QDIS Blog

Is the FDA More Cautious Now?

by Ed Vawter @ 1:23 pm. Filed under FDA, Drug Development

A recent article in the New York Times reports that the FDA may be more cautious in the after-math of Vioxx. I call this the Vioxx Effect.

New Sense of Caution at F.D.A. - New York Times

The article point to Avastin as an example where the FDA has asked for more data related to Genetech’s filing of the use of this drug in breast cancer. It is already approved for colon cancer. They also point to other drugs that have been approved in Europe but only have received an approvable letter here in the US. An approvable letter means the FDA would approve the drug if additional data is provided and the data supports the conclusions.

This is in contrast to the Institute of Medicine report that found the FDA is not doing its job adequately. So how can these both be true? I think a lot has to do with what material was looked at and how it was interrupted. I think both are correct. The FDA does need some changes and most importantly an increase in funding to adequately do its job. The recent food incidents of lettuce and spinach point to the lack of oversight in the food arena.

FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach Update: Sunday, September 17, 2006
US FDA/CFSAN - Lettuce Safety Initiative

I do think though that the New York Times and Wall St. tend to focus more on the profitability and money side of things and ignore safety issues. I also think that some of the incidents of the drug industry not being more transparent has led to the overall reputation of both the industry and the FDA. As an example, Bayer recently failed to inform the FDA of data related to dangers with a heart surgery drug, Trasylol. It seems the company wanted to delay reporting these results until they could come up with other results to discount the negative study.

Bayer’s Duplicity on Drug Safety - New York Times

These sorts of incidents only play into the already widespread belief in the general public of the pharmaceutical industry being greedy and not having the best interest of patients at heart. This is an area where I truly believe reform is needed. Public disclosure of ALL studies and not selected studies should be required and there should be a centralized database for this that is accessible on the Internet.

So, both sides have valid point but here are the areas I think are in most need of reform.

1. Food Inspection: the FDA needs to be more proactive in the food area as evidenced by recent outbreaks of e. coli in spinach and lettuce.

2. Database to report publicly all studies preformed on a given drug. It should be required to be done in a timely fashion.

3. FDA needs the power to fine companies for violations. Currently there only have the power to pull a drug off the market. I’ve always thought it was strange and unreasonable that the FDA did not have this power. The EPA has this power and has been using it effectively for many years.

While I believe some reform is needed, I think it should be approached cautiously and without political ends in mind. If these areas are addressed, I think the FDA can bemuse a respected agency again in the near future.

Technorati Tags: FDA, FDA enforcement, food safety, Vioxx effect