As you know, the high cost of prescription drugs is one of the most pressing health care issues confronting our country’s senior citizens, employers, managed care plans, state and federal drug programs.  Although controlling drug costs is not an easy task, generic competition can have a dramatic impact on reducing pharmaceutical costs.  I strongly support necessary changes to the Drug Price Competition and Patent Term Restoration Act, or Waxman-Hatch Act, that would allow timely access and availability of generic drugs once the patent on brand name drugs expires. 

The inclusion of generic alternatives 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.  Brand name companies have become proficient in manipulating the Waxman-Hatch law and launching aggressive campaigns to block or delay generic alternatives from reaching the market.  
 The intent of Waxman-Hatch was to provide a balance between brand name drugs and generic drugs in the marketplace.  Currently, the scales are tipped heavily in favor of the brand name companies.  This is clear from the number of pieces of legislation that have successfully extended patents on blockbuster drugs and reaped in extraordinary profits for these brand name companies.  The balance in the marketplace needs to be restored for the benefit of the consumer, and an examination of Waxman-Hatch can be done through the McCain-Schumer bill.

I would like to talk a little bit about how the big name drug companies have several frequently used methods to delay generic competition.  One of their favorite tactics is to make insignificant changes to their products and secure new patents just as the patent on their original product is set to expire.  New patents are granted by the patent office for frivolous and invalid reasons, such as changing the color of the bottle from which the drug is dispensed, however, once the new patent is presented, current law protects these brand name companies by prohibiting a generic from going on the market for 30 months. 

Another favorite method used by the brand name industry to manipulate the intent of Hatch-Waxman is inserting patent extensions into legislative vehicles.  In the interest of keeping pharmaceutical drug costs down, Congress should reject attempts by the brand industry to extend patents on profitable drugs by finding sponsors to inconspicuously insert patent extensions into legislative vehicles. 

In addition, the misuse of citizen petitions by brand companies is widely used to delay the approval of generic drugs.  Often times, brand name companies file a citizen petition with the FDA as a method of blocking the regulatory process.  As a result, brand name companies are afforded months or even years of monopoly.  Agency officials reviewing these petitions are administratively challenged and this leaves the review and approval of generic drugs on the back burner.  This is an example where legislative changes could prevent a citizen petition from delaying the approval of a generic drug that would ensure patient safety and improve access to necessary prescription drugs.

The tactics of the brand name industry to delay generic drugs from entering the marketplace are widespread and well-known.  I am very concerned about this issue and would like to open up Waxman-Hatch to find avenues that would stop this delay.

Thank you, Mr. Chairman.