PDUFA has enjoyed success in reducing the average review times of new pharmaceutical products since 1992.  It would appear to be a no brainer as far as reauthorizing PDUFA before it sunsets on September 30, 2002; the President, Republicans and some Democrats in Congress, the Food and Drug Administration (FDA) and the pharmaceutical industry all support its reauthorization.

However, I would like to express my concern that the PDUFA in fact underscores the need for generic drugs to enter the market.  As resources within the FDA are allocated to approving drugs in accordance to user fees, it has been reported that limited FDA resources are taken away from other important areas within the agency, particularly, the areas within the FDA that are responsible for evaluating and approving generic drugs. 

The fact remains that the high cost of prescription drugs still remains one of the most pressing health care issues confronting our country’s senior citizens, employers, managed care plans, state and federal drug programs.  It also remains clear that generic competition can have a dramatic impact on reducing pharmaceutical costs.

There is an overwhelming and compelling need for statutory or legislative initiatives that allow timely access and availability of generic drugs.  However, here we are today preparing to reauthorize legislation that guarantees timely approvals of brand name drugs while leaving behind necessary generics from potentially entering the market.  

It is no surprise that we are having this hearing today since Congress has been dragging its feet on generic drug issues.  Congress has been so negligent in ensuring proper entry of generics to the market, that states have begun to act on their own, as we saw with the Governors’ resolution offered at the National Governors’ Association (NGA) meeting in Washington, DC last week.

The Governors’ resolution expressed concerns about the 1984 Hatch-Waxman Act.  Part of the intent of the Hatch-Waxman Act as to lawfully improve consumer access to lower-priced generic drugs.  The problem is that loopholes within the Hatch-Waxman Act are being taken advantage of and preventing the availability of generic drugs to enter the market.  Brand name companies have become proficient in manipulating the Hatch-Waxman law and launching aggressive campgains to block or delay generic alternatives from reaching the market.

This manipulation of Hatch-Waxman, coupled with FDA resources drawn to approvals of brand name drugs attached to a user fee, need to be brought to the forefront.  It is imperative during this debate on PDUFA that we highlight the fact that inclusion of generic drugs in the marketplace is great for consumers, employers and government purchasers because generic competition provides access to less expensive, therapeutically equivalent generic versions of brand name drugs.

Thank you, Mr. Chairman.