Copyright 2000 Phoenix Newspapers, Inc.
THE ARIZONA
REPUBLIC
September 15, 2000 Friday, Final Chaser
SECTION: FRONT; Pg. A4
LENGTH: 463 words
HEADLINE:
BILL WOULD PAVE WAY FOR GENERIC DRUGS;
CONSUMERS COULD SAVE ON MEDICINES
DATELINE: WASHINGTON
BODY:
Sens. John McCain and Charles Schumer introduced a bill Thursday that they
said would create a more competitive prescription drug marketplace by clearing
logjams in the approval process for generic drugs.
The bill would
attempt to close legal loopholes that allow brand-name drug companies to stall
the entrance of cheaper generic drugs into the market, they said.
"This
bill could save consumers more than $71 million over the next 10 years by making
it easier for generic drugs to get on the market," said Schumer, D-N.Y. "It's
not a freebie for generic drugmakers. It simply levels the playing field so they
can offer consumers a choice at the counter."
Brand-name drug companies
argue that patents offer a way for them to recoup an average of $500 million
they spend on research, testing, failures and regulatory review to get a drug to
market.
"The Schumer-McCain bill is a one-sided approach that focuses
solely on expediting access of generic medicines. It fails to help patients
waiting for new medicines," said Jeff Trewhitt, spokesman for the Pharmaceutical
Research and Manufacturers of America, the trade group for brand drug companies.
"Intellectual-property protection is critical to encouraging private
investment in pharmaceutical research and development," he said.
But a
McCain aide said brand-name manufacturers try to protect their market dominance
by securing a large number of patents to delay generic products' approval.
"There tends to be an abuse of patents," said Sonya Sotak, legislative
aide with McCain's office. "The companies file frivolous patents, sometimes up
to 10, often for things like the shape or color of the pill, dark containers or
tablet markings."
As a remedy, the Schumer-McCain bill, called the
Greater Access to Affordable Pharmaceuticals Act, would require generic drug
companies to address the Food and Drug Administration about only two patents,
for active ingredients and method of use.
In the 1984
Hatch-Waxman Act, Congress set patent guidelines for drugs.
Since then, however, brand-name companies have found avenues to extend the
20-year exclusivity period a brand-name product receives with its patent.
The Pharmaceutical Research and Manufacturers of America argues that
drugs have only about 11 1/2 years of patent protection on the marketplace since
they are often patented while in the development and approval process.
McCain, R-Ariz., acknowledged that he did not foresee the bill passing
before Congress wraps up its session next month but said he "wanted to start
building support now."
"I don't see it as a panacea for the overall
prescription drug problem in America," he said. "But this will at least ease
some prescription prices by creating a stronger and more competitive
marketplace."
LOAD-DATE: September 27, 2000
