A More Vigilant FDA

The latest data from FDA shows warning letters on drug promotion almost doubled in 2009 to 41 from 21 in 2008. That is not surprising given the changes in Washington. Clearly the Democrats are demanding more enforcement actions against drug companies, which they saw as lax under Bush.

FDA has indeed speeded up its process to issue warning letters. The new head of FDA Dr. Margaret Hamburg has pledged to step up enforcement. Most of the letters are for inadequate fair balance. Obviously, there is always a desire from drug companies and advertising agencies to stress the positive. No one wants ad space dedicated to stressing negative points. The law, however, requires balance and some drug ads were non-compliant.

No one can argue against a vigilant FDA. The public needs it and drug companies are better off if violators get caught. The more warnings issued the more likely Congress will realize that the FDA is vetting drug ads, thoroughly and quickly warning offenders to end their campaigns. Companies who fully comply expect FDA not to let their competitors get away with unfair balance.

What FDA needs to do is continue to issue guidances and educate drug companies with examples of acceptable and unacceptable treatments of fair balance. As long as FDA is consistent and clear in what is violative the drug companies will have no problem complying. It is clear that most new drugs are using DTC in their launch campaigns. Therefore the guidances on what is acceptable treatment of risk are critical to brand teams developing DTC. No drug company wants a warning letter and its possible consequences and I believe they do want to comply. In the past there have been inconsistent decisions as to what is a violation. I hope the FDA reviewers are huddling with each other to ensure standards for one category are the same as others.

So go to it FDA, and if warnings increase in 2010 from 41 to 81 so be it. All the industry can ask is for clear standards, fast pre-clearance and sensible negotiation over disagreements on what is fair balance. That requires continued quantitative studies as to what consumers take away from drug ads so we all know what is fair disclosure. It is not in the public interest to overwhelm consumers with information as studies have shown less can be more in terms of risks and warnings. Drug companies have a right to sell their products through DTC and it is in everyone’s interest to have a well staffed FDA overseeing it.