Outdated regulations are hampering a coronavirus cure

The federal government’s approval process for medicines, treatments, and vaccines is broken, and red tape at the Food and Drug Administration is to blame.

FDA bureaucrats are stonewalling the search for cures for COVID-19 and other illnesses by forcing drug companies to conduct expensive and misleading testing on dogs. The FDA has gone so far as to force this upon drug producers even when it is not necessary, when efficient alternatives are available, and it has punished companies for challenging this mandate.

One company had a drug (now a potential COVID-19 treatment) held up for years and lost tens of millions in stock value because it refused to conduct an unnecessary $750,000 test on dogs after it had already run extensive animal and human testing. The company has argued that “[t]he animal studies the FDA demands … have been considered routine in the pharmaceutical industry for decades, despite the growing body of evidence discrediting such studies’ scientific value.”

The FDA’s current dog-testing mandate for drug companies traces back to 1938, in the days when doctors regularly performed ice-pick lobotomies to treat mental illness and pregnancy tests were done by injecting women’s urine into frogs. Luckily, medicine has come a long way. But even now, although companies may choose to conduct limited animal testing at times, it’s widely acknowledged that animal testing of human drugs is often wasteful and unnecessary.

The National Institutes of Health, for example, writes that “petri dish and animal models often fail to provide good ways to mimic disease or predict how drugs will work in humans, resulting in much wasted time and money while patients wait for therapies.” The NIH, the FDA, and others estimate that over 90% of drugs that pass government-mandated animal tests fail in humans because they are ineffective or dangerous, costing companies billions of dollars and decades of lost time.

Recognizing this waste, in recent years the pharmaceutical industry has increased research & development spending while also decreasing animal testing by using cutting-edge technologies such as organs-on-chips and computer models that better mimic human drug responses.

The problem is that the FDA often won’t allow these new technologies to be used, even though it claims to support them and has the authority to do so. The FDA’s decade-old ”nonbinding” guidance document that includes dog tests also states, “You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.”

Yet, as the Government Accountability Office and others have documented, the intransigent FDA has refused to allow companies to use these high-tech tools to fulfill regulatory requirements. Instead, the FDA treats its nonbinding, outdated guidance as a regulation and forces drug makers to pay for unscientific dog tests that field experts, doctors, and scientists deem misleading and wasteful.

The tests demanded by the FDA cost millions and entail force-feeding puppies experimental drugs every day for up to a year, providing no pain relief, and then killing and dissecting the dogs. Approximately one-third of all dog testing in the United States is done to fulfill useless and burdensome government regulations such as these.

These slow and misleading tests also cause unnecessary delays that drive up the cost of drug development and, in turn, medical care. Estimates are that each day a drug is kept off the market due to FDA bureaucracy costs companies between $1 million and $13 million in sales. The GAO has also reported about how safe and effective medical products have been kept from consumers because of FDA’s unnecessary animal testing demands and that “manufacturers may face backlash from animal rights groups and shareholders if animal testing is conducted.” The FDA’s dog-testing red tape is creating liability, not mitigating it.

Taxpayers who pay the FDA’s bills want reform, too. According to a May 2020 national poll, 67% of taxpayers — 73% of Republicans and 66% of Democrats — support ending the FDA’s dog-testing mandate.

In the fight against COVID-19, President Trump has called on the FDA to “slash red tape like nobody’s ever done before.”

The FDA’s burdensome dog testing, which is not required by law and could be lifted at any time, has allowed dangerous drugs to reach patients and prevented safe ones from coming to market. FDA red tape can’t be allowed to hold patients, industry, and puppies hostage any longer.

Originally published here.


The Consumer Choice Center is the consumer advocacy group supporting lifestyle freedom, innovation, privacy, science, and consumer choice. The main policy areas we focus on are digital, mobility, lifestyle & consumer goods, and health & science.

The CCC represents consumers in over 100 countries across the globe. We closely monitor regulatory trends in Ottawa, Washington, Brussels, Geneva and other hotspots of regulation and inform and activate consumers to fight for #ConsumerChoice. Learn more at consumerchoicecenter.org

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