Opinion

The Generics Are Secretly Tainting Patient Care

The struggle for affordable health care is felt far and wide across the nation. As Americans search for prescription solutions to both chronic and acute illnesses, much of their trust lies in the guidance of their doctor.

Many of the drugs prescribed are then replaced with generic counterparts to achieve better pricing and accessibility for patients; however, these generics can come from foreign entities with questionable manufacturing practices and dishonest quality. It’s imperative that legislators weed out these bad actors to preserve innovation for life-saving treatments, so patients can receive proper and affordable care without worrying that their medications will do more harm than good.

Innovative and accessible treatments are critical for aging Americans. West Virginia alone is home to about 350,000 people age 65 or older, a group that is particularly vulnerable to chronic diseases as it continues to age.

Cancer, heart disease and stroke account for the majority of deaths for Americans in this age group. But if pharmaceutical companies continue to invest in their research and development sectors, the startling number of chronic disease-related deaths can turn into manageable illnesses.

According to an analysis by the Partnership to Fight Chronic Disease, the total cost of chronic diseases in West Virginia from 2016 to 2030 will be $265 billion. However, with new treatment breakthroughs, the state could save $1.6 billion a year and 149,000 lives.

This level of life-saving innovation cannot be reached with the number of foreign generic bad actors entering our domestic market.

Generic drug companies are increasingly turning to foreign countries such as India and China to capitalize on cheap manufacturing and labor costs. Indian operation and production costs are advertised as running 40 to 70 percent lower than developed nations, and labor costs are on average 60 to 70 percent less. With such enticing prices, companies are padding their pockets while supplying a lesser-quality product to patients.

Most alarmingly, issues with data integrity at companies in India and China are increasingly causing doctors to question whether or not the drugs are working the way they’re intended, as the Food and Drug Administration typically counts on drug manufacturers to identify and report problems through company testing. Unfortunately, generics have repeatedly skirted rules and protocol to churn out questionable products for increased profits.

In 2017, the FDA sent a warning letter to one of Mylan’s Indian plants based on concerns surrounding quality controls, with several violations including a failure to “thoroughly investigate” unexplained discrepancies in drug batches. Discrepancies can include active ingredient levels in the drugs being lower than reported or release rates that are inaccurate for the prescribed medication.

In 2018, an Ohio man went into congestive heart failure after his diuretic for an earlier surgery, called torsemide, was switched to a generic brand by a pharmacy benefit manager. The medicine he was switched to was made in India by a company that had been cited by the FDA in 2017 for failing to adequately meet U.S. standards. This scenario could have easily been a West Virginian struggling with heart disease, given a faulty generic drug to ease the cost of a prescription medication.

American lives are the ultimate cost for cheaper generic manufacturing. Continuing to give generic drugmakers undue credit for competing to reduce drug prices threatens critical innovation meant to preserve our country and its people.

Alzheimer’s disease ravages American families and their wallets, and currently there is no cure. It’s estimated that Alzheimer’s disease will cost West Virginia roughly $51.1 billion from 2017 to 2030.

Yet within just five years of a breakthrough treatment, by 2025, there would be $1.8 billion in cumulative health care savings for the state — saving nearly 16,600 lives. Innovation not only saves people, but it saves local economies, as well.

Generics are continuously praised for their success in keeping prices low, but legislators need to focus on how they’re able to achieve these low costs through the use of questionable foreign entities. It’s critical that policy supports the welfare of patients from the pharmacy counter and beyond.

 

Nick Rahall is the longest-serving member in the U.S. House of Representatives from West Virginia and served as chair of the Natural Resources Committee from 2007 to 2011 and ranking member of the Transportation and Infrastructure committee from 2011 to 2015.

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