This is a new all-time low of stalling–even for the FDA

Take Your Time

I love it when the FDA does comedy.

Here’s the setup: Dr. Charles Ganley is in charge of the FDA’s Office of Nonprescription Products. A few weeks ago, Dr. Ganley wrote a letter to the Consumer Healthcare Products Association, a not-for-profit that represents OTC drug manufacturers.

Unfortunately, Dr. Ganley had some bad news. He had to inform the association that after reviewing the results of a CHPA study, his office concluded that products combining acetaminophen and diphenhydramine (a sleep aid) did not show a significant benefit as an “aid for relief of occasional sleeplessness when associated with minor aches and pains.”

So according to the study results, Tylenol PM, Excedrin PM, and any other product that combines just those two active ingredients, are no more effective than taking acetaminophen alone or diphenhydramine alone.

That’s a bit of a tough break for “PM” product manufacturers. They wanted to be able to claim an FDA stamp of approval on effectiveness. And you can’t say they haven’t been patient because after the study was submitted, they had to wait 15 YEARS for Dr. Ganley’s letter!

No kidding: It took Dr. Ganley’s office a decade and a half to review and respond to this one simple study.

That’s a new all-time low of stalling–even for the FDA.

But here’s where it gets really amusing. FDA spokesperson Shelly Burgess explained the 180-month delay to Reuters Health by pointing out the “significant workload” in regulating OTC products. She also noted that FDA officials have to prioritize, given the agency’s limited resources.

In other words, “Eh…we were busy.”

Well, you know how it is. Those years right at the end of one century and right at the beginning of another are always the busiest!

Ms. Burgess also told Reuters Health: “We need an additional study demonstrating that the combination product is more effective than acetaminophen alone and more effective than diphenhydramine alone.”

But here’s a really weird coincidence: Johnson & Johnson (the maker of Tylenol PM) just happens to have two additional studies already completed. In fact, the company submitted the results to the FDA this past March. And this time, says a J&J spokesperson, the results clearly show that acetaminophen and diphenhydramine provide more benefit in relieving pain and prompting sleep when taken together.

Interesting. The ineffective study took 15 years to see the light of day. Want to bet the results of these trials with more desirable results will get through Dr. Ganley’s office in 15 weeks?

To Your Good Health,

Jenny Thompson

Source:
“Regulators Question Nighttime Tylenol, Excedrin Data” Susan Heavey, Reuters Health, 5/5/10, reutershealth.com