Most foreign regulatory agencies can ban bad drugs if they detect a problem with quality. The blood pressure drug valsartan was found to be contaminated with a probable cancer causing chemical in the summer of 2018. The European Medicines Agency (EMA) demanded the removal of lots of problematic valsartan. The FDA, on the other hand, relied upon a “voluntary” recall. Why can’t the agency ban bad drugs?
The Government Bans Lots of Things:
Bump Stocks:
The government bans things it perceives as dangerous. The U.S. Justice Department banned bump stocks in December 2018. That was because a gunman in Las Vegas fired over 1,100 rounds of ammunition, wounding 413 people and killing 58 in 2017. Bump stocks convert a semiautomatic rifle into a rapid-fire gun, almost as fast as a machine gun.
Boeing 737 Max:
After two tragic crashes of the Boeing 737 Max, the airplane was grounded worldwide. In conjunction with regulators in many other countries, the Federal Aviation Administration (FAA) banned the plane in March, 2019. After nearly two years of intense scrutiny and improvements, the FAA will now permit the Max to fly again.
Powdered Gloves:
The Food and Drug Administration banned powdered medical gloves in January, 2017 after determining that the powder contributes to wound inflammation and post-surgical scar tissue. Surgical and exam gloves no longer come powdered.
The FDA Can’t Ban Bad Drugs:
We wish the FDA could ban bad drugs and protect the American public. We think the agency should have this kind of authority to oversee the nation’s drug supply and remove unsafe products. Few people realize that the nation’s drug watchdog has no teeth. That is to say, the agency cannot ban bad drugs and force companies to remove from them from the market. Most other countries are way ahead of us in this regard.
The Hand Sanitizer Debacle:
This lack of authority was highlighted recently when unscrupulous companies started selling hand sanitizers containing methanol instead of ethanol during the pandemic.
Alcohol-based hand sanitizers have been in high demand ever since COVID-19 started. Ethanol (ethyl alcohol) is the ingredient in many antiseptics, hand sanitizers and alcoholic beverages.
Wood Alcohol in Hand Sanitizers:
Methanol (methyl alcohol) is a close chemical relative to ethanol. It is also known as wood alcohol. It has been responsible for blindness, respiratory paralysis and thousands of deaths over the decades. This highly toxic form of alcohol was especially problematic during Prohibition.
Because of ethanol shortages during the pandemic, some manufacturers substituted methanol instead in their hand sanitizers. At least 17 people died as a consequence of exposure to these products. Others were blinded.
FDA Warns About but Can’t Ban Bad Drugs:
The FDA issued numerous warnings. For example, the agency alerted the public that (“FDA updates on hand sanitizers consumers should not use,” Jan. 19, 2021):
“FDA is warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.”
“Methanol is not an acceptable ingredient for hand sanitizers and must not be used due to its toxic effects. FDA’s investigation of methanol in certain hand sanitizers is ongoing. The agency will provide additional information as it becomes available.”
FDA officials lists more than 100 dangerous hand sanitizers from countries such as Mexico, Guatemala and China. It warns consumers to avoid products it identifies as contaminated. Here is a link to a list of contaminated products. What the agency could not do, however, was force companies to recall tainted products.
Why Can’t the FDA Ban Bad Drugs?
You read that correctly. We know it seems bizarre, but the FDA lacks authority to actually ban contaminated pharmaceutical products from the market.
The Food and Drug Administration can recall food that has been contaminated with dangerous bacteria. If infant formula is adulterated, the FDA can demand it be removed from grocery shelves. But the FDA does not have the power to pull bad drugs off pharmacy shelves.
Nitrosamines in Medications:
In recent years, a lot of medications have been contaminated with probable carcinogens. Many blood pressure pills such as valsartan, losartan and irbesartan were found to contain nitrosamines.
The heartburn medicine ranitidine (Zantac) was also recognized as a problem. More recently, a number of extended-release metformin formulations were also found to be contaminated. This is the most commonly prescribed diabetes drug in the country. Here is a link to our article on metformin messes.
When the FDA discovers that a pharmaceutical manufacturer has a problem with quality, it asks the company to recall the product. Many times, companies do agree to a “voluntary” recall. But if a company chooses to ignore the FDA’s request, the agency has no power to enforce its entreaty.
Please Ban Bad Drugs!
A year ago, Representative Rosa DeLauro of Connecticut reintroduced her legislative initiative:
“Recall Unsafe Drugs Act”
“The Recall Unsafe Drugs Act would enable the FDA to step in and issue a mandatory recall of products that have been found to cause serious health consequences or death.”
Does that seem too radical? We don’t think so.
But the FDA does not seem interested in asking Congress for more authority over contaminated or substandard drugs. In essence, the FDA does not want the power to ban bad drugs.
Congress seems unwilling to support this legislation. We do not understand this. Could it be that drug manufacturers that spend a lot of money lobbying Congress do not support this bill either?
While some of the methanol-containing hand sanitizers on the FDA’s list have been voluntarily recalled, others have not. It is discouraging that the agency cannot compel the removal of contaminated sanitizer, ranitidine, metformin or other products that endanger the public health.
What Do You Think?
Should the FDA be given the authority to ban bad drugs? If you think Representative Rosa DeLauro’s “The Recall Unsafe Drugs Act” deserves support, please write to her office:
United States Representative Rosa DeLauro
Third District of Connecticut
2413 Rayburn House Office Building
Washington, DC 20515
