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The FDA’s History Highlights the Stakes of Drug Regulation Limbo: A Familiar Challenge to the Agency’s Authority


Political pressure is nothing new to the US Food and Drug Administration. The agency has often come under fire for its drug approval decisions, but attacks on the decision-making process and science itself have increased during the COVID-19 pandemic.

Recent challenges to FDA authority have emerged in the context of reproductive rights.

On November 18, 2022, a group of anti-abortion doctors and medical groups filed a lawsuit to the FDA, which contested the approval more than 20 years ago of mifepristone, a drug taken in combination with another drug, misoprostol, to treat miscarriages and used to more than 50% of abortions in early stage pregnancies in the US

It is widely believed that the plaintiffs filed the lawsuit in the Northern District of Texas, so District Judge Matthew J. Kacsmaryk, a known opponent of abortion, could oversee the trial. While Kacsmaryk issued a preliminary injunction that the FDA lacked the authority to approve mifepristone, an appeal partially reversed the decision and the Supreme Court stopped Kacsmaryk’s order. The case is now in the US 5th Circuit Court of Appeals and is likely to return to the Supreme Court.

The FDA is the oldest government consumer protection agency. The ramifications of this lawsuit could extend far beyond mifepristone — undermining the agency’s authority could jeopardize the entire drug approval process and alter access to commonly used drugs ranging from amoxycillin and Ambien to prednisone and Paxlovid .

I’m a lawyer whose research focuses in part on the law and ethics of the FDA drug approval process. Examining the FDA’s history reveals the unprecedented nature of the current challenges to the agency’s authority.

Then, FDA Commissioner George Larrick used this chart during Senate testimony in 1964 to illustrate the array of sources the agency uses when evaluating proposals.
The US Food and Drug Administration/Flickr

Events shaping the FDA’s focus on safety

In its early years, the FDA focused primarily on balancing the competing goals of consumer safety with access to experimental treatments. The priority was to strengthen consumer protection to prevent a recurrence of a tragedy.

For example, at the beginning of the 20th century, Congress passed the Biologics Control Act of 1902, which empowers the federal government to regulate vaccines. This law was introduced after 13 children died from accidentally contaminated diphtheria antitoxin, which was made from the blood of a horse infected with tetanus.

A few years later, after investigative journalists published the unsanitary conditions and food handling practices in meatpacking plants, Congress passed the Pure Food and Drug Act of 1906which banned the marketing and sale of mislabeled and contaminated food, beverages and drugs.

Similarly, in 1937 about 71 adults and 34 children died from ingestion SE Massengill’s Antibacterial Elixir, which contained a poisonous raspberry flavor added to sweeten the taste. In response, Congress passed the Federal Food, Drug, and Cosmetic Act of 1938, which requires manufacturers to demonstrate that drugs are safe before they reach the market. This act marked the beginning of modern drug regulation and the birth of the FDA as a regulatory agency.

FDA scientist Frances Oldham Kelsey’s decision not to approve thalidomide for use in the US protected Americans from birth defects faced by newborns in other countries.

Then, in 1962, Dr. Frances Oldham Kelsey, a pharmacologist, physician, and medical officer who worked at the FDA, refused to approve thalidomide, a drug marketed in Europe, Canada, Japan, and other countries to relieve morning sickness in pregnant women, but later found to cause serious birth defects. Shocking revelations of children born without limbs or suffering from other debilitating conditions motivated Congress to pass the Kefauver-Harris drug amendments of 1962, which ushered in a more cautious approach to the drug approval process.

The FDA’s turn to expand access

In the 1970s, questions about the limits of safety versus an individual’s right of access arose when cancer patients seeking access to an unapproved drug derived from apricots, Laetrile, sued the FDA. The agency had blocked the shipment and sale of the drug because it was not approved for use in the US. maintained FDA’s protective authoritywhere an unproven therapy is assumed to be unsafe for all patients, including the terminally ill.

However, the 1980s mark the FDA’s shift to greater access after reports of an emerging disease – AIDS – that primarily affected gay men. In the first nine years of the AIDS epidemic more than 100,000 Americans died. AIDS patients and their advocates vocal critics of the FDAarguing that the agency was too paternalistic and restrictive after events such as the thalidomide scare.

ACT UP demonstrators lie on the floor with tombstone-shaped signs demanding that the FDA allow access to experimental HIV/AIDS drugs
Protests by HIV/AIDS activists such as ACT UP urged the FDA to develop accelerated drug approval pathways to meet urgent public health needs.
Mikki Ansin/Peter Ansin via Getty Images

After massive protests, Dr. Anthony Fauci, then director of the National Institute of Allergy and Infectious Diseases, proposed a parallel track program allow eligible patients access to unapproved experimental treatments. This, along with other existing FDA mechanisms, helped pave the way for other alternative routes of approval, such as emergency use authorization, which was instrumental in allowing the use of vaccines and drugs pending full FDA approval. approval during the COVID-19 pandemic.

Future of the FDA

Despite the FDA’s shift towards greater access, the the political right has argued in recent years that the agency remains too bureaucratic and paternalistic and needs to be deregulated—an argument that ostensibly contradicts the reasoning underlying Kacsmaryk’s recent order that the FDA failed to adequately assess the safety of mifepristone at its approval.

Mifepristone, that has overwhelming data to support its safety, could remain available to some people in some states regardless of the outcome of this lawsuit. While the FDA approves drugs for consumer use, it does not regulate the general practice of medicine. Doctors can prescribing FDA-approved medications off-labelmeaning they can prescribe a drug at a different dose, in a different way, or for a different use than what the FDA has approved it for.

The mifepristone case has broad implications for the future of the FDA and could have devastating health implications in the US. 62% increase in life expectancy in the 20th century. These include vaccines and medications for childhood and infectious diseases such as HIV, increased regulation of tobacco, and over-the-counter Narcan to combat the opioid crisis.

The FDA must be able to use its scientific expertise to make data-driven decisions that balance safety and access, without the ability of a single judge to potentially undermine the system. The agency’s history is an important reminder of the need for strong administrative bodies and constant vigilance to protect everyone’s health.

Merry C. Vega is a highly respected and accomplished news author. She began her career as a journalist, covering local news for a small-town newspaper. She quickly gained a reputation for her thorough reporting and ability to uncover the truth.

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