Why It Took So Long for the FDA to Tackle a Cold Medicine

Dr. Leslie Hendeles began prodding the Food and Drug Administration to reject a decongestant in cold medicines when he had a mop of curly red hair and Bill Clinton had just become president.

By the time opposition to the drug had coalesced, Dr. Hendeles was appearing, at age 80, as an expert to testify before the agency’s advisers, his hair white and his overview of the ingredient spanning 50 years.

His advocacy culminated in the advisory panel’s unanimous vote on Tuesday, when it concluded that the decongestant, a common ingredient in cold and flu remedies, is ineffective.

Prompted by the news, consumers threw open their medicine cabinets upon learning that the decongestant, phenylephrine, was listed in more than 250 of their go-to drugs for congestion like some versions of DayQuil, Sudafed, Tylenol and Theraflu. And the decision has caused some confusion — experts say the ingredient still works in nasal sprays, just not when taken orally in pill or liquid form.

One could argue the process of dissecting phenylephrine — a drug used for dilating eyes and calming hemorrhoids — took roughly six decades. The Kennedy era had ushered in a new law that required the F.D.A. to evaluate a drug’s effectiveness in addition to existing safety standards.

It wasn’t until 1976 that the F.D.A. began reviews of over-the-counter cold medicines, like phenylephrine, as a class of drugs.

But by the early 1990s, the decongestant still hadn’t received a full approval, and the lengthy delays had attracted the attention of Dr. Hendeles and a group of pharmacy professors at the University of Florida.

They would become the one constant in the last 30 years of phenylephrine’s history by putting pressure on the F.D.A. to do something.

As their research progressed, Dr. Hendeles tried to reach the F.D.A., where he had once been a visiting scientist. He was not breaking through, he said. So he turned to the office of U.S. Representative Henry Waxman, a crusading California lawmaker, for help.

“It was a joy to read,” Dr. Hendeles said.

When he testified before the panel earlier this week, Dr. Hendeles talked about a study from 1971 involving modified scuba masks to measure nasal congestion — the first finding phenylephrine to be a dud.

Other organizations including Public Citizen, the American College of Clinical Pharmacy and the National Center for Health Research also urged the panel to dispense with the ingredient. The industry association argued that the ingredient was effective and that low levels in the blood did not negate its effect. A statement from Kenvue, a spinoff of Johnson & Johnson, said products with phenylephrine are a small part of its business and it sells cold products without it.

When agency advisers cast their 16-to-0 vote, Dr. Hendeles was thrilled. “Nothing was as exciting and exhilarating as the vote,” he said.

Lawyers representing people who purchased cold and flu medicines containing phenylephrine are already announcing lawsuits against the drug makers, claiming the companies knew the decongestant was useless.

For now, the products remain on the shelves. “We feel vindicated for something that we worked on for a long time,” Dr. Hatton said. “But it’s not over.”

Sahred From Source link Health

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