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Letter to Andrew von Eschenbach, Commissioner of the FDA, Re: Implement Law Lowering Prescription Drug Prices


Location: Washington, DC

Stabenow Urges Administration to Implement Law Lowering Prescription Drug Prices

Legislation Increases Access to Affordable Generic Drugs

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
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.


Senator Debbie Stabenow (D-MI)
Senator Dick Durbin (D-IL)
Senator Chuck Schumer (D-NY)
Senator Claire McCaskill (D-MO)
Senator Sherrod Brown (D-OH)
Senator John Thune (R-SD)
Senator Chuck Grassley (R-IA)

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