Company Z makes widgets. The widgets are highly regulated by the government, so much so that any time the company wants to produce a new kind of widget, it must get explicit government approval to do so. It must show all of its widgets are safe.
The government grants its approval, Company Z sells millions of widgets, and some of the widgets end up hurting people. The people decide to sue over their hurt.
But then Company Z throws them a curve ball — you can’t sue, since the government already declared our widgets safe! If they weren’t safe, the government wouldn’t have approved them in the first place.
Welcome to the U.S. Food and Drug Administration regulatory system, which is now under scrutiny in a number of legal cases winding their respective ways through different court systems.
This legal argument is called pre-emption. After decades of being dismissed by courts, the tactic now appears to be on the verge of success, lawyers for plaintiffs and drug companies say.
The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.
Isn’t that exactly what courts are meant to do, however? Act as a balance to our lawmakers and executive branch, to ensure that everyday citizens’ rights aren’t trampled by pharmaceutical special interests and huge lobbyist groups?
The core problem is that the FDA is a mess and broken. It makes many of its decisions knowing full well that they are not always in the best interests of U.S. citizens, but rather expediency — the simplest course is best. I think they make exceptions to this rule, when enough people’s lives are potentially in danger. But time and time again, we see inaction the rule when it comes to the FDA — if it ain’t “broke,” don’t fix it.
And the longer they put off fixing any particular issue that crops up with a drug, the more money the drug company makes. It may not be intended to work that way, but that’s how it is. Drug companies realize this, so also drag their heels whenever possible, since the minute the FDA makes a decision about its drug, it could tank sales:
The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.
[…] “Johnson & Johnson knew that F.D.A. does not have the funding or the manpower to police drug companies,” [a plaintiff’s lawyer] said.
Which is born out by the testimony of ex-FDA workers and scientists, like Dr. John Gueriguian. He “testified that the agency did not always ask for strong warnings even if it believed a drug was risky. Companies typically oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Dr. Gueriguian said.”
“We at the F.D.A. know what we can obtain and we cannot obtain,” Dr. Gueriguian said. “We have many, many problems, and we have a management system — what we can’t obtain we will not ask.”
In other words, in a sensitive bureaucracy like the FDA which is a minefield of balancing acts, you have to carefully pick your battles. Even if it means some people may get harmed due to not having all the information they should have.
This case is more complicated than I can go into here, so I highly recommend reading the full New York Times article (below).
I just wanted to focus on the point that any government agency tasked with both regulation and policing of an industry is going to be ineffective. For instance, the F.A.A. is in the same position — to advocate on behalf of the airline interests in government and regulate such interests, but then to also police the regulations and ensure airlines do what they agree and say they will do. It’s a role with an inherent conflict of interest which causes all sorts of problems.
If Congress wants to fix the FDA, the only way to do so is to break it into two distinct agencies, one for approval of new drugs, and one for policing of the drug regulations and followup on longer-term drug safety and efficacy.
It’s a painful pill to swallow, but it’s not going to get any easier the longer we wait.
Read the full article: Drug Makers Near Old Goal: A Legal Shield