FDA拟议规定允许仿制药ANDA持有者单方面变更药品安全性警告，这一极具争议的拟议规定一经提出便引来百家争鸣，参议院健康教育劳工与养老委员会副主席、参议员Lamar Alexander，以及司法委员会主席、众议员Bob Goodlatte两人，要求白宫信息及法规事务办公室(Office of Information and Regulatory Affairs, OIRA) 的行政管理及预算办公室对于FDA在此事中的立场做出些许解释。
Lachman CONSULTANTS - Bob Pollock先生 2014-06-26
校译：识林-柯 2014-06-28
识林www.shilinx.com，版权所有，如需转载请注明出处
Senator Alexander and Representative Goodlatte Grill OMB on Proposed Generic Drug Labeling Rule
Written by Bob Pollock • June 26, 2014
In the latest salvo