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Strategies That Delay Market Entry of Generic Drugs
JAMA Internal Medicine ( IF 39.0 ) Pub Date : 2017-11-01 , DOI: 10.1001/jamainternmed.2017.4650
Kerstin Noëlle Vokinger 1 , Aaron S. Kesselheim 1 , Jerry Avorn 1 , Ameet Sarpatwari 1
Affiliation  

Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although generic competition helps lower drug prices, manufacturers of brand-name drugs often work to delay the availability of generic versions of their products. Strategies to forestall generic competition include patenting peripheral aspects of a drug or modified formulations that do not add clinical value, paying generic manufacturers to settle lawsuits challenging the validity of patents on brand-name drugs (“reverse payment” settlements), denying generic manufacturers access to drug samples necessary for bioequivalence testing, misusing risk evaluation and mitigation strategies, and filing citizen petitions with the US Food and Drug Administration (FDA). To address such tactics, the federal government can interpret existing patenting standards more strictly and promote certain types of patent challenges to ensure that patents are granted or upheld only for true innovations. Congress can enact pending legislation that would help discourage reverse payment settlements and compel brand-name manufacturers to share drug samples for bioequivalence testing. Finally, the FDA can provide earlier guidance on bioequivalence determinations for complex generic products and adopt the presumption that late-filed citizen petitions should be summarily rejected.

中文翻译:

延迟仿制药进入市场的策略

美国处方药支出的增加主要是由高品牌药价格推动的。尽管仿制药竞争有助于降低药品价格,但品牌药的制造商通常会努力推迟其产品仿制药的供应。阻止仿制药竞争的策略包括为不增加临床价值的药物或改良制剂的外围方面申请专利,支付仿制药制造商以解决质疑品牌药专利有效性的诉讼(“反向支付”和解),拒绝仿制药制造商进入生物等效性测试所需的药物样本、滥用风险评估和缓解策略,以及向美国食品和药物管理局 (FDA) 提交公民申请。针对此类策略,联邦政府可以更严格地解释现有的专利标准,并促进某些类型的专利挑战,以确保专利仅针对真正的创新授予或维护。国会可以颁布待定的立法,这将有助于阻止反向支付结算,并迫使品牌制造商共享用于生物等效性测试的药物样本。最后,FDA 可以为复杂的仿制药产品的生物等效性确定提供更早的指导,并采用延迟提交的公民申请应被立即拒绝的假设。国会可以颁布待定的立法,这将有助于阻止反向支付结算,并迫使品牌制造商共享用于生物等效性测试的药物样本。最后,FDA 可以为复杂的仿制药产品的生物等效性确定提供更早的指导,并采用延迟提交的公民申请应被立即拒绝的假设。国会可以颁布待定的立法,这将有助于阻止反向支付结算,并迫使品牌制造商共享用于生物等效性测试的药物样本。最后,FDA 可以为复杂的仿制药产品的生物等效性确定提供更早的指导,并采用延迟提交的公民申请应被立即拒绝的假设。
更新日期:2017-11-01
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