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Consumer Group Critical of House for Failing to Take Up Legislation Easing
Access to Lower-Priced Generic Drugs
October Hearing on Drug Competition Is a Fig Leaf for Inaction
October, 2002
WASHINGTON, D.C. - Public Citizen criticized the leadership of the U.S. House of
Representatives for failing to act on legislation that would assure consumers
timely access to lower-priced generic drugs. That access could save consumers
and government programs $60 billion over 10 years.
The Greater Access to Affordable Pharmaceuticals Act (GAAP) passed the Senate in
July by a 78-21 vote, with almost all Democrats and a majority of Republicans
voting in favor. In the House, however, the legislation has been neglected by
the committee of jurisdiction since being introduced in May. Now, instead of
marking up the bipartisan Senate-passed legislation, the Energy and Commerce
Committee's Health Subcommittee today is holding a hearing to investigate the
problem of "competition" in the pharmaceutical marketplace.
"Consumers do not need Congress to study drug industry competition," said Frank
Clemente, director of Public Citizen's Congress Watch. "They need legislative
relief from high drug costs. It appears that the drug industry's hefty campaign
contributions and well-oiled lobbying operation have succeeded in persuading
Republican leaders to block passage of this pro-consumer bill. This hearing is
just a fig leaf to cover up inaction."
The high cost of prescription drugs is a significant problem for consumers. In
2001, the 50 top-selling drugs, such as Celebrex, Accutane and Allegra, posted
average price increases almost three times greater than the rate of inflation.
Timely access to generic drugs, which contain the same active ingredients as
their branded counterparts and sell for 20 to 50 percent less, can mean
significant savings for consumers. In July, the Congressional Budget Office
found that the Senate-passed GAAP Act would save consumers and government health
programs $60 billion over 10 years by closing loopholes in the law exploited by
brand-name drug companies to prevent generics from coming to market.
The Senate-passed legislation's most important pro-consumer elements, which are
embodied in H.R. 5311, sponsored by Reps. John Thune (R-S.D.) and Jo Ann Emerson
(R-Mo.), and H.R. 5272, sponsored by Reps. Sherrod Brown (D-Ohio) and Henry
Waxman (D-Calif.), would:
 | Limit brand-name drug companies to one 30-month stay of generic competition.
Under current law, brand-name drug companies can receive multiple, automatic
30-month stays that prevent lower-cost generic drugs from coming to market. All
a brand-name company must do to obtain a stay is claim in court that a generic
drug would infringe on one of its patents if it went to market. The GAAP Act
would limit brand-name drug companies to one automatic 30-month stay.
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| Create protections against the abuse of the automatic 30-month stay.
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| Establish deadlines for filing patents eligible for the automatic 30-month
stay. Only patents that are declared and listed by brand-name drug companies
with the U.S. Food and Drug Administration (FDA) up to 30 days after the time of
approval of the brand-name drug would be eligible for the automatic 30-month
stay.
Much of the mischief done by brand-name drug companies is done with late-listed
patents. For example, the day before Bristol-Myers Squibb's primary patent on
its anti-anxiety drug BuSpar was scheduled to expire, the company obtained
another patent on a metabolite - a breakdown product of the drug created
naturally in the body. Consumers were deprived of a lower-priced generic
alternative for almost half a year. Mylan Laboratories, a generic competitor
that was about to ship an alternative to BuSpar on the day that Bristol-Myers
Squibb's primary patent was set to expire, literally had to unload its delivery
trucks. Under the GAAP Act, Bristol-Myers Squibb's late-listed metabolite patent
would not have been eligible for an automatic 30-month stay.
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| Remove legal barriers preventing bogus patents from being challenged in court.
Under current law, brand-name drug companies can file frivolous patents with the
FDA to secure additional 30-month periods free from competition against their
high-priced products. The GAAP Act would give generic companies the ability to
challenge the listing of bogus patents with the FDA in court before they can
become the basis for an automatic 30-month stay.
Together, these protections would ensure that generic drug companies could clear
away legal obstacles preventing lower-cost generic drugs from coming to market.
Not only will generic drug companies have the tool they need to stop bogus
patents from interfering with bringing generics to market, but the requirement
for the timely listing of patents will ensure that generic companies will have
the time to go to court to challenge bogus patents that could become the basis
for an automatic 30-month stay.
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| Stop collusion between generic and brand-name drug companies that delays
consumer access to lower-cost generics. The GAAP Act changes the law so that
brand-name drug companies will no longer be able to stop all competition to
their products by paying one generic company to stay off the market. |
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Last Updated on
02/20/2005
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