From: Buehler, Gary J Sent: Thursday, July 31, 2003 10:39 AM To: Dockets, FDA Subject: FW: Your aid is requested please -----Original Message----- From: Ane [mailto:lama.palmo@verizon.net] Sent: Tuesday, July 29, 2003 4:26 PM To: buehler@cder.fda.gov Subject: Your aid is requested please Gary Buehler, Director Dockets Management Branch RE: Immediately Approve ANDAs For Generic Ribavirin 200mg Capsules Deny Delay Tactic “Citizen Petition” of Brand Manufacturers – Docket# 2003P-0321 Dear Director Buehler and Dockets Management staff, I am writing to strongly urge FDA to immediately approve generic ribavirin capsules for use in the treatment of hepatitis C and to oppose the recently submitted “Citizen Petition” by the brand manufacture of this drug simply designed to delay that approval. The petition is yet another tactic by brand drug makers to misuse the FDA in a desperate effort to deny people with hepatitis C legal and timely access to competitive, safe, effective, lower cost equivalent treatments. Please approve generic ribavirin applications as soon as possible! Thank you, AK Palmo Frontline Hepatitis National HepC line: 1-866-hep-gogo WA State: 360-805-1700 http://frontline-hepatitis-awareness.com "We Care Because YOU Are There" Tuesday, July 29, 2003 Gary Buehler, Director Dockets Management Branch RE: Immediately Approve ANDAs For Generic Ribavirin 200mg Capsules Deny Delay Tactic “Citizen Petition” of Brand Manufacturers – Docket# 2003P-0321 Dear Director Buehler and Dockets Management staff, As a patient advocate and a person living with Hepatitis C, I am writing to strongly urge FDA to immediately approve the ANDAs for generic ribavirin capsules and deny the misnamed “Citizen Petition” (docket # 2003P-0321) actually submitted by the brand manufactures of this drug. The Petition has no merit, should be denied, and should not delay the immediate approval of these ANDAs. Hepatitis C community members and healthcare professionals are well aware that the pertinent patents and/or market exclusivities for brand ribavirin manufacturers expired in December, 2001, which should have made way for legal entry of generic competition of the drug. Generic makers filed ANDAs 6 months prior to that date in preparation for that legal competition. As expected, the brand manufactures filed the usual frivolous patent infringement lawsuits in order to delay the ANDA approvals and competition, for up to 30 months. The usual catch –22 ensued, with the courts waiting to see the FDA application and labeling approvals before ruling; and the generics division of FDA, sitting on the fence, slowing even the processing of those applications, hoping the courts would make a decision w! ithout them. The brand manufacturer’s lawsuit being baseless, Summary Judgment was ruled in federal court against the brand drug makers on July 14, 2003. The day after that ruling, this “citizen petition” was submitted to FDA. The petition contradicts actual law, and has nothing to do with the safety, efficacy or even valid labeling of the drug. It is simply a last ditch delay tactic, to continue to misuse the FDA regulatory function to make the 30-month decision period a de facto 30-month extension of market exclusivity. The intent of pharmaceutical patents and market exclusivities is to give, for a limited time, brand manufacturers a rightful reward, for their research and development of safe and effective innovative pharmaceuticals. The intent of FDA generic regulation is to allow safe and effective generic versions of those drugs to enter the market when that time has expired; this in turn allows lower cost competition and greater access to people in need of those medications; in this case greater access to people living with hepatitis C. The actions of the brand manufacturer in the current situation regarding ribavirin are a shameful perversion of the intent of these laws and the FDA’ s regulatory function and process. The FDA has the regulatory authority to stop it now, if it chooses to do so. Deny the so-called “citizen petition” and immediately approve the ANDAs for generic ribavirin. You may contact me at any time regarding this matter. Thank you, AK Palmo Frontline Hepatitis National HepC line: 1-866-hep-gogo WA State: 360-805-1700 701 W. Elizabeth #54 Monroe, WA 98272 http://frontline-hepatitis-awareness.com "We Care Because YOU Are There"