FDA: Goal is to be seal of trust

The Food and Drug Administration just approved the Pfizer vaccine (now marketed as Comirnaty) — months after millions of Americans got one.

Wait, what?

Normally, it can take years for a new drug or vaccine to be approved. It has to go through a lot of scientific rigor with medical trials, risk analyses, reviews and bureaucratic layers before final FDA approval permits its sale and approved uses.

Obviously, the COVID-19 whammy rushed us through in the face of a pandemic, with conditional “emergency use” approvals for three vaccines in late 2020. To wait another year would likely have meant more cases, deaths and overwhelmed medical staff.

Now that things are formalized, officials hope vaccinated rates will inch up. Time will tell.

It does beg the question: What is the FDA?

Meant to ensure the safety of America's food, cosmetics, drugs and medical devices, the Food and Drug Administration’s network of roughly 15,000 employees regulate, research and inspect $1 trillion worth of products annually for people and animals. “FDA approved” aims to be a seal of trust, a sign something has been deemed scientifically, medically and nutritionally sound by qualified experts.

While part of its history traces back to the 1848 creation of the Agricultural Division in the Patent Office, its role as a federal consumer protection agency began with the 1906 Pure Food and Drugs Act under President T. Roosevelt — a quarter-century culmination of legislative efforts to rein in long-standing abuses in the food and drug marketplace.

When the Industrial Revolution turned food and medicine production into large-scale operations, newly invented canning meant foods could sit on shelves for extended periods. Untested and unregulated “patent medicines" were sold in catalogs claiming a variety of cures. Consumers couldn’t know how old the food was, or how baseless the medical claim.

Exploitation became a big problem. Spices or additives masked expired meat or substandard ingredients. Many patent medicines relied on large quantities of morphine or cocaine to substitute a high for healing. People got sick; some died.

Public appeals and an active lobby of mothers created pressure, but it wasn’t until someone from the inside took action that change occurred. Scientist Harvey Wiley, head of the USDA's Bureau of Chemistry, worked in farming support, but his passion was food and medicine safety.

Bolstered in his crusade by the work of two journalists — Upton Sinclair's “The Jungle,” an exposé documenting inhumane labor conditions and horrifically unsanitary production of many processed foods, and Samuel Hopkins Adams’ exposé on the dangers of the patent medicine industry — Wiley and supporters finally saw the Pure Food and Drugs Act become law on June 30, 1906.

Generally, that law forbade hazardous materials and concealed problems in food, and required accurate, truthful labeling of ingredients which aren’t misleading. Dangerous ingredients such as alcohol, heroin and cocaine had to be listed. Obviously those last two aren’t allowed today.

Nicknamed the Wiley Act, regulatory authority first went to Wiley's Bureau of Chemistry, later reorganized into today’s FDA (so named in 1930). Historically, most FDA leaders have been doctors, appointed by the president with consent of the Senate.

Currently the FDA regulates:

· (About) 78 percent of the U.S. food supply — everything we eat except for meat, poultry and some egg products.

· 20,000 prescription drug products

· 6,500 different medical device product categories.

· 1,600 FDA-approved animal drug products.

· 300 FDA-licensed biologics products.

· 90,000 tobacco products, not including e-liquids.

The FDA doesn’t approve every drug, rejecting infamous ones such as thalidomide, given in Europe for morning sickness but found to cause birth defects.

Over time and responding to public outcry and horror stories, authority expanded to cover devices and other dangers, eventually banning things such as death-inducing radium in manufacturing, cosmetics with blinding dyes and false promises (such as an antifreeze analogue which killed children), some leading people to forego life-saving alternatives.

Of course, agencies are as imperfect as people. Lives are saved and also harmed by mistakes, hesitance and rush. Criticism includes approval of certain opioid medications with allegedly insufficient attention to their addictive properties, and in recent cases, other drug approvals happening too rapidly. Balancing public needs, safety, conflicting pressures and lobbies is tricky business.

Today, the agency has a federal budget of about $5 billion, with more than 170 district and field offices and labs overseeing $2.8 trillion in food, devices, and drugs.

Its jurisdiction encompasses most food products (other than meat and poultry); human and animal drugs; therapeutic agents of biological origin; medical devices; radiation-emitting products for consumer, medical and occupational use; cosmetics; and animal feed. The agency oversees items accounting for more than 20 cents of every dollar spent by consumers.

For more information see FDA.gov.

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Sholeh Patrick is a columnist for the Hagadone News Network. Email Sholeh@cdapress.com.