Former New England Journal of Medicine editor Marcia Angell had an editorial in the Boston Globe last week that should not be missed. Excerpts:
"It's time to take the Food and Drug Administration back from the drug companies. … (I)n 1992, Congress put the fox in the chicken coop. It passed the Prescription Drug User Fee Act, which authorizes drug companies to pay "user fees" to the FDA for each brand-name drug considered for approval. Nearly all of the money generated by these fees has been earmarked to speed up the approval process.
In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster.
But while it's a small investment for drug companies, it's a lot of money for the agency, and it has drastically changed the way it operates -- creating a disproportionate emphasis on approving brand-name drugs in a hurry. Consequently, the part of the agency that reviews new drugs gets more than half its money from user fees, and it has grown rapidly. Meanwhile, the parts that monitor safety, ensure manufacturing standards, and check ads for accuracy have languished or even shrunk. …
As part of the emphasis on speed, the FDA often approves brand-name drugs on the basis of less evidence than in the past. In these cases, approval may be contingent on companies conducting further safety studies after the drugs are on the market. But the companies usually don't honor that commitment. Of the roughly 1,200 such studies outstanding -- some for years -- over 70 percent haven't been started. …
The FDA now behaves as though the pharmaceutical industry is its user, not the public. Fortunately, the user fee law is subject to renewal every five years, and this is one of those years.
Congress should let the law die this time around and substitute its own support -- which ought to be increased. Other reforms recently proposed, such as administratively separating drug approval from safety surveillance, will not mean much as long as this law is in effect.
At $300 million to $400 million a year, the equivalent of about a day in Iraq, Congress can easily afford to buy this vital agency back for the public, and it should."