Political Quotes

“Mr. Chairman, the FDA defense has been a topic of considerable discussion and controversy over the years. In the past I have supported the adoption of provisions affording the FDA defense. This was done based on my belief that strong support and appropriate oversight by the Congress would enable the FDA to provide thoughtful, careful review for drug and medical device approvals and scrupulous post-market surveillance, all of which are essential to the protection of the American consuming public. If this were to be the case, there would be no question but what Congress should afford the FDA approval as a defense against punitive damages. Regrettably, that appears not, however, to be the case. Times have changed and it appears that congressional support for FDA and support for a strong, viable, adequately-funded, well-staffed agency is at risk at this particular time. We have been hearing about privatizing, cutting back, reducing and eliminating FDA. It is my strong belief that until these questions have been satisfactorily resolved and until we are satisfied that FDA approval really means something, that we should not then afford a weakening of the civil suit process which affords protection to the American consumer from misbehavior by manufacturers of devices and prescription pharmaceuticals.”