Copyright 1999 The Times-Picayune Publishing Co.
The Times-Picayune
July 14, 1999 Wednesday, ORLEANS
SECTION: NATIONAL; Pg. A9
LENGTH: 734 words
HEADLINE:
MAKER OF CLARITIN, GENERIC FIRMS TO BATTLE IN CONGRESS
BYLINE: By Frank Davies Knight Ridder Newspapers
DATELINE: WASHINGTON
BODY:
A high-stakes battle developing in Congress this summer has nothing to do
with party politics and ideology, and everything to do with large profits and
the cost of a popular allergy medicine.
The outcome will determine how
much consumers pay for Claritin, which generated $2.3 billion in sales last year
as the world's top-selling antihistamine, when its manufacturer's
patent expires in a couple of years and competitors can market
a cheaper generic version.
Schering-Plough of Madison, N.J., has hired a
battalion of well-connected lobbyists to secure a patent
extension three years beyond 2002. Last year the firm spent $4.2
million on lobbying for its interests, according to annual disclosure reports.
Consumer groups say allergy sufferers would pay 30 percent to 60 percent
less for a generic equivalent, based on data from a Congressional Research
Study.
Waiting in the wings are generic manufacturers like Ivax of
Miami, eager for a share of a lucrative market. The chairman of another generic
firm, Bruce Downey of Barr Laboratories in Pomona, N.Y., recently testified
before Congress that generics could offer the equivalent of Claritin to the
average user for about $15 a month, compared with the $87 a month it now costs.
The struggle between generics, brand-name firms and consumer groups
comes at a time when the high cost of drugs has grabbed
headlines. President Clinton has proposed Medicare coverage of prescription
drugs and GOP leaders are suggesting drug
subsidies for the poorest beneficiaries.
Congressional reports showed
drug prices rising 8 percent a year annually from 1990 to 1995,
and a study by the House Government Reform and Oversight Committee found that
senior citizens in the United States paid 81 percent more than Canadians for the
10 most popular drugs.
The money at stake is nothing to
sneeze at. Last year, Fortune Magazine found that the pharmaceutical industry
was the most profitable in the nation, based on rate of return on sales, assets
and equity.
Groups like Consumers Union and Public Citizen contend the
U.S. prices reflect excessive profits that should not continue for three more
years.
But Schering-Plough and the brand-name industry say the issue is
not profits but patent fairness. Drugs like
Claritin are expensive to develop, take years for the Food and
Drug Administration to review and approve, and, in the case of
Claritin, were in the pipeline for many years before they could be marketed.
Schering-Plough tried for two years to get a patent
extension through heavy lobbying late in the legislative year, trying
to tack a provision onto other bills. This year the manufacturer has adopted a
direct approach, with House and Senate bills establishing a review process in
the Patent and Trademark Office to extend the exclusive rights
on seven "pipeline" drugs that went through a lengthy review
process.
Critics counter that the House bill puts the burden of proof on
an opponent of the patent extension, takes the FDA out of the
review and almost guarantees continued exclusive rights for the brand-name
drugs. They also point out that Claritin has already received
two patent extensions since 1984.
Brand-name companies
get a set period, usually about 20 years, to make and market
drugs before generic companies are allowed to sell cheaper
versions.
The generic industry, which accounts for about 45 percent of
all prescriptions, has become more aggressive, even strident, in defending its
interests. When Schering-Plough launched its bid last fall for a patent
extension, Milan Puskar, the CEO of Mylan, the nation's largest generic
manufacturer, called it "an outrageous rip-off."
"You better bet if
Schering-Plough gets away with it, every brand-name company will try the same
shifty back-room tactics to protect their products from fair competition,"
Puskar said.
Jason Gross, director of regulatory affairs for an Ivax
subsidiary, said generics are reminding Congress that they too need lead time to
develop their products, based on the scheduled expiration of
patents for the brand names.
Rep. Ed Bryant, R-Tenn.,
who received $10,000 from Schering-Plough, and Rep. Jim McDermott, D-Wash., who
received $7,000, are co-sponsoring the patent extension bill in
the House. Senate sponsors include Florida Republican Connie Mack, who received
$10,000, and New Jersey Democrat Robert Torricelli, who received $5,000.
LOAD-DATE: July 14, 1999 
