Legislation Increases Access
to Affordable Generic Drugs
WASHINGTON —U.S. Senator Debbie Stabenow (D-MI) yesterday sent the
following letter to the Commissioner of the U.S. Food and Drug Administration
Andrew von Eschenbach, MD., urging the administration to implement her
FDA provision, which was signed into law last year. Her provision will
put an end to frivolous petitions used by brand drug companies to delay
the entrance of generic drugs into the marketplace, robbing consumers
and businesses of affordable choices.
Full text of the letter follows:
April 9, 2008
Andrew von Eschenbach, MD
Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Commissioner von Eschenbach,
We are writing to express our concerns regarding the delay in implementation
of Section 914 of H.R. 3580, the Food and Drug Administration Amendments
Act. As you know, the President signed this bill into law on September
27, 2007. Section 914 will curb brand pharmaceutical companies’
practice of filing frivolous citizen petitions to delay consumers’
access to affordable generic medicines.
This provision was necessary because the FDA does not approve an abbreviated
new drug application (ANDA) for a generic product until all underlying
issues in a citizen petition concerning the drug have been addressed.
Some brand companies routinely file citizen petitions on an ANDA on
the eve of the generic product’s approval, sabotaging the marketing
of a cost-saving generic for months, if not years. According to a Merrill
Lynch review of citizen petitions filed between 2000 and 2005, more
than three-quarters of them were dismissed as having no merit.
It was very clear to us that these petitions have been strategically
timed to delay generic competition, effectively creating a free patent
term extension for the brand companies without any congressional oversight
or approval. Therefore, we included citizen petition reform in H.R.
3580 to ensure timely access to more affordable generic medicines.
Although the citizen petition provision has been in law for more than
six months, it is unclear to us whether or to what extent FDA has taken
steps to implement this provision. At a time when healthcare costs continue
to increase exponentially, we cannot afford the added delay in the approval
of lower-cost generic pharmaceuticals.
Given the impact skyrocketing health care costs are having on federal
health programs, as well as on the pocketbooks of American consumers,
it is imperative that this provision be implemented in a timely fashion.
We respectfully request a
timely response on what steps FDA has taken toward implementation, and
a timeline for future steps to ensure compliance with Section 914.
Sincerely,
Senator Debbie Stabenow (D-MI)
Senator John Thune (R-SD)
Senator Dick Durbin (D-IL)
Senator Chuck
Grassley (R-IA) Senator Chuck Schumer
(D-NY)
Senator Claire McCaskill
(D-MO) Senator Sherrod Brown (D-OH)
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