The Food and Drug Administration (FDA) is responsible for protecting public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.

Consumers rely on the U.S. Food and Drug Administration to provide independent scientific reviews of medical products, including therapeutic drugs and vaccines. To meet the urgent need for products to treat or prevent COVID-19, the FDA has approved and authorized several preventative drugs, including vaccines and treatments.

Before the FDA can approve a drug, the agency must determine whether the clinical data and other scientific information show that the drug is safe and effective for its intended use (for example, to prevent or treat a certain disease) and that the product can be made according to federal quality standards.

When the FDA approves a drug, it means the agency has determined that:.

• The drug is safe and effective for its intended use.
• The benefits of the drug outweigh its risks when used according to its approved labeling.

There is perhaps no more important public health agency in the world than the US Food and Drug Administration (FDA). Its policies have reshaped science and regulation worldwide, giving billions of people greater confidence in the treatments and foods on which they rely. Yet the agency’s capacity and autonomy — and hence the services it renders — are in jeopardy.

The history of the FDA

The United States Food and Drug Administration (FDA) was first created to enforce the Pure Food and Drug Act of 1906. In this capacity, the FDA is charged with protecting the health of the US public, to ensure the quality of its food, medicine, and cosmetics. Before this time, the United States government had no formal oversight of these products and left issues of quality and purity to the individual manufacturers, or at times, individual states.

This lack of regulation was not much of a concern during the early years of the country, as most people made their own goods, or purchased them from locally owned shops (who would make their own products). However, as more people moved into cities to work in factories and other urban jobs, pre-made goods were needed as city dwellers could not produce these themselves.

The precursor to the FDA was established in 1906 by the Pure Food and Drugs Act under the “Bureau of Chemistry,” which had been created by Abraham Lincoln. Its original mission was to stop the sale of falsely advertised or unsafe food and drugs. At the time, unregulated patent medicines were flourishing as the result of new marketing and advertising techniques that are still used today. The department got its current name, the Food and Drug Administration, in 1930 and now oversees more than $2.6 trillion worth of food, medical products, and tobacco.

Out of the more than $3 billion budgeted for the FDA, about $2 billion is derived from user fees paid by manufacturers, with the remainder by government appropriation. User fees, which were instituted in 1992, speed up approvals, but some regard them as creating undue influence on the process by companies and politicians. The FDA uses about a third of the budget for drug regulation, while 10% is dedicated to oversight of medical devices and their radiation emissions. Biologics come in at about 7%. About 20% of the FDA budget goes to food safety, with the remainder spread across regulation of animal medicine, tobacco products, and administrative costs.

In the early 20th century, food began to be sold on the mass market for the first time, and safety issues were rampant. The government began to step in and today, the FDA regulates more than three-quarters of the U.S. food supply. The exceptions are meat, poultry, and some egg products, which are overseen by the Department of Agriculture. The FDA’s food code is used to oversee more than a million restaurants, grocery stores, vending machines, and cafeterias. Food suppliers must test and monitor their products according to FDA standards, and report sanitation and contamination problems.

Is it possible that it fails?

Antibiotics

Every year, antibiotic-resistant infections kill at least 23,000 Americans and make another two million sick, according to the Centers for Disease Control and Prevention. That’s why a recent ruling by the United States Second Circuit Court of Appeals is so appalling.

It allows the federal Food and Drug Administration to leave an antibiotic used in animal feed on the market even if the agency openly states that the drug’s use is not safe and increases the risk of antibiotic resistance in people. This means that the dangerous misuse of antibiotics in industrial livestock and poultry can continue unabated.

For years industrial meat and poultry producers have fed healthy animals antibiotics to fatten them up fast. The antibiotics also prevent disease in what are often overcrowded, unsanitary conditions. This practice breeds antibiotic-resistant bacteria that threaten us all.

The F.D.A. has issued a toothless voluntary guidance document for the industry, which requires no action to reduce antibiotic use and will therefore do little to nothing to stop the spread of antibiotic-resistant superbugs.

Food safety

Ongoing food monitoring by the U.S. Food and Drug Administration of toxic heavy metals like lead, arsenic, cadmium, and mercury revealed some concerning levels in the U.S. food supply — with certain baby foods having the most detectable levels of arsenic and lead.

Such heavy metals can negatively affect a baby’s brain development and are among the most common metals that get into food, according to the U.S. Centers for Disease Control and Prevention and the American Academy of Pediatrics (AAP).

These heavy metals are found naturally in the Earth’s crust and are also released into the environment as pollution that gets into the water and soil used to grow food, according to the AAP. The toxins can also get into food from food manufacturing and packaging.

The FDA’s Total Diet Study Report summarizes the findings after sampling over 3,200 food and beverage products between the fiscal years 2018 through 2020. It found that almost one-third (32%) of the foods tested contained toxic elements lead, arsenic, cadmium, and mercury.

Of all the foods tested, the highest levels of lead were found to be in baby food sweet potatoes and teething biscuits, in addition to sandwich cookies and white wine.

Roughly 51% of the baby food samples analyzed had detectable levels of “total arsenic” found in infant cereals and snacks like teething biscuits and puffed snacks.

Arsenic is a naturally occurring element. Inorganic forms of arsenic are dangerous and associated with more severe health effects than organic arsenic, although the toxicity of organic arsenic is also being actively studied, the FDA notes.

Foods with the highest levels of inorganic arsenic noted in the report were foods babies and children eat, including crisped rice cereal, baby food rice cereal, puffed snacks, white rice, and baby food mixed multi-grain cereal.

