I want to mention several things Congress can do to increase access to low cost generic alternatives to name brand products.  

The first is to stop a practice being used by some in the brand industry to prevent generics from reaching the consumer.   These restrictive laws are being advanced despite a scientific finding by the FDA that the generic drug is equivalent and substitutable to the brand name product.   If this campaign is successful, the ultimate losers will be the senior citizens and other prescription drug users who will be forced to continue paying excessive brand prices for their medicines due to unfounded restrictions on access to generics.  

Congress needs to pass legislation prohibiting keeping generics off the market once the FDA has determined they are “therapeutically equivalent” to a brand name product.  I have introduced legislation titled the “Generic Drugs Access Act of 2001” which would accomplish just that, and I hope in light of the well documented price discrimination that seniors face today, this Committee will consider my legislation.

The second issue I wanted to mention concerns the lack of generic competition in the biotechnology industry today.  Currently there is no explicit regulatory pathway for the approval of generic biologics.  In my view, the lack of a clear regulatory framework for approving generic biotech products promises to become yet another obstacle blocking consumer access to lower cost alternatives.  Indeed, the patents on a number of giant biotech products have already expired and many more will expire in the next few years.   

Mr. Chairman, there is no scientific reason why biologics should be exempt from the Hatch-Waxman Act.  Seniors, the federal government and millions of other consumers will save enormous sums of money if an explicit framework for approving generic biologics can be established through statutory language.  Generic competition in the pharmaceutical industry has been an incentive for innovation at the same time it has lowered prices and I expect the same would happen in the biotechnology industry if Hatch-Waxman is expanded to include biologics.

Mr. Chairman, I am also concerned about the manner in which the FDA is implementing the pediatric exclusivity provisions of FDAMA.  The intent of the law was to create an incentive for companies to discover new uses in pediatrics for their products in exchange for 6 months of exclusivity for the work done.  The FDA’s interpretation of the law, however, has in essence been granting companies patent extensions without receiving the pediatric benefits it was intended to generate.  Two areas I am particularly concerned about are the ability of companies to use old studies to obtain patent extensions, and the granting of exclusivity based on “active moiety” rather than on a product- by-product basis.   
 
The pediatric exclusivity provision of FDAMA should be prospective and needs to be strengthened.  If it is not, it will continue to serve as yet another obstacle that blocks access to generic drugs for consumers, forcing seniors and others to pay higher prices because lower cost alternatives are needlessly kept off the market.

Mr. Chairman, the issue of dietary supplement regulation is not progressing in a timely manner.  The industry and the public have been asking for the proposed final regulations for Good Manufacturing Practices and the publication is still pending at the FDA.  The discussion today examines modernization of the FDA, yet it is taking more than six years to get quality standard regulations for dietary supplements.  
 
In addition, we are eagerly awaiting publication of the Department of Health and Human Services Inspector General’s report seeking tighter regulations on dietary supplements.  The final draft of the report requires mandatory reporting of supplements and their ingredients.  Not only does the draft report unfairly paint a biased picture of the industry, it also understates the benefits of supplements.

Lastly, Mr. Chairman, this country is facing a crisis in food safety.   The FDA is in need of food safety modernization in terms of better inspections and better labeling.  I will be introducing two bills to address these issues, but I want to highlight the fact that the Bush Administration’s food safety record in its first 100 days amounts to nothing.  I’m interested in hearing from Dr. Applebaum of the National Food Processors Association on this urgent issue.

Thank you, Mr. Chairman, I look forward to hearing from the panelists on these important issues.