C o nsumers Union. org FDA gets failing grade on protecting patient safety Congress needs to act now!
The government's own investigative arm has found that the FDA has no clear policy for dealing with drug safety problems, and doesn't even have any real power to require drug makers to conduct safety studies when needed.
In fact, investigators found when a drug safety problem comes to light, the FDA lacks a system for deciding what actions to take and when.
So serious is the problem that the Government Accountability Office is recommending that Congress expand the FDA's authority over drug companies. Yet bills that would give the agency that power, as well as require drug studies be made public, languish on Capitol Hill.
Tell Congress you want to know why they aren't making drug safety a priority. Two bi-partisan bills that would require drug companies to release studies showing dangerous side effects, conduct further safety studies when problems arise, and allow quicker FDA safety warning labeling haven’t even had a hearing.
Act now! Ask Congress to hold hearings and vote on these bills, so we can have faith that the FDA is putting patient safety first.
Make drug safety a bigger priority!
Dear [Decision Maker],
I recently learned that our government's investigative arm has found significant problems with the FDA's drug safety process including a lack of simple criteria for determining when to take action when dangerous drugs may be on the market.
The Government Accountability Office (GAO) study also recommends Congress pass legislation so the agency can require drug companies conduct needed safety studies. I urge you to consider the GAO's recommendations, and support legislation (S 470, the Fair Access to Clinical Trials Act and S 930, the Food and Drug Administration Safety Act) that would significantly improve our drug safety system.
I expect the FDA to ensure that medications on the market are as safe and effective as possible. But the countless deaths linked to Vioxx, several antidepressants and now ADHD drugs has made me doubtful that Congress is taking seriously problems in our drug-safety system. To restore my faith that the government is doing all it can to ensure the medicines I take each day are as safe and effective, please support drug and medical device safety reform efforts this year.
The components of these bills would:
* Require drug companies to register and make public the results of their clinical drug trials so researchers, doctors and consumers would know about possible harmful side effects. Now, drug companies give those study results to the FDA but are not required to make them public, allowing drug makers to play up positive results and bury negative ones. Such was the case with Vioxx and Paxil.
* Give FDA new authority to require drug companies to conduct further safety studies of new drugs, and require them to take action to reduce risks. Currently, the FDA has very limited authority to require post-market safety studies or label changes to reflect drug risks, as the GAO report (Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process) points out.
* Make drug advertisements clearer for consumers. Ads for new drugs would be submitted to the FDA before they run, and would have to include information that provides a more accurate understanding about safety risks and uncertainties.
* More authority and a higher profile for Post-Market Drug Evaluation and Research at the FDA. Giving the agency the adequate tools and authority would ensure that post-market safety efforts are focused on protecting consumers.
These are common-sense measures that won't slow the flow of new, life-saving drugs and therapies to the market. Rather, they will make sure doctors, researchers and patients know about possible harmful side effects of drugs, and give the FDA the tools to take action when safety problems arise.
Congress shouldn't wait for any more unnecessary deaths and injuries to act. I urge you to support these measures now to ensure the safety of myself and my family when it comes to prescription drugs.