'Round the Sphere: PDUFA, DTC and Pet Turtles Too!

The Food and Drug Administration Revitalization Act (S.1082) has been approved by Congress (see "Congress Expands FDA's Oversight On Drug Safety") and will soon be signed into law (you can read the entire bill here).

While Ed Silverman over at Pharmalot makes a big deal out the intense lobbying by advertising agencies and broadcasters to make sure the bill had no restrictions on DTC (see "Why Tougher DTC Restrictions Were Killed"), he overlooked the murky-water lobbyists who worked hard to ensure there were also no restrictions on the marketing and sales of pet turtles.

I refer, of course, to Title VII of the bill, which states that the FDA is prohibited from restricting the sale of turtles less than 10.2 centimeters in diameter.

The pet turtle industry feared a "turtle moratorium," however the Pet Turtle Advertising Council of America (PTACA) lobbied hard and long to have Title VII inserted into the bill. It would have been unseemly for turtle farmers, wholesalers, or other commercial retail sellers of pet turtles to do so directly.

For more on that, see "DTC Here to Stay; Pet Turtles Too!" over at Pharma Marketing Blog.

The WSJ Health Blog also covered this story (about the DTC advertisers' lobby, not the pet turtle lobby) -- see "Advertising Allies Turn Tide for Pharma."

PhRMA -- the US drug industry trade association -- was ecstatic about the bill's provision regarding the preview of broadcast TV ads, but was mysteriously silent about the turtles:

"...the legislation will enable FDA to hire additional employees to review broadcast drug advertisements prior to public dissemination, helping to ensure that benefits and risks are clearly and accurately communicated. It also will create strong incentives for companies to submit such advertisements to the agency before airing them, in accordance with PhRMA's Guiding Principles on Direct-to-Consumer Advertisements about Prescription Drugs." (See "PhRMA Statement on Congressional Passage of PDUFA".)

NRx, of course, had more pressing news to report: ie, "Getting high on a can of Coke."

Hundreds of people every year are poisoned by pet turtles and we're talking about getting high from Coke?!!! Something's not right.

Finally, Mark Senak over at Eye On FDA, began his post ominously:

"As we all wait anxiously for Congress to do its job and actually produce legislation for signature, and as many FDA employees see their jobs hanging in the balance while awaiting PDUFA IV, some may wonder what it is all about and what is at stake."

Clearly, Mark is more worried about those poor FDA employees -- whom I calculate will be paid $231,481.48 per year to preview TV DTC ads (see my math here) -- than about those pet turtle owners who might have been denied licking the backs of their reptiles to get high!