The Government Accountability Office’s new report on DTC states the obvious -- the FDA lacks an effective way to screen, review and track pharmaceutical advertising.
Considering that more than 10,000 ads and Web sites are brought to the agency's attention each year, that DDMAC has but six reviewers, and that the PhRMA DTC guidelines recommend that ALL advertising be submitted for review – makes us underwhelmed by the GAO’s prescience and wisdom.
Once again drugwonks says, “show me the money.â€
In a draft of a letter to be sent today to the White House, Senator Herb Kohl, D-Wis., asks President Bush to give the FDA more money to review and regulate direct-to-consumer ads. Kohl, along with Republican Sens. Bill Frist of Tennessee and Charles Grassley of Iowa, requested the GAO report.
''If we are serious about protecting the health of consumers in our country, then we need an FDA capable of reviewing ads and taking swift action when necessary. This report tells us that were nowhere close to that goal,'' said Kohl, who will become chairman of the Senate panel with jurisdiction over the FDA budget.
Hello PDUFA!
Letter Imperfect
On the same topic, the GAO report comments that the FDA is sending out fewer DTC-related NOVs.
Indeed, Waxman Redux.
But the truth is that you can’t count letters and say that enforcement is better or worse. It may just as well be the case that pharmaceutical companies are being more compliant (in a regulatory sense) – as could easily be predicted since the FDA has been more precise in detailing (you should excuse the expression) what “in compliance†means. Not precise enough – but better than before.
GAO also reports that the FDA is taking longer to send out letters. This issue is more complicated, but the bottom line is that sending out poorly lawyered letters more swiftly is a fool’s errand.
Unfortunately, there are a lot of fools out there. Fools on the Hill.
Considering that more than 10,000 ads and Web sites are brought to the agency's attention each year, that DDMAC has but six reviewers, and that the PhRMA DTC guidelines recommend that ALL advertising be submitted for review – makes us underwhelmed by the GAO’s prescience and wisdom.
Once again drugwonks says, “show me the money.â€
In a draft of a letter to be sent today to the White House, Senator Herb Kohl, D-Wis., asks President Bush to give the FDA more money to review and regulate direct-to-consumer ads. Kohl, along with Republican Sens. Bill Frist of Tennessee and Charles Grassley of Iowa, requested the GAO report.
''If we are serious about protecting the health of consumers in our country, then we need an FDA capable of reviewing ads and taking swift action when necessary. This report tells us that were nowhere close to that goal,'' said Kohl, who will become chairman of the Senate panel with jurisdiction over the FDA budget.
Hello PDUFA!
Letter Imperfect
On the same topic, the GAO report comments that the FDA is sending out fewer DTC-related NOVs.
Indeed, Waxman Redux.
But the truth is that you can’t count letters and say that enforcement is better or worse. It may just as well be the case that pharmaceutical companies are being more compliant (in a regulatory sense) – as could easily be predicted since the FDA has been more precise in detailing (you should excuse the expression) what “in compliance†means. Not precise enough – but better than before.
GAO also reports that the FDA is taking longer to send out letters. This issue is more complicated, but the bottom line is that sending out poorly lawyered letters more swiftly is a fool’s errand.
Unfortunately, there are a lot of fools out there. Fools on the Hill.
