“The recent court decisions could erode the F.D.A. approval process — put in place to protect the public — and threaten public health and patient safety,” warns Dr. Margaret Hamburg, until recently the Food and Drug Administration’s commissioner.

Experts on mental health fear that these rulings could lead to “terrible trouble by confounding science with marketing,” says Dr. Steven E. Hyman, a Harvard expert on psychiatry and former director of the National Institute of Mental Health.

Already, 80 percent of the psychiatric medicine administered to children is “off label,” Francesco estimates, meaning that the F.D.A. hasn’t approved its use for that purpose. Sometimes, off-label use makes sense, but it must be done with care, not just as a result of aggressive marketing by pharmaceutical companies simply aiming to boost quarterly profits.

“Children, because their brains are still developing, are not just small adults,” Hyman notes.

The pharmaceutical industry repeatedly has shown why “regulation” shouldn’t be a dirty word in American politics:

■ In the early 1960s, many countries allowed the “wonder drug” thalidomide to treat morning sickness in pregnant women. A heroic female doctor at the F.D.A., Frances Kelsey, resisted industry pressure to approve thalidomide in the United States, thus averting thousands of horrific birth defects like those it caused abroad.

■ In the mid-1990s, pharmaceutical companies argued that doctors systematically under-treated pain, and as a solution the manufacturers aggressively marketed opioids. The companies’ behavior was sometimes criminal (executives of the company that made OxyContin pleaded guilty to criminal charges), but also hugely profitable. This helped lead to a crisis of addiction to prescription painkillers and heroin; today, drug overdoses kill more Americans than guns or cars do.

■ In a recent column, I recounted how Johnson & Johnson deceptively marketed an antipsychotic medicine called Risperdal, concealing for example the fact that it can cause boys to grow large, pendulous breasts (one boy developed a 46DD bust). J&J got caught, pleaded guilty and paid more than $2 billion in penalties and settlements — but also registered $30 billion in Risperdal sales. The executive who oversaw this illegal marketing effort was Alex Gorsky, who then was promoted to chief executive of J&J. If you’re a pharmaceutical company, crime sometimes pays.