PhRMA Rules Come Up Short

The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country’s leading pharmaceutical research and biotechnology companies, has sent out a trial balloon regarding its DTC Voluntary "Guiding Principles" (see "DTC Voluntary ‘Guiding Principles’ Receive Preliminary Approval by PhRMA Board of Directors").

By using a press release to reveal a few tantalizing glimpses of "areas addressed," PhRMA and its member companies, which have yet to review the guidelines, can gauge the public response and tweak the language. That's fine.

I hope they are listening.

The big item missing from the guidelines -- and I predicted back on July 5 that it would be missing (see "To Ban or Not To Ban DTC, That is the Question") -- is any talk of a ban on DTC.

The following are some of the guidelines PhRMA mentioned in its press release. PhRMA claims that these "go beyond current FDA regulations."

Conversations with physicians prior to the launch of a new direct-to-consumer campaign.

Without more details, I don't really know what this means. Does it mean that DTC ads will be delayed after launch until companies have docs take a look at them? or will they hire docs to be on focus groups duriing the development of the ad campaign?

Whatever it means, this doesn't seem too much of a hurdle. After all, there are docs out there that will do virtually anything for a buck!

For this process to have any real merit, an independent physician review board would have to be set up to approve ads BEFORE they are launched. Why not, therefore, submit ads for prior approval to the FDA who could assemble this kind of physician review like they do with other advisory committees?

This is what Bristol-Myers Squibb pledges to do (see "New DTC Principles Emerging").

The CEO of Pfizer, Hank McKinnell, in his book "A Call to Action," suggested the following DTC reform principle: "Implement external oversight of DTC, including working with the FDA to get their views on advertisements before they are run." I hope Dr. McKinnell fights to get this principle in the final PhRMA code.

TV advertisements should be targeted for audience and age appropriateness.

Hopefully, this means running ED drug ads late at night and not during family sports events.

McKinnell is also in favor of this: “No erectile dysfunction drug ads on television except for 10 pm to 6 am. I'm in favor of that.” (Washingtonpost.com Viewpoint interview, 2004).

It's also part of the BMS code.

Companies should promote health and disease awareness as part of their advertising.

They already do this, so this is not new and it does not go "beyond" current FDA regulations.

Now, if pharma companies focused on disease awareness ads instead of branded DTC, then that would be new. BMS also pledged to do exactly that.

Companies are encouraged to include information about assistance programs for the uninsured and low-income.

I have no qualms about this although it is less about a DTC principle than a promotional statement of another kind.

All in all, I think PhRMA needs to go back to the drawing board on these principles. The political winds have shifted dramatically since they started this project. Most significantly, Senator Bill Frist has called upon the industry to do more. Specifically he has called for a 2-year moratorium on DTC ads for new drugs (see "To Ban or Not To Ban DTC, That is the Question").

If the PhRMA press release offers an accurate glimpse as to what the final principles might be, then I have to say that PhRMA is woefully unprepared to lead the industry's negotiating efforts.

Remember, what Senator Frist said:

“I will be watching this issue closely. And if the pharmaceutical industry’s voluntary restrictions aren’t strong enough, I’ll support Congressional action to make sure consumers get the protection they deserve. If these voluntary restrictions don’t do the job, I believe Congress should act.”

Ok, Bill. Your move!