QDIS Blog

New FDA Drug Safety Proposals

by Ed Vawter @ 3:37 pm. Filed under FDA

Well yesterday the FDA released a report containing a lot of proposals for improving drug safety. It includes more than a dozen initiatives of various sorts but all related to drug safety.

FDA Reinforces Commitment to Drug Safety (from FDA website; just a press release)
The Future of Drug Safety — Promoting and Protecting the Health of the Public (actual report)

This report outlines the FDA’s response to the Institute of Medicine Report a few months ago and include making “report cards” on unusual side effects. Mark over at Eye on FDA has a great post about this.

This has brought up concerns about patients seeing these “report cards” and stopping taking their medications. I agree this is likely and think it has more to do with helping the general public understand risk and probability. We humans seem to have difficulty with understanding probabilities. I have taught classes on statistics and probability and know that it is difficult to help people gain an understanding.

I think the FDA is trying to head off the changes Congress is likely to make in the Kennedy-Enzi bill (not yet introduced), but that it is likely too little too late to avoid sweeping changes coming from Congress. While I applaud the initiative, I think it is being done with limited enthusiasm and later than many would like. Also, I do think that any Democratic back billed giving increased authority to the FDA will likely lead to a presidential veto if it gets through both houses of Congress.

Until the FDA has the ability to fine drug companies for not following through on their promises of post-marketing studies, I don’t think much will change. They need an ability similar to the EPA to allow the FDA to fine companies for not complying. Right now, the only alternative the FDA has is to remove a product from the market, something I think everyone agree should be a last resort. And it should be meaningful amounts that really make the drug company want to avoid fines. I would purpose that the drug company be fined the equivalent of whatever they earn on a daily basis. As an example, if a drug earns $1 billion in revenue annually, then the fine would be $2.8 million per day for every day late they are in starting a required study. Obviously there should be the ability for the company to present to the FDA why they can’t start a study and if the FDA concurs, then a new date would be set. Otherwise, the FDA starts the fines.

The other obvious need is for more money to be able to adequately do their job. If you look at the amount of the gross domestic product the FDA overseas, and then look at their percentage of the overall budget, it is vastly out of whack.

Here are some other articles on this news.

FDA proposes drug safety “report cards” (from BusinessWeek)
FDA to Monitor Post-Market Drug Safety (from HealthCentral)
PharmaLive: FDA Reinforces Commitment to Drug Safety

Other Resources

Yahoo! News Search Results for FDA drug safety
FDA drug safety - Google News