FDA Chief Counsel Sheldon Bradshaw spoke for the first time before the generic industry at the Generic Pharmaceutical Association's (GPhA) policy conference in September, and his remarks were encouraging. Specifically, Bradshaw noted that citizen petitions are a growing concern not only for the generic industry, but for the agency as well.
Every US citizen has a constitutionally protected right to petition the federal government. Some brand name pharmaceutical companies, their lawyers, or others frequently file citizen petitions regarding pending Abbreviated New Drug Applications (ANDAs) with the FDA, however, on the eve of approval. Upon receipt, the FDA typically delays ANDA approval until the issue underlying the citizen petition is resolved. Citizen petition filings regarding ANDAs have increased in recent years, sometimes substantially delaying generic drug approval times and consumers' access to affordable medicines, while extending branded companies' product monopolies.
In his speech, Bradshaw said that he wants to ensure that generic approvals are not significantly delayed by citizen petitions. "The citizen petition process is in some cases being abused. Sometimes, stakeholders try to use this mechanism to unnecessarily delay approval of a competitor's products," said Bradshaw. "I've already seen several examples of citizen petitions designed not to raise timely concerns in respect to legality or timeliness of the drug application, but rather to delay approvals by compelling the agency to consider arguments raised in the petition, regardless of whether the arguments in the petition could have been argued months and months before. I've found that to be particularly troublesome."
In most cases, the FDA does not find the reasons outlined in the petitions to modify ANDA approval requirements to have any merit. "We would welcome ideas as to how we could improve the process, such as putting responses and approvals on 2 separate tracks," Bradshaw said. "Decoupling is certainly out there and seems an obvious solution," he continued, "but I want to hear other views."
GPhA welcomes that opportunity to present the views of the trade association and its members on this critical issue. Now that the FDA has recognized citizen petitions as an important issue, we are hopeful that it will continue to generate more attention at the agency. Consumer access to affordable medicine should not be delayed by citizen petitions that are questionable.Kathleen Jaeger, RPh
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