Foreign laboratories and factories dominate American drug market, while FDA flounders

If you thought the American people were the customers of the U.S. Food and Drug Administration (FDA), you were wrong

Human Drugs regulatory activities account for 33 percent of FDA’s budget; 65 percent of these activities are paid for by industry user fees, boasts the FDA website.

No surprise: the 15,000 employees of the FDA might act like representatives of Big Pharma, when it comes to telling the public what it needs to know, and what the drug companies prefer kept secret. A good example: the bottle from the pharmacy containing your prescription pills. Look for the country of origin, You won’t find it, even though it’s on just about every other item you purchase. The Government Accountability Office (GAO) reported this month that 75% of our pharmaceutical inputs (API) and 54 percent of finished doses come from outside our country. Guess who is the biggest culprit and beneficiary of FDA regulation rules?

China has aggressively under-priced its products to such a point that it has now made itself the exclusive supplier for critical ingredients for dozens of crucial pharmaceuticals, including: antibiotics, diabetes and heart-disease drugs, plus high-blood pressure medicine, according to testimony given at a 2019 U.S.House energy and commerce hearing. Even India is dependent on China for ingredients.  Essentially all generic drugs – which account for at least 90 percent of the drugs dispensed from pharmacies — rely on raw pharmaceutical ingredients originating in China.

The FDA is responsible for inspecting those foreign facilities, but they have not inspected more than a handful in nearly a year. Compare that to 2019 when 977 foreign drug sites were examined. Foreign inspections surpassed domestic ones in 2014-15 for the first time, many of those occurring in India and China. But since 2016, inspections have declined due to staffing issues created by Congress and the bureaucracy. In 2020, only inspections deemed “mission critical” were ordered. The GAO report said long-known problems included giving foreign labs as long as 12 weeks to be ready for inspectors, and nearly no fines or other punishments, including import bans for labs with warning letters from the FDA. From March 2020 to January 2021, FDA conducted only three foreign mission critical inspections – just one in Canada, Germany, and India. There were no inspections in China. In each of the prior two years, the agency conducted more than 900 foreign drug factory inspections. During the last two decades, cheap labor costs and heavy regulation have driven the majority of American pharmaceutical manufacturers to move operations overseas to increase profits and avoid FDA inspections. As a result, thousands of talented American scientists have lost their jobs. Promoting STEM has taken a backseat to investor greed. Jeff Fortenberry, (R-NE) said the current foreign inspection program with three-month warnings gives American labs an uneven playing field.

The 12-week period is enough time to for labs to clean up their act, This is an uneven playing field for those trying to manufacture in the US. Why has so much moved overseas? To capitalize on low wages and lackluster labor standards in part, but I wonder if US law is encouraging it? Made in America should apply more than to just our military. We are inordinately dependent on API and final products from overseas, and I’d like to see Made in America on our prescription drug products.

Xarelto sold in the U.S. has its active ingredient made in Germany. The finished product is manufactured in Puerto Rico (USA), according to Pharmacy Checker. A drug’s raw ingredients (the actual chemical in the medicine, as well as the binders, fillers and colors) may all come from different countries. The Active Pharmaceutical Ingredient (API) may be made in China, while the coloring agent may come from India and the fillers (other inactive ingredients) are from Thailand. What is the country of origin? Is it China where the API was made, or maybe Brazil or Thailand, where the final dosage form is created and stamped? No matter where the drug we take is made, we pay more. Xarelto’s average list price is $552 a month in our country, versus the lowest international price of $60. Who says Americans don’t overpay for drugs?

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Mary Denigan-Macauley, the director of healthcare and private markets at the Government Accountability Office (GAO), seems slightly concerned about lack of inspections and country of origin labels.

Look at your generic pill bottle. It rarely has a manufacturer listed. It rarely has a lot number, so it is impossible to tell when or where it was made or what batch it belonged to. The discard date is almost always one year from the day it was dispensed. In other words, there is NO expiration date on the label. The discard date is computer generated and has no relationship with the actual expiration date of your pills.

Rapoza said that “if you experience a problem with the pills and want to report that concern to the FDA, the agency will ask for the Manufacturer, the Lot number, the NDC number (National Drug Code unique product identifier) and the Expiration date.

Here is a link to download the Voluntary_Reporting_form-FDA-3500B so you can see for yourself. In other words, the FDA requires information from consumers that it is virtually impossible to supply for a generic medication, Rapoza added.

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Dr. David Gortler, of the Ethics and Public Policy Center in Washington DC, has a far more brutal criticism of drug regulation. He heads the FDA branch of the HHS Accountability Project.

Most Americans would be shocked to hear that the FDA does not currently perform any of its own independent checks in the form of real-time “release testing” (RTRT) of drugs imported from foreign countries to certify that they contain the proper milligram strength and are uncontaminated, Gortler explained. Pharmacists and physicians are still living in the 1980s, when all pharmaceutical manufacturing was in-county, conducted by accredited staff and under the watchful eye of the FDA, and aren’t taught to be concerned about the quality of drugs they prescribe and dispense. When adverse events or unanticipated clinical responses emerge, they don’t consider the possibility of shoddy quality; they instead take the listed milligram strength as sacrosanct, and take quality as a given.

Gortler said that “despite well-known quality and purity issues, large chain pharmacy buyers and Pharmacy Benefit Managers (PBMs) only seem interested in cost when it comes to fulfillment of their insurance contracting requirement.”

Chain pharmacies and PBM insurance companies are quite content giving their insured patients the absolute cheapest Chinese-made generic drugs they can find, FDA overseas violation reports notwithstanding.

In January President Joe Biden watered down the price cuts planned for prescription drugs and he is not expected to push FDA to better serve the American people with origin labeling that might offend China and Big Pharma.

Read: Inside China’s Illegal Drug Production!