The FDA and You

You might be shocked to hear that the Superintendent of the Montgomery County schools has a budget akin to what FDA Commissioner von Eschenbach has to run an agency that regulates a whopping 25% of American consumer spending. Think about how you use FDA-regulated products each day -- when shampooing, brushing our teeth, taking aspirin or prescription drugs, applying makeup, putting on sunscreen, talking on a cell phone, cooking food in a microwave, and even watching TV. It starts to seem like there is little in our daily lives that isn't affected.

In recent weeks, I've been participating in hill visits with the FDA Alliance (I also sit on their Board) to talk to Congressional staff about FDA's resources. We've been making headway to increase awareness about the need for increased appropriations for FDA. We have yet to meet with anyone who disagrees with the argument that the agency needs more money. How much of an increase we'll see remains to be seen, but the next few weeks will be critical.

The FDA budget has been going backwards not forwards because of inflation, increasing costs, expanded missions, and scientific advancement. The current budget levels are far from adequate. We're asking for $2 billion for fiscal year 2008 (plus user fees on top of that).

I think we'd all agree we look to the FDA to be at the ready as scientific innovation flows through the pipeline. Otherwise what's the point of investing in innovation in the first place? We're expecting cures, and we'd like them sooner than later. The agency needs to be a cutting-edge regulator, one that is a "Gold Standard" worldwide. We need to be maximizing the potential of things like large datasets of electronic health records. This will aid in monitoring drug safety.

The list of things that FDA staff are thinking about now is no doubt long, but they can't scratch the surface without adequate funding. We are all either patients now, or will be one at some point. We need a strong and robust FDA. The 111 members of the FDA Alliance representing consumers, patients, professional societies, and industry all uniformly agree on that point. Increasing FDA's budget is a win-win for public health and the economy. Wouldn't you agree?

Margaret Anderson, COO, FasterCures

Working For You?

I had all of 4 minutes on CNBC this week – which I shared with Merrill Goozner -- to answer the question, “Should the FDA be speeding cancer drugs to market?” What a question.

Answer: YES -- if they work, NO -- if they don’t! (Merrill agreed. that left 3 minutes of dead space.)

But there’s the rub. What does it mean for a drug to “work?” Is extending life three months at a cost of ten to twenty thousand dollars per patient “working?” Is a drug that has a 92% chance of not being a placebo effect “working” compared to a drug that has a 95% chance?

This issue came to a head at the recent meeting of the American Society of Clinical Oncologists – otherwise known as “cancer doctors.” According to the New York Times, several people who had spoken out against a particular cancer drug received threats, even death threats. Apparently some patients felt they had the right to have this drug approved as a last resort even if many scientists felt it did not “work.” And if those scientists didn’t support “saving their lives”, these angry patients felt comfortable threatening them. This is an example of a system that is not working.

Or rather, the system is working just as we set it up to work. We have a $100 billion research enterprise feeding products into a $1 billion drug review system, funded to an ever growing degree by industry user fees. At the front end, we have some pretty strict rules for what constitutes “working.” And anything less than a high “non-randomness” score (i.e. 95% chance of not being random) won’t “work.” Try telling that to terminally ill patients who want to take a drug that has a score of 90 or 85.

Meanwhile, those user fees have been restricted for years from being applied to post market surveillance of newly approved drugs. If you can’t do post market surveillance, you don’t know how a drug is working in the real world until someone reviews random adverse event reports from doctors and starts comparing them to previously obtained clinical trial data that may or may not have tested for the reported effect. And then when deadly effects are discovered in some people, all hell breaks loose because nobody was monitoring whether the drug “worked.”

Avandia. Vioxx. Accutane. Thalidomide. All these drugs work for some people in some very important ways. For other people, they don’t just not work, they’re deadly. Until we have a system that works, it will be hard to tell whether the drugs are working ….or wasting both money …and lives.

Greg