In the Out Door
The FDA just threw open the wrong door.
Late last year, FDA officials floated an idea that would ease government bureaucracy (good idea!) and put consumer safety in jeopardy (really bad idea!).
The FDA allows doctors to prescribe any drug to treat any health condition – this is “off label” prescribing. The catch: Drug companies can only promote a drug for the condition it’s been approved for by the FDA. This prevents drug company sales representatives from pressing doctors to prescribe a drug for unapproved uses.
As you can imagine, drug company executives don’t like that restriction one bit.
So this past December, the FDA issued a nonbinding “draft guidance” that would allow drug reps to give doctors published articles that support non-approved uses for drugs.
Congressman Henry Waxman neatly summed up this “guidance,” noting that it “would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs.”
So what did FDA officials do? They completely ignored Representative Waxman and stepped up to the next level, recently issuing proposed guidelines for this plan that’s little more than a big beautiful gift to drug companies.
A fine mess
So what’s the big deal? Let’s say the New England Journal of Medicine publishes evidence that osteoporosis risk is decreased when Lipitor is applied directly to the forehead. Shouldn’t sales reps for Pfizer (the maker of Lipitor) be able to give copies of that article to doctors?
Actually, congress already agreed to this practice in the late 90s when a law was passed allowing drug reps to share articles with doctors.
But back then there were two conditions: 1) Copies of the articles had to be submitted to the FDA, and 2) A drug company that submitted an article had to promise to begin the process of seeking FDA approval for the off-label use of the drug.
That first condition? No problem. Pop a photocopy in the mail and you’re all set. But the second condition was just a HUGE pain. Drug companies had to mount at least one study (there goes a few hundred thousand bucks right there), and if the study didn’t produce conclusive results or if the side effects were too debilitating, then you had to suppress the results, mount ANOTHER study (get out the checkbook AGAIN), and if THAT study didn’t go wellwhat a mess!
Play it again, Harry
That previous law lapsed a couple of years ago, and since then the issue about sharing articles has been in limbo. So the new draft guidance seeks to establish clear guidelines, AND (bonus!) those two annoying requirements have been dropped. No more bothering with sending copies of articles to the FDA, and no more promises to mount studies to examine little details like efficacy and safety.
And do you know why it makes no difference at all for FDA officials to drop those prior requirements? According to a New York Times report, one FDA representative confides that “the agency did not really enforce those requirements anyway.”
Seriously! It’s as if the FDA is saying, “Who’s fooling who? We can’t keep up with you guys. Go ahead and push those articles.”
But this time there are two NEW conditions placed on drug companies. 1) Only articles that have been peer-reviewed can be given to doctors, and 2) Each article has to have a “prominent warning” that the use described in the article has not been approved by the FDA.
Wow! A prominent warning! In other words, this is a completely toothless reworking of a scheme that had very little bite to begin with.
So – again – what’s the big deal? So what if drug reps show journal articles to doctors? Doctors might come across those articles anyway, right?
Well, here’s what makes it a big deal. As everyone involved with this dance is aware of – doctors, sales reps, journal editors, congressmen, everyone – you just can’t trust everything you read.
In the e-Alert “How Much is that Doctor in the Window?” (8/11/03), I told you about a New York Times report that detailed a criminal and civil investigation of a drug company. Court documents showed that company officials hired a marketing firm to write medical journal articles that placed their drug in a positive light. The company paid $12,000 for each article and an additional $1,000 to various doctors who agreed to allow their names to be listed as “authors.” Salespeople then distributed the phony articles to doctors to persuade them that the drug was safe and effective for off-label use.
Congressman Waxman? Play it again, please, and tell us one more time what you believe the proposed FDA guidelines will do:
- Open the door to abusive marketing practices
- Jeopardize safety
- Undermine public health
- Lead to an increase in unapproved uses of powerful drugs
Source:
“F.D.A. Seeks to Broaden Range of Use for Drugs” Gardiner Harris, The New York Times, 2/16/08, nytimes.com
