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).
Two provisions — or lack thereof — of this law stood out to me: (1) a one- or two-year moratorium on direct-to-consumer (DTC) ads for all new drugs did not make it into the bill, and (2) a provision prohibiting the FDA from restricting the sale of turtles less than 10.2 centimeters in diameter as a pet DID make it into the bill (Title VII – Domestic Pet Turtle Market Access; Section 703).
I am not a pet turtle safety expert, but I learned from a quick blog search (here) that pet turtles can poison you!
Who am I to question how or why the turtle provision made it into a drug safety bill? It’s been rumored, however, that 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 (see here).
But enough about the nation’s emerging pet turtle safety problem. Let’s focus on DTC and what new powers over DTC S.1082 gives to the FDA.
It’s Mostly About the Money
Firstly, FDA gets new fees for reviewing DTC ads before they are aired on TV. See “PDUFA Payola!” for more about that. According to the S.1082: “There are authorized to be appropriated for fees under this section not less than $6,250,000 for each of fiscal years 2008, 2009, 2010, 2011, and 2012…”
In a previous post (“Where’s DDMAC’s Head At?“) I showed a chart of the number of DTC materials submitted to the FDA each year. In 2005 about 4,600 print and TV DTC pieces were submitted for review. Maybe 2,000 were TV-related. If FDA gets more money to review TV ads, this could increase to 3,000. The fee per piece (eg., storyboard for one ad) works out to about $2,000. This seems like a lot of money to review a single piece. I could do it for $1,000! If FDA were to hire me, therefore, it could pocket about $1,000 for every ad it previewed.
According to an Advertising Age article, “the legislation’s main effect is to boost the number of people at the FDA who will review ads.” FDA has said that the $6+ million would be used to pay an additional 27 staffers. That works out to about $231,481.48 per person per year. Where’s the job application? I’ll sign up today.
Secondly, it’s about the fines. According to the Advertising Age article cited above, “[the legislation] also gives the FDA new authority to fine advertisers up to $250,000 a day for continuing to run any ads challenged as misleading and up to $500,000 a day for a second instance within three years.”
On first reading of the above, it would seem that the drug industry did not get what it wanted; ie, a get of jail free card for ads pre-approved by the FDA. That is, the industry wanted any pre-approved ads to be exempt from fines or warning letters after the fact.
But let’s dive deeper and actually read the legislation, which states:
“(B) Upon the request of the applicant to be assessed a civil penalty, the Secretary, in determining the amount of a civil penalty, shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors: Whether the applicant submitted the advertisement for prereview if required under section 505(o)(5)(D).”
“Subject to subparagraph (B), no applicant shall be required to pay a civil penalty under paragraph (1) if the applicant submitted the advertisement to the Secretary and disseminated such advertisement after incorporating any comment received from the Secretary.”
Therefore, the industry DID get a “Get Out of Jail Free” card after all!