New limits on cold medicine are nothing to sneeze at – but why don’t they go further?
I’ve come down pretty hard on the FDA for sitting on their hands and refusing to act on the issue of over-the-counter cold medicines for kids. But I was wrong well, I was wrong for the wrong reasons. Earlier this month, drug makers stunned the medical community by announcing (finally) that they will no longer recommend OTC cough and cold medicines for children under 4 years old.
But it turns out that Big Pharma didn’t renounce their stance on OTC cold meds for kids out of the goodness of their hearts. They did it because they FDA coaxed them into doing it.
That’s right: the FDA did the right thing, sort of. But the FDA’s not entirely perfect here. They allowed the drug makers to use the age of four as the threshold for OTC cough and cold medicines rather than age six, which was the age recommended by many pediatricians.
Apparently, the FDA had been in discussions with officials from the pharmaceutical industry, encouraging them to make this move for almost a year. But when the drug makers made the announcement, they made it seems as though the move was voluntary.
Why?
Baltimore Health Commissioner Dr. Joshua Sharfstein says it’s because there’s often “a delicate dance between how much legal authority the FDA has, and their use of the bully pulpit for getting some sort of compromise.”
What troubles me is the word “compromise.” If the FDA’s charge is to oversee and protect the American public from foods and drugs that are unsafe, then explain to me why they need to compromise at all? Especially on something as easily proven as the ineffectiveness and potential danger of giving OTC cough and cold medicines to children younger than 6 years old?
Mind you, there’s been an outcry against the use of these medicines for kids from large numbers of pediatricians. And the FDA had even acknowledged during public hearings that it was concerned about the lack of solid evidence that supports the use of these OTC medicines for children between two to 6 years old. Not long ago I wrote to you about a CDC study that said the use of OTC cough and cold meds sends as many as 7,000 kids a year to hospital emergency rooms.
Compromise? How could setting a safe age parameter for these medicines be outside the legal authority of the FDA? And how, exactly, did the FDA arrive at the “under age four” cutoff when pediatricians had pushed for age six?
According to the FDA, it’s because most of the hospital data that they were working from (and which was, the FDA claims, the subject of a long internal debate) involved children under the age of four. And yet – suspiciously, if you ask me – the FDA refused to release the hospital data, which was at the core of this debate, and that helped them to reach this decision.
A few of the FDA’s independent advisors on the topic of OTC cold medicines for kids believe that even 6 years old is far too young for these drugs. “There was no data suggesting that the drugs were effective in kids under 12,” said University of Pennsylvania professor of epidemiology and biostatistics Sean Hennessy.
Where’s the logic? Pediatricians push for a ban. That ban is supported by the FDA’s very own advisers. And yet the FDA finds itself compromising with Big Pharma to get a downgraded recommendation finally “approved” by the drug companies and then drug companies act as though the change in usage recommendations was their idea.
