By Vickie Yates Brown Glisson
May 31, 2019 at 5:00 am ET
Pharmaceutical drugs have become a vital part of modern medicine. From daily maintenance medications taken for chronic conditions to the life-saving specialty treatments administered in hospitals, it is hard to imagine a world where safe and effective drugs are not widely available.
Yet a flurry of recent news stories has called into question the purity and efficacy of some drugs, particularly those manufactured in overseas facilities. A recent NBC News report sounded the alarm about valsartan, a drug widely taken for high blood pressure that was found to contain a carcinogen. In 2018, an Ohio man went into heart failure after his torsemide prescription was sourced from a different manufacturer.
The common thread in both these cases? Both problem pharmaceuticals were generic drugs.
These are not isolated incidents but true stories that can happen to anyone. My husband, a medical oncologist/hematologist, was recently treating a patient with stage-4 adenocarcinoma of the lung. While receiving chemotherapy, the patient suffered a severe anaphylactic reaction that required intubation and mechanical ventilation in the intensive care unit of the hospital.
The reaction occurred moments after receiving a generic drug that was part of her chemotherapy. Three additional patients had a reaction to the same drug on the same day at the same oncology clinic, and while their reactions were not as severe, they underscore what can happen when drugs of inferior quality are used.
Everything was done right. The treating physicians checked for nursing and pre-medication compliance and validated that proper protocols had been followed.
The physicians wanted to know whether this was a typical reaction to the drug or whether it was a bad batch from one of the generic manufacturers. If the problem had occurred with a drug still on patent, the provider would usually contact the company. A physician’s recourse when problems occur with a generic drug is much more limited.
Stories like this are unfolding all over the country, and while they are not making the news, the risks to Americans are very real. In the United States, 9 out of 10 prescriptions are filled with a generic drug. The number of generic drugs approved by the Food and Drug Administration has increased by 94 percent since 2014 and does not appear to be abating.
Issues with quality are on the rise because large numbers of generic drug companies have chosen to locate their production facilities in countries with cheaper labor and manufacturing costs like China and India. Although the FDA conducts 3,500 inspections of manufacturing plants a year, oversight of facilities abroad can be difficult and challenging. This has been exacerbated by funding cuts that caused the number of surveillance inspections done globally to drop 11 percent in fiscal year 2018.
As a result, the FDA inspected only one in five registered human drug manufacturing facilities located abroad last year. The FDA typically relies on the drug manufacturers to identify and report problems.
Physicians have become increasingly alarmed about the integrity of data provided from drug manufacturers in foreign countries such as India and China. Warning letters from the FDA to drug manufacturing plants in these countries have increased significantly with both countries receiving 39 of the 61 notices sent by the Office of Manufacturing Quality in the FDA’s Center for Drug Evaluation and Research in 2017. But when drug companies operate in countries that do not recognize our country’s laws, there is little if anything that can be done to enforce compliance.
Without a legal system accessible to provide protection, these drug manufacturers are essentially able to circumvent existing protections created to preserve the integrity and quality of the drugs consumed by the American public. Examples range from instances of cover-ups, fraud and deliberate misrepresentation to times when facilities in China have outright refused to allow FDA inspectors to enter and inspect their operations.
As generic drugs continue to constitute a larger share of the pharmaceutical markets, the number of facilities locating in countries such as China and India will continue to grow. Foreign obstruction and a strained inspection system will continue to jeopardize the safety of drugs made overseas.
To date, Congress has held several hearings looking into the issue of drug quality control. This is a step in the right direction, but more significant efforts must be taken quickly. At the very least, greater transparency and access to drug data must be made available by the FDA to providers so they can monitor drug safety information.
The health of the citizens of our country is as much at stake as the patient receiving the tainted chemotherapy drugs in my husband’s oncology clinic. Under the current system, it could happen to any of us.
Vickie Yates Brown Glisson is the former Kentucky secretary of the Cabinet for Health and Family Services and a nationally recognized health lawyer.
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