Monday, July 28, 2008

Is this any way to run a regulatory agency?

The Associated Press recently featured a story on my subject for today which began as follows: "When a state trooper pulls over a speeding motorist, the officer usually writes out a ticket on the spot."

However, when federal regulators catch a pharmaceutical company marketing prescription medications for an "unapproved" use, it typically takes the U.S. FatalFood and Drug Administration (FDA) an average of 7 months to even issue a warning, and then it typically takes another 4 months for the company to fix the problem.

Last year, the FDA took an average of 6 months to issue regulatory letters citing Direct-to-Consumer (DTC) marketing violations, according to Marcia Crosse, who heads the GAO's healthcare division, testifying before a House subcommittee recently. In one case, the agency took more than 3 years to issue a regulatory letter, FDAnews reported. Before 2002, when the FDA decided that all draft warning or untitled letters had to undergo legal review (a policy for which there was no apparent need) it took less than a month to send such letters, Crosse told the committee.

In other words, problems of this type aren't usually resolved for almost a year after being discovered!

No wonder the drug industry has no fear of regulators -- even when the rules ARE enforced, the companies can collect millions in drug sales before they even have to fix the issue! It's often more profitable to do nothing and then delay paying any fines. Just imagine if an automobile speeding ticket was only a warning and it was sent to you 7 months after the violation. Now consider IF you even had a fine to pay, but you could then take another 4 months before you had to pay it. Logic suggests no one would even fear being pulled over in such circumstances, which is just the situation we have with the drug industry today.

The report was done by the the U.S. Government Accountability Office (GAO), and examines DTC marketing, but also addresses "off-label" prescribing. Off-label prescribing is sometimes seen as a gray area of medical practice and federal oversight, specifically the use of medications to treat conditions other than the ones the drugs were approved for. There have been widespread abuses reported, particularly in the area of marketing antidepressants.

Doctors, of course, can make off-label prescribing decisions on their own, but drug manufacturers are (at least presently) explicitly prohibited from marketing drugs for uses other than those specifically approved by the FDA. However, as I reported back in February, the FDA was considering broadening the marketing of drugs beyond what the drug has already been approved for. Critics cried foul, claiming the move would benefit no one other than drug makers. The final guidance on that proposal has not yet been released.

The GAO report also noted "In addition, FDA's issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs."

Even more troubling was the fact that a mere 2 (that's right, TWO) regulatory letters were issued in 2007 compared with as many as 25 letters each year between 1997 and 2001, before the legal review policy. Meanwhile, the FDA "has received a steadily increasing number of advertising materials directed to consumers," according to the GAO report, which tallied about 6,000 in 1999 and 21,000 last year, again according to FDAnews.

Sen. Charles E. Grassley, an Iowa Senator who fears that federal programs such as Medicare and Medicaid are being forced to pay billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20% of prescriptions written in the U.S. are for off-label use.

Grassley requested the review by the investigative arm of Congress (the GAO) and discovered that the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. Apparently, the FDA does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses. That office has 44 full-time employees assigned to review ALL drug advertising, including television and magazine ads. Last year, that particular office had to dissect the fine print on about 68,000 advertisements. One can only wonder whether the big hiring spree now going on at the FDA will increase the staff in this department, or whether the money will go to more "retention bonuses" for ineffective bureaucrats (see my diatribe on that subject here)?

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