prescription drugs

Did you know that the federal government has a Gastrointestinal Drugs Advisory Committee? It’s true. If you don’t believe me, you can attend their upcoming meeting on February 23. The topic of the day will be a new drug application to treat hepatic encephalopathy.

Hopefully some hepatic encephalopathy sufferers will be there. They can ask the Committee why the FDA takes as long as a decade (and as much as $800 million!) to approve medications that could be helping people and saving lives right now.

Some of the consequences of increasing government’s role in health care are easy to predict. One is that cutting costs requires cutting the amount of care. That means rationing. People judged not deserving of care would be denied it.

Another is that if government uses its increased bargaining power to lower drug prices, there will be less money for R&D. That means less innovation. That could well mean the end of increasing life expectancies.

Some people see these consequences and oppose more government in health care (I refuse to call President Obama and Congress’ proposal a reform; that word implies improvement). Others see those same consequences as reasons for supporting proposed legislation.

Today’s issue of OpinionJournal’s Political Diary (requires paid subscription) shows that Robert Reich, who supports government-run health care, realizes its effects on rationing and innovation, supports it anyway, and said so in a public speech at UC Berkeley in 2007.

Mr. Reich told the Berkeley youngsters: “You — particularly you young people, particularly you young healthy people — you’re going to have to pay more. And by the way, if you’re very old, we’re not going to give you all that technology and all those drugs for the last couple of years of your life to keep you maybe going for another couple of months. It’s too expensive . . . so we’re going to let you die’”

Reich goes on:

“I’m going to use the bargaining leverage of the federal government in terms of Medicare, Medicaid — we already have a lot of bargaining leverage — to force drug companies and insurance companies and medical suppliers to reduce their costs. What that means, less innovation and that means less new products and less new drugs on the market which means you are probably not going to live much longer than your parents.”

Whether you support more government in health care or not is up to you. But it is not disputable that those consequences exist. They should be factored into your opinion. Supporters of proposed legislation should acknowledge the effects of their ideas. Instead, they usually run away from them.

Kudos to Robert Reich for the intellectual honesty he displayed in his speech. More, please.

Today, CEI filed comments (link to PDF format) on a draft FDA guidance document advising prescription drug manufacturers on how to comply with regulations requiring the presentation of risk information in drug and medical device advertisements.  Although we disagree in principle with the current regulatory regime that requires almost encyclopedic presentation of risk information any time a manufacturer communicates the name of a drug and any mention of benefits in promotional materials, these comments focused on the FDA’s failure to treat the Internet and other new media as unique forms of communication that permit advertisers to present complete risk and benefit information in novel ways.

For example, in April, the FDA sent Notices of Violation to 14 drug manufacturers, informing them that their use of “sponsored links” to advertise prescription drugs on search engines such as Google were unlawful because the 70-character links did not present the same complete risk information required in conventional print advertisements.   But, due to constraints of the medium, sponsored links cannot accommodate all the required information, which in any event is accessible “one click” away on the landing page of the URL to which the sponsored link directs the searcher.

Ironically, the draft guidance document goes to great lengths to explain that FDA will examine the overall context of an ad’s presentation of information and the ‘net impression’ that reasonable consumers would get from an ad in order to ensure that the risk information is displayed in the appropriate way.  But, reasonable consumers don’t stop reading when they get search engine results.  Finding the landing page, where they’ll see the complete information FDA requires, is precisely what an Internet key word search is all about.  Consequently, we urged FDA reconsider this 1960s approach to drug ad regulation and bring its regime into the 21st Century.

You can read the press release here, and the entire comments document in PDF format here.