Introduction of the "Swift Approval, Full Evaluation (SAFE) Drug Act"

By:  Ed Markey
Date: Feb. 16, 2007
Location: Washington, DC


* Mr. MARKEY. Madam Speaker, I rise today to introduce the Swift Approval, Full Evaluation, SAFE, Drug Act. This bill is designed to ensure that the FDA can balance the need to get important life-saving drugs to the market quickly while ensuring the drugs get the full evaluation they need to ensure the safety of those products.

* Earlier this week the Oversight and Investigation Subcommittee of the Energy and Commerce held its very first oversight hearing of the 110th Congress on drug safety. At the hearing several FDA whistleblowers testified about the truly frightening problems at the FDA including: 1. a culture of suppression and intimidation, 2. a lack of transparency into the review process, 3. the inaction of FDA management in response to serious drug risks, 4. a lack of scientific freedom and the inability of FDA reviewers to have their concerns heard by senior management, FDA advisory committees, and the public.

* Their powerful testimonies add to the concerns raised in the Institute of Medicine report, the GAO Report, and the Inspector General of HHS report that the FDA's system to ensure that postmarketing studies are conducted and completed is broken and the FDA has not made reform a priority.

* It is clear from the whistleblowers' testimonies and these three major reports that the FDA is a deeply troubled agency that has failed time and time again to act in the best interest of the public. The failures of the FDA to protect the public have been widely reported by the media and the public is losing confidence in the FDA's ability to keep us safe.

* According to a recent Wall Street Journal Online/Harris Interactive poll, 80 percent of adults say they are concerned about the FDA's ability to make independent decisions that will ensure that patients have access to safe and effective medicines.

* We need the FDA to be a watchdog for public health, not a lapdog for the industry. We need to bring back transparency, accountability and scientific integrity to the FDA.

* That is why today I am reintroducing the Swift Approval, Full Evaluation, SAFE, Drug Act to provide greater transparency into the approval process and a stronger postmarket safety system.

* The SAFE Drug Act will:

* 1. Increase FDA authority with respect to postmarket safety, including giving the FDA the ability to mandate labeling and require postmarket studies.

* 2. Provide FDA greater authority with respect to the Accelerated Approval process, by ensuring postmarket study plans are reviewed prior to approval; requiring proper labeling until drugs are fully approved; and restricting advertising for accelerated approved drugs or biologics until full approval.

* 3. Provide enhanced whistleblower protections to FDA employees.

* 4. Preserve scientific integrity at FDA by prohibiting FDA employees from directing other FDA employees to censor or suppress scientific research, analysis, opinions or recommendations or directing employees to disseminate scientific information that is known to be false or misleading.

* 5. Require the FDA to provide Advisory Committees with complete information.

* 6. Ensure scientific freedom at FDA, by guaranteeing FDA and FDA-sponsored authors the right to publish or present their work.

* 7. Increase FDA transparency, by requiring a biennial report to Congress on noninferiority studies and a biannual report to Congress on postmarket studies system.

* The time to act is now. I look forward to working with my colleagues to stop the erosion of public confidence in the FDA, provide greater transparency into the approval process, reform the system of postmarketing studies, and ensure that FDA balances the desire to speed drugs to market with its critical role as the watchdog of public health.

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