FDA only has 29 employees to inspect more than 3,000 foreign manufacturing facilities. And, the number of FDA investigators overseas fall 25% between 2016 and 2018, with two of the three control offices in China closing during the last years. According to a Bloomberg analysis, the FDA checks the safety of less than 1% of foreign-made drugs before allowing them to enter the country. And manufacturers are usually notified before inspections.

Given the growing trade war and animosity between the two countries, the complete dependence on China for basic drugs from the United States also poses a threat to national security. China’s dominance in drug manufacturing gives it a nuclear option in the ongoing trade war. Millions of Americans could die without access to lifesaving drugs if China decides to militarize its drug manufacturing.

To ensure the safety of generic drugs and to protect against this threat to national security, the United States must produce its most life-saving drugs, such as antibiotics, insulin, and anesthesia, at home. In their 2018 book “China RX,” Authors Rosemary Goodwin and Janardan Prasad Singh outline 10 steps to achieve this goal. These include viewing drugs as a strategic asset, offering incentives to bring manufacturing home, and increasing FDA drug testing.

Lawmakers plan to hold hearings soon on China’s dominance in the manufacture of prescription drugs. These hearings should recommend that any future comprehensive prescription drug legislation include an element of relocation. If the status quo prevails, the country will continue to experience dangerous and widespread drug contamination – at best.

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