[Congressional Record (Bound Edition), Volume 145 (1999), Part 2]
[Extensions of Remarks]
[Page 2876]
[From the U.S. Government Publishing Office, www.gpo.gov]




          INTRODUCTION OF THE GENERIC DRUGS ACCESS ACT OF 1999

                                 ______
                                 

                        HON. FRANK PALLONE, JR.

                             of new jersey

                    in the house of representatives

                       Tuesday, February 23, 1999

  Mr. PALLONE. Mr. Speaker, the high cost of prescription drugs is one 
of the most pressing health care issues confronting the country's 
senior citizens, employers, managed care plans, state and federal drug 
programs. Controlling drug costs will be no easy task. One time-tested 
method, however, is timely access and availability of generic medicines 
once the patent on brand name drugs expires.
  Generic competition has a dramatic impact on pharmaceutical costs. 
When a generic drug first comes onto the market, it typically costs 30 
percent less than the brand name version. After two years on the 
market, the prices drop further to 60 or 70 percent of the brand name 
drug. The price of some generic drugs drop by as much as even 90 
percent.
  While these competitively priced alternatives are good for consumers, 
employers and government purchasers, they are not good for the brand 
name producer trying to maintain and protect monopolistic pricing. If 
there is no generic alternative available, consumers who need medicine 
have no choice but to buy the available brand drug and pay whatever it 
costs. It is for this reason that brand name drug companies launch 
aggressive campaigns to block or delay generic competition.
  One tactic used by the brand industry to prevent generics from 
reaching the consumer is to convince state legislatures to pass 
unnecessary restrictions to the substitution of generic versions of 
brand name drugs. These restrictive laws are being advanced despite a 
scientific finding by the Food and Drug Administration (FDA) that the 
generic drug is equivalent and substitutable to the brand name product. 
The state campaign is nothing more than an attempt by the brand name 
companies to protect market share.
  If these tactics are successful with the states, generic 
manufacturers could end up having to comply with 50 different sets of 
state laws before their products could ever reach the consumer. If 
would render the FDA stamp of approval meaningless. And it will only 
add extraordinary hoops for doctors and pharmacists to jump through 
before a generic medicine is dispensed. The ultimate losers are the 
senior citizens and other prescription drug purchasers who will be 
denied the access to equivalent generics and are forced to continue 
paying excessive brand prices for their medicines.
  The bill I am introducing today, the Generic Drugs Access Act, would 
prevent drug companies from gaming the system. Very simply, this bill 
prohibits states from passing laws keeping generic drugs off the market 
once the FDA has determined that a generic drug is ``therapeutically 
equivalent'' to a brand name product. Most importantly, it will ensure 
that generic drugs get to the market in a timely fashion and provide 
consumers with access to low cost alternatives at the earliest possible 
time.
  I urge my colleagues to lend their support to the effort to ensure 
low cost alternatives to brand name drugs are readily available to 
consumers and cosponsor the Generic Drugs Access Act of 1999.

                          ____________________