E-DRUG: USA "Greater Access to Affordable Pharmaceuticals" Act
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[optimistic name... I was not aware that many people had
access to affordable pharmaceuticals in the USA already?
Anyway, maybe the international debates of excessive drug
pricing are finally coming home?
Crossposted from Pharm-Policy with thanks.
NN]
May 1, 2001
Public Citizen Applauds Introduction of Schumer-McCain Bill to Make Less
Costly Generic Drugs More Widely Available
WASHINGTON, D.C. - Public Citizen today applauded Sens. Chuck Schumer
(D-N.Y.) and John McCain (R-Ariz.) for introducing legislation to provide
consumers with much more timely access to less costly generic prescription
drugs. The legislation is called the "Greater Access to Affordable
Pharmaceuticals Act."
"This much-needed legislation will make it harder for the major drug
companies to use legal tricks to deny consumers the ability to purchase
more affordable generic drugs," said Frank Clemente, director of Public
Citizen's Congress Watch. "It will save consumers billions of dollars in
coming years from lower drug costs."
Schumer-McCain closes loopholes in the Drug Price Competition and Patent
Restoration Act of 1984 (Hatch-Waxman Act) that have allowed brand name
drug companies to keep generic drugs off the market.
Hatch-Waxman was designed to increase timely access to generic drugs while
ensuring that drug manufacturers have adequate patent protection to
justify their investment in research and development. But loopholes in the
act have allowed drug companies to delay generic drugs from coming to
market by doing such things as paying firms to withhold generic drugs from
the market and filing nuisance lawsuits that automatically delay the
introduction of generics. Although the Hatch-Waxman Act has succeeded in
opening the prescription drug market to generic competition, generics now
constitute less than 10 percent of the dollar value of all prescription
drugs sold in the United States, according to the National Institute for
Health Care Management.
Solutions in the Schumer-McCain bill include:
� Eliminating the automatic 30-month stay in current law that has allowed
brand name drug companies to keep generic drugs off the market by filing
nuisance suits. The bill would require that brand name drug companies,
just like patent holders in any other industry, prove in court why they
ought to be granted a temporary restraining order preventing a
competitor's product from coming to market;
� Limiting collusion between brand name companies and generic firms that
agree to withhold their drugs from the market. The bill would deny
180-day exclusivity to a generic company if it does not aggressively
attempt to bring a generic version of the brand name company's product to
market; and
� Requiring entities filing citizens' petitions to disclose if they are
acting on behalf of a brand name drug company to keep a generic off the
market. Such petitions can be filed with the U.S. Food and Drug
Administration (FDA) by anyone seeking to prevent a drug from being
marketed. Brand name drug manufacturers increasingly using these petitions
to keep generic competition at bay. Such petitions can delay the
introduction of a generic alternative for a long time because the FDA is
required by law consider each one.
"Brand name hegemony is partly due to the manipulation of the Hatch-Waxman
Act by the major drug companies that successfully extend their lucrative
patents beyond what was intended by the law," Clemente said. "Loopholes
have led to ever greater profits for brand name firms but exorbitant costs
for consumers. The manipulation of the market has to be stopped and this
bill will do it."
The new legislation comes at an important time. Brand name drug companies
often charge U.S. consumers nearly twice as much as they charge consumers
in other industrialized nations for the same prescription drugs. In the
next five years, prescription drugs with annual sales of approximately $20
billion will be coming off patent. Given that generic drugs cost, on
average, less than a fifth of what brand name drugs cost under the
Medicaid program, the potential savings to taxpayers, consumers and
patients from the timely availability of generic drugs is substantial.
Despite the Hatch-Waxman Act's loopholes, the legislation has been
successful in saving consumers huge amounts of money by increasing their
access to generic drugs. The Congressional Budget Office (CBO) estimates
that the first year a generic drug becomes available, it offers consumers
a 25 percent savings, on average. The CBO has concluded that Americans
saved $8 billion to $10 billion in 1994 alone by purchasing generic drugs.
But if the act's loopholes were closed, consumers would save even more,
Clemente said.
### Public Citizen is a nonprofit consumer advocacy
organization based in Washington, D.C. For more information, please visit
www.citizen.org. For more information about Public Citizen's work on
prescription drug issues go to
http://www.citizen.org/congress/fda/index.html