Sens. Kennedy and Enzi present drug safety bill
Sens. Edward Kennedy (D-MA) and Mike Enzi (R-WY) have re-introduced their Enhancing Drug Safety and Innovation Act to require better safety planning before a drug is approved, while improving FDA's response to risks identified after the drug is on the market.
A release from Kennedy's office said the bill will:
• integrate safety issues and the approval process by requiring earlier and more focused consideration of safety issues;
• establish a flexible planning mechanism to obtain necessary safety info about each new drug;
• permit adaptation of the safety plan in response to new info; and
• bring fairness and timeliness
to the dispute resolution process.
Other key provisions cover:
• establishing a collaboration among FDA, academic research institutions, and the biomedical research industry to improve the process of drug development and evaluation and advance the FDA's critical path initiative;
• establishing a database of clinical trials to help enrollment in trials, provide a mechanism to track progress and ensure that the results are made public, and that patients, doctors and pharmacists have current info; and
• improving the FDA's screening of advisory committee members for financial conflicts of interest to ensure that these committees provide independent expert advice, and to bolster the credibility of the review process.