Despite the agency concluding years ago that babies’ and young children’s smaller bodies and metabolisms make them more vulnerable to the harmful effects of toxic metals, FDA has established only one action level, or amount of toxic metal in a product at or above which FDA will remove the product from the market, for one type of toxic metal (inorganic arsenic) in one type of baby food product (infant rice cereal) to date. Under current FDA policy, baby food manufacturers are left to decide whether or not to even test their products for toxic metals and other contaminants.

Parents count on baby food to be safe and healthy for their little ones. The FDA has known for years that baby foods can contain lead, arsenic, and other heavy metals that can harm brain development. But their failure to set low limits and to require end-product testing has led to profound, real world suffering for hundreds of families across the country, including almost 50 in New York State alone.

Baby formula

A recent recall of infant formula was announced nearly three months after Food and Drug Administration officials first learned that some products at a major plant had tested positive for bacteria — a delay that mirrors the agency’s slow response to reports of food safety problems and infant deaths ahead of last year’s massive recall over the same type of bacteria.

In late February, formula giant Reckitt issued a press release recalling 145,000 cans of Enfamil ProSobee Simply Plant-Based Infant Formula over the “possibility of cross-contamination with Cronobacter sakazakii” — the deadly pathogen that sparked the infant formula crisis last year. Dozens of news outlets covered this as breaking news, recommending parents and caregivers toss the products or return them for a refund.

Reckitt had found Cronobacter sakazakii in a batch of formula made at its Zeeland, Mich., plant, during internal testing conducted in early September. The batch that tested positive was destroyed, but the FDA later determined that not enough cleaning had been done following the positive test. Two batches of formula made right after the contaminated batch would ultimately be recalled on February 20 — more than five months after the products had been distributed nationally, including in Guam and Puerto Rico.

The revelation that this recall took months to announce comes more than a year after a massive infant formula recall from Abbott Nutrition, renewing questions about FDA’s oversight of formula and whether enough has changed in the wake of this crisis to prevent another one. There have been four formula recalls over Cronobacter contamination in the past year — more formula recalls than there have been in the last decade combined.

The FDA, for its part, has over the last year been taking a closer look at formula makers’ own records during food-safety inspections as a response to last year’s incident, which was initially set in motion by reports of four infant illnesses, including two deaths, from Cronobacter infections. FDA officials later found serious food safety violations at Abbott’s Sturgis, Mich., plant, which was shuttered for months for cleaning and upgrades, fueling a national shortage and a major disruption to the market because the plant had once made roughly a fifth of the U.S. supply. The FDA also found Cronobacter in 20 places in the plant, though none of the strains matched the illnesses.

The opioid crisis

In the United States, opioid use disorder (OUD) and opioid overdose were once rare. But over the past 25 years, the number of Americans suffering from OUD increased exponentially and in parallel with an unprecedented increase in opioid prescribing. Today, OUD is common, especially in patients with chronic pain treated with opioid analgesics, and opioid overdose is the leading cause of accidental death.

The high prevalence of OUD has led to an array of health and social problems. The United States has seen record-high rates of neonatal opioid withdrawal syndrome, more children entering foster care, rising heroin and fentanyl use, outbreaks of injection-related infectious diseases, and a decline in workforce participation in areas with relatively high rates of opioid prescribing. The Centers for Disease Control and Prevention (CDC) has aptly described the crisis as the “worst drug overdose epidemic in [US] history.”

The Food, Drug, and Cosmetic Act requires drug manufacturers to demonstrate that their products are both safe and effective before they are marketed. The benefits of a drug must outweigh the potential risks for specific indications listed on an FDA-approved label. Although prescribing medication for unapproved uses is common and sometimes appropriate, drug makers are prohibited from promoting off-label uses without premarket review by the FDA.

The FDA did not properly enforce the Food, Drug, and Cosmetic Act when it approved Purdue Pharma’s new drug application for extended-release (ER) oxycodone in 1995. Had it done so, ER oxycodone’s label would have had a narrow indication of the specific conditions for which the benefits of ER oxycodone outweigh the risks, such as relief from severe pain from a life-limiting illness. Instead, the label on ER oxycodone featured a broad indication, allowing Purdue to promote the drug’s use for common conditions for which opioids are more likely to harm than help, such as low-back pain and fibromyalgia.

As Purdue earned billions of dollars from sales of oxycodone, other drug companies took note. They introduced their own opioids and joined Purdue in funding a brilliant, multifaceted campaign that changed the culture of opioid prescribing in the United States. Clinicians who previously understood that opioids are addictive, that development of tolerance results in dose escalation, and that dependence would make discontinuation difficult began hearing from spokesmen for opioid manufacturers that addiction was rare and that long-term use was safe and effective. Risks were minimized, benefits were exaggerated, and opioid prescribing surged.

The FDA has never been held to account for its improper handling of the opioid crisis. But the FDA’s conduct is all the more troubling in light of the close relationship between the agency officials responsible for opioid oversight and opioid manufacturers. For example, the 2 principal FDA reviewers who originally approved Purdue’s oxycodone application both took positions at Purdue after leaving the agency. Over the past 20 years, several other FDA staff involved in opioid approvals also left the FDA to work for opioid makers.

While fewer clinicians are initiating long-term opioids, overprescribing is still a problem. According to a recently published report, more than 2.9 million people initiated opioid use in December 2017. The FDA’s continued approval of new opioids exacerbates this problem. Each time a branded opioid hits the market, the company, eager for a return on its investment, is given an incentive and, in essence, a license to promote aggressive prescribing. The FDA’s continued approval of new opioids pits the financial interests of drug companies against city, state, and federal efforts to discourage the initiation of long-term opioids.