IOM Issues Report Calling For Change At FDA
The Institute of Medicine issued a largely negative report on the FDA’s efforts to ensure that prescription drugs are safe and effective today. According to the IOM:
“Lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs’ risks and benefits have hampered the U.S. Food and Drug Administration’s ability to evaluate and address the safety of prescription drugs after they have reached the market, says a new report from the Institute of Medicine. Noting that resources and therefore efforts to monitor medications’ risk-benefit profiles taper off after approval, the committee that wrote the report offered a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used. Recommendations include:
- Labeling requirements and advertising limits for new medications
- Clarified authority and additional enforcement tools for the agency
- Clarification of FDA’s role in gathering and communicating additional information on marketed products’ risks and benefits
- Mandatory registration of clinical trial results to facilitate public access to drug safety information
- An increased role for FDA’s drug safety staff
- A large boost in funding and staffing for the agency”
The FDA’s acting commissioner, Dr. Andrew von Eschenbach responded to the IOM’s report, saying:
“As the IOM report recognizes, much progress and reform of FDA’s safety oversight enterprise is already underway. Specifically, the FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues. All drugs have risks. Our challenge is to uncover these risks as soon as possible. Through initiatives like Critical Path and Personalized Medicine, we are also working to improve the tools we use, to more effectively evaluate new products and processes.
I am committed to taking additional steps and will look to the initiatives recommended by the Institute of Medicine, to ensure we continue to fulfill our mission. Over the next months you will be hearing extensively from us about these new endeavors, including a number of initiatives aimed at improving the opportunities for employees of FDA to shape a more effective work environment.”
September 26th, 2006 at 10:15 am
One has to wonder if the new regs are going to do more harm than good. People are becoming overly cautious with these new drugs, and because of that, sick people aren’t going to get the medicine that they need, and that is a shame. This Guy tells it pretty well. These regulations help the powers that be save face, but what about the patients?
September 26th, 2006 at 11:02 am
Well, I have to say that regulations are often adopted after a perceived crisis. I think that most people looking at the slew of drug withdrawals over the past few years (I think the number is at 3%) has to recognize that we do need better safeguards to ensure that drugs are truly safe and effective. More post-approval safety studies are needed as well.
I think that the pendulum should not swing too far back to where it was in the pre-PDUFA era where needed drugs weren’t getting to people. However, we do need procedures in place to ensure that people know the drug they are taking is safe AND what side effects it may have.
I’m a strong believer in providing clear, actionable information to patients about drug side effects. This can help pharma companies, regulators, physicians and patients. It may also reduce the odds that drug firms have to defend against lawsuits prompted by drug withdrawals.