Drug Topics - March 31, 2008 - (Page 5) 5 changes to current proposals, the association is willing to wait for a new political climate in 2009. Citizen petitions Citizen petitions have long been a thorn in the side of generic drugmakers. Brand-name manufacturers typically petition the Food & Drug Administration to delay a generic product just before its expected approval. The result, GPhA said, is a delay in the Abbreviated New Drug Application that can last months to years. During Congressional testimony in 2006, FDA reported that just three of 42 citizen petition responses between 2001 and 2005 led to a change in agency policy. GPhA started pushing for changes in the citizen petition process in 2005. In 2007, the Food & Drug Administration Revitalization Act (FDARA) included several changes designed to curb the delays caused by groundless petitions. The most important provision, Hofelich said, is a requirement that FDA take final action on every citizen petition within six months of receipt. FDA is also required to move ahead with ANDA review and approval unless the petition has raised significant health issues. Now GPhA is trying to convince FDA to follow the new rules. “Citizen petitions are a significant barrier to access (of generic drugs),” Jaeger told the GPhA annual meeting. “Congress took an important step in helping to curb the brand industry’s abuse of the citizen petition process. However, in Washington, a mandate does not always mean ‘problem solved.’ FDA needs to implement this mandate and Congress must provide the agency with the necessary resources to do so.” al Democrats crafted a new Trade Policy for the Americas. Key changes include new labor standards, multilateral environmental agreements, protections for investors, changes to government procurement rules, and less restrictive approval procedures for generic medicines. The new policy was first implemented in the Peru Free Trade Agreement signed late last year. Similar provisions will be included in FTAs being negotiated with Colombia and Panama. Patent reform Patent reform is another key area for GPhA. Legislation has already passed the House, Hofelich said. The Senate plans to take up debate in April. “Legislation is now pending that could change patent protections in important ways,” Hofelich said. “Patent reform doesn’t just affect the pharmaceutical industry. Every industry is keeping an eye on the bills.” One of the most important provisions for generic drugmakers is equitable conduct. Equitable conduct essentially requires patent filers to be honest in filing patent claims, explained Frederick Killion, executive VP and general counsel for Barr Laboratories at the GPhA annual meeting. In the drug industry, that means filing realistic patent claims based on genuinely new ideas and innovations rather than overly broad claims. A claim based on a newly discovered chemical reaction or a molecule that affects a specific step in a specific biologic pathway would be equitable. A claim for all agents utilizing the oral route of administration would be inequitable. So would a claim based on misrepresentations of material fact or a claim that was intended to deceive the patent office. “If you remove that equitable conduct requirement, brand companies could file whatever wild claims they want,” Hofelich said. The House bill weakens equitable conduct requirements, Killion warned. That invites misconduct in patent filings. The Senate bill essentially codifies current law. Another important provision under attack is best mode. This requires patent claimants to disclose the very best method they know to produce the product being patented, explained Boston patent attorney Elaine Herrmann Blais, partner at Goodwin Procter LLP, at the same meeting. Under current law, failure to disclose the best mode can invalidate a patent. The House bill would defang best mode by eliminating patent invalidation for failing to disclose the best method of production. The Senate bill does not mention best mode. “The idea is let researchers and future patent filers improve on the very best current knowledge and practice,” Hofelich said. “Best mode will probably survive. Almost every industry finds it to its advantage.” DT User fees GPhA is willing to help ease FDA’s financial burden. The association is talking with the agency about user fees. “When the brand industry negotiated user fees with FDA years ago, there were major challenges,” Hofelich said. “Industry asked for progress measures, goals, and accountability in return for their dollars. Those are very similar to the kinds of things we are looking for in return for our dollars.” Talks began last summer, Hofelich said, but the association is not predicting how long discussions might last. Free trade agreements Trade agreements are another hot topic for GPhA. Many free trade agreements (FTAs) were negotiated without any representation by the generic drug industry. Not surprisingly, Hofelich said, FTAs almost always favor the branded segment of the industry. Typical restrictions include longer patent terms than in the United States and more restrictive generic entry provisions. But old attitudes are changing. In 2007, Congression-
Table of Contents Feed for the Digital Edition of Drug Topics - March 31, 2008 Drug Topics - March 31, 2008 Contents NCPDP Eyeing Standards for e-MARs for Nursing Home Patients GPhA: Tackling Key Issues of the Day New Products Latest News Roundup Drug Topics - March 31, 2008 Drug Topics - March 31, 2008 - Contents (Page 1) Drug Topics - March 31, 2008 - Contents (Page 2) Drug Topics - March 31, 2008 - NCPDP Eyeing Standards for e-MARs for Nursing Home Patients (Page 3) Drug Topics - March 31, 2008 - GPhA: Tackling Key Issues of the Day (Page 4) Drug Topics - March 31, 2008 - GPhA: Tackling Key Issues of the Day (Page 5) Drug Topics - March 31, 2008 - New Products (Page 6) Drug Topics - March 31, 2008 - Latest News Roundup (Page 7)
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