Time to Think Twice About Importing Drugs
When importing prescription medications, whether branded or generic, vigilance should be required. Pharmaceutical companies can tell you many reasons generics are important and why they are safe. But the reality of the Federal Drug Administration’s (FDA’s) promise of safety needs to be carefully monitored.
There’s much that the public hasn’t learned about prescription pharmaceuticals, both branded and generic. For example, when we trust the quality of our medications manufactured in other countries, we need to be doubly diligent. Years ago, I worked at a hospital that purchased cheap mouthwash from a Third World country. The mouthwash was contaminated with a deadly bacterium, which was eventually discovered, but not before several innocent patients had died from using the mouthwash while in the hospital.
In December of 2022, the World Health Organization (WHO) linked Indian-made cough syrup to the acute kidney failure and deaths of 66 children in west Africa. WHO’s laboratory analysis said the cough syrups contained “unacceptable amounts of diethylene glycol, (PEG) and ethylene glycol (EG),” chemicals meant for industrial use only.”
Back in 1937, the U.S. pharmaceutical company S.E. Massengill introduced a new liquid form of the antibiotic sulfanilamide. The product was marketed as Elixir Sulfanilamide. It contained diethylene glycol (DEG), a toxic substance often used as antifreeze. This solvent lead to severe kidney failure and deaths in over 100 people, many of them children. This tragic series of events prompted the enactment of the Food, Drug and Cosmetic Act of 1938 which significantly increased the FDA’s powers to regulate drugs, and required proof of safety before the release of the new drugs. A recent ProPublica article “Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs” suggests three ways the FDA fails in its job:
·Risky Medications: The FDA has given more than 20 foreign factories a special pass to continue sending drugs to the U.S. even though they were made at plants that the agency had banned.
·Troubled Factories: The medications came mostly from plants in India where inspectors found contaminated drugs, filthy labs and falsified records.
·FDA Secrecy: The agency did not proactively inform the public when drugs were exempted from import bans, and it did not routinely test the medications to ensure they were safe.
The ProPublica authors report on the example of Sun Pharma in India:
The Food and Drug Administration imposed one of the government’s harshest penalties: banning the factory from exporting drugs to the United States….But the agency, worried about medication shortages, immediately undercut its mission to ensure the safety of America’s drugs supply….A secretive group inside the FDA gave the global manufacturer a special pass to continue shipping more than a dozen drugs to the United States even though they were made at the same substandard factory that the agency had officially sanctioned.
According to the article, the FDA chose to accept potentially dangerous drugs rather than run short of medications. Janet Woodcock, now retired, oversaw the FDA for 40 years. In the ProPublica interview with Janet Woodcock, she said she believed drugs coming into United States, even though banned, were safe. Even though the FDA did not routinely test the drugs for safety. She said she “has supported the use of exemptions as a “practical approach.”
Keep in mind that 80 percent of our branded medications come from other countries and approximately 90 percent of our generics coming from other countries. Although some of the drugs don’t come directly from China, many of the ingredients to make the drugs in other countries often do come from China.
The fact that we don’t manufacture our own branded and generic prescription medications in this country is dangerous. To compound the problems, many of our hospital necessities like IV solutions, tubing, and masks come from China.
Importing prescription drugs did not really take off until the early 2000s. At that time, importing branded prescription drugs bypassed high U.S. prices. Importation began through online pharmacies and some branded prescription drugs actually came from Canada, which sometimes had imported those medications from the U.S. Cycling drugs through Canada was still cheaper than buying them directly from the U.S. pharmaceutical companies. We wrote about this practice 34 years ago in Modern Medicine. The online pharmacies and importation process emerged as a way to access medications at a lower cost. To save money on the cost of drugs, importing generic prescription drugs began to increase alongside importing branded prescriptions.
The University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) reports details where top 100 brand-name prescription drugs are made.
Although we are told the country of origin of our clothing, food or computer products, there is no federal requirement for revealing the country-of-manufacture for brand-name prescription medications.
CIDRAP explains there’s a difference between active pharmaceutical ingredients and the finished product. Of 100 brand name drugs, 32 are finished in the United States, while 67 are finished in other countries from Canada, Japan, Singapore, Switzerland, and the United Kingdom. Our generic drugs are typically made in Asian countries such as India, China, and Japan.
The CIDRAP article suggests the following to provide greater safety in our drug supply:
Mandate clear identification of the country of origin of a drug's contents as well as thefinished drug formulation,
Pass laws to allow companies other than their manufacturers to import brand-name prescription drugs from countries with strict pharmaceutical regulations,
Ensure that lower-cost generic drugs are used in the Medicare program rather than their more expensive brand-name counterparts,
Require that the FDA publish an annual report with accurate data on drugs and ingredients by country of origin,
Work toward greater global collaboration and coordination to better regulate and ensure safe drug manufacture and high-quality ingredients, and
Mutually evaluate threats stemming from reliance on the Chinese pharmaceutical supply chain among democratic allies.
Prescription medications in the U.S. involves big money, reaching $722.5 billion in 2023, a 13.6 percent increase compared to 2022. Spending on retail drugs reached 42.2 percent of the total drug spending in 2021. The global pharmaceutical market is estimated at around 1.6 trillion for 2023 and is projected to reach 1.92 trillion by 2027. The pharmaceutical industry is very big business.
A recent Medscape article addresses the issue of tariffs on medications. Imported medications have never been subjected to tariffs and while President Trump has talked about encouraging U.S. manufacture of drugs by putting tariffs on imports, that hasn’t happened. According to this Medscape article, most branded medications are manufactured in Europe, many of them in Ireland. Indeed, Ireland pays less for the branded drugs manufactured in their country than the U.S. pays for the same drug upon import. The question is why no one is looking into this. The generics are generally manufactured in Asian countries. Those interviewed for the article claim it would take two years to begin being able to manufacture drugs in this country that we currently import. That’s no excuse to not begin the process of beginning the transition now.
Bringing the manufacture of our prescription drugs, branded, and generic, back to the U.S. would have several benefits. First, prescription drug manufacturing in our country would decrease our unemployment rate remarkably, adding positively to our gross national product and securing greater financial stability for many workers in the U.S. Thousands of people could have decent jobs manufacturing prescription drugs. Secondly, the manufacture of prescription drugs within the United States could more easily ensure quality and safety as long as the FDA were required to be transparent in their decisions, no longer allowed to make secret decisions which weren’t in the best interest of patients. Thirdly, we would not be dependent on supply chain shortages, intentional or unintentional, caused by other countries.
In my opinion, returning the manufacture of branded and generic prescription drugs to our country should be a state and national priority of the first order.