Dec. 21, 2006
A couple of FDA items in the news yesterday are of interest, as is an oped about dealing with drug costs. First, the Washington Post reports on a new Government Accountability Office (GAO) study that new drugs are decreasing while the cost of drug R&D is increasing. In fact, the cost of R&D for drugs has increased to $60 billion annually from 1993 to 2004.
The amount of regulation on drug companies is definitely part of the reason for the enormous costs of getting new drugs to the market. I had a friend working for a company, and her job was to help companies run clinical trials in line with FDA regs. After a trial was complete, she said the amount of paperwork literally filled two trucks (not pickup trucks either). The amount of paper work alone has got to drive up costs, which of course are passed on to the consumer.
Second, it was widely reported yesterday that the FDA will require clearer labels for over-the-counter pain meds. I was shocked at how many deaths are attributed to pain killers (Tylenol, Aleve, etc). According to a Washington Post article:
Acetaminophen [Tylenol] sends an estimated 56,000 people to the emergency room each year, the FDA said. About 100 people die each year after unintentionally overdosing on the drug. Ibuprofen is sold under the brand names Advil and Motrin and in generic form. Naproxen is best known as Aleve but is also sold generically. The NSAIDs are blamed for sending more than 200,000 Americans to the hospital every year and are linked to an estimated 16,000 deaths, the FDA said.
Third, there's an interesting oped "Freeing the Drug Market" in yesterday's National Review online. David Gratzer calls for the removal of FDA's "efficacy" standards, not "safety" standards. (Remember, the FDA is to ensure drugs are "safe and effective.") He makes some good points about over-regulation, drug R&D costs, etc. If I understand correctly, his main argument is that FDA's testing for "efficacy" of a drug (not just "safety") is always different than real-world "efficacy," because doctors use drugs off-label. So, Gratzer argues we should just get rid of the FDA's efficacy requirement, which would reduce regulations and thereby reduce drug costs without risking "safety." I think it's an interesting idea. Of course, one could easily argue, instead, that we should restrict off-label use. I'm not sure either option would work at reducing costs....but I do think that restricting "off-label" use would be a disaster for our "free market" health system. It would mean that physicians would not be the primary caretakers, but rather those in Washington.
According to the WaPo article on the GAO drug R&D costs study, Rep. Henry Waxman (D-CA) and Senators Richard Durbin (D-IL) and Ted Kennedy (D-Mass) requested the study, and now they want to "reexamine" the drug development system. We'll see what the new Congress decides to do.