The latest from DTC Perspectives

FDA and DTC

There are some critics who hope serious restrictions will be placed on DTC advertising in 2009. These anti-DTC folks include some politicians, consumer advocates, medical professionals, and insurance plans. My guess is they will be disappointed with the slow pace of increased regulation.

Our Congress will take up health care later this year. Extending health coverage and cost containment will be the big issues. We have an enormous cost bubble which will burst unless serious action is taken within the next decade. Drug costs are part of the issue, but given slower rates of drug inflation versus other health costs, it is not the top priority.

We will see action taken short term to put more pressure on drug prices. That includes re-importation and Medicare price negotiation. That should result in drug prices being held down significantly. The DTC specific issues are also important to Congress. Clearly they would prefer it could be legislated away because they believe it causes improper branded drug use and thus raises costs. They also say safety is an issue and want drug advertising delayed for new products until a full in-market safety profile is known. They also know they cannot just ban legal commercial speech so the ban is off the table. The best they can do is place a moratorium on new drug ads and make television ads harder to execute.

If the pace of DDMAC research on DTC is any indication we can expect a slow and measured consideration of change. Their web site lists the upcoming DTC study research dates and it appears much of it will not be out until 2012. Their small staff and budget prevents them from acting faster. Congress blusters a lot about action but then provides miniscule resources to get things done.

Obama says health care action is too important to wait. He is right but the health care issues make banking problems seem simple. The massive administrative bureaucracies both in Medicare and the private insurance sector will take years to change. All the good intent in the world will not make major change happen soon. I would say DTC regulation is way down on the list of changes needed.

What then can we expect for DTC? Probably not much new DTC regulatory action will happen in 2009 or 2010. There is no major problem with DTC being an imminent threat to safety or raising drug cost. FDA will be more active in issuing warning letters and demanding corrective ads.  That should satisfy the increasingly regulatory minded Congress for the next few years.