On September 22, 2006, the Institute of Medicine (IOM) issued a report in response to growing public concern with health risks posed by FDA approved drugs. In the report, IOM made substantive recommendations on how the FDA can improve its drug safety efforts. (See “FDA Drug Safety System Needs Fixing, IOM Report Says“)
This week, the FDA issued its own report, entitled “The Future of Drug Safety“, in response to the recommendations made by IOM. In its report, the FDA identified three key efforts to strengthen the drug safety system:
- Strengthening the science that supports the FDA’s medical product safety system at every stage of the product life cycle from pre-market testing and development through post-market surveillance and risk management
- Improving communication and information flow among all stakeholders engaged in promoting the safe use of medical products
- Improving operations and management to ensure implementation of the review, analysis, consultation, and communication processes needed to strengthen the U.S. drug safety system
In addition, The FDA has made additional recommendations tied to Congress’ reauthorization of the Prescription Drug User Fee Act (PDUFA).
The Pharmaceutical Research Manufacturers Association’s (PhRMA) Deputy Vice President, Alan Goldhammer, issued the following statement on FDA’s IOM response:
“When it comes to patient safety, there is always room for improvement. But the FDA, in its IOM response, makes clear that important efforts to improve drug development and safety have been underway for years and more promising initiatives have been proposed as part of the reauthorization of PDUFA.”
However, PDUFA reauthorization may come with strings attached. Senator Edward M. Kennedy, Chairman of the Health, Education, Labor, and Pensions (HELP) Committee along with Senator Mike Enzi, HELP Committee Ranking Member, have re-introduced the “Enhancing Drug Safety and Innovation Act”.
The issue of drug safety will be taken up by the HELP Committee in early Spring, when the committee considers the reauthorization of the Prescription Drug User Fee Act. Provisions in the Enhancing Drug Safety and Innovation Act of 2007 include:
- Risk Evaluation and Mitigation Strategy (REMS)
- Clinical Trials Databases
- Establishment of the Reagan–Udall Institute for Applied Biomedical Research
- Conflicts of Interest Disclosure
Drug Safety requires the attention of all constituents in the health care continuum. Above all, we must ensure the availability of complete and transparent information regarding drug use, interactions and side effects.
But all these proposals are for not, if we are not proactive in our own health care. As consumers, we must remember that there are no completely safe substances, even water has side effects. Drink enough H2O and you’ll get water intoxication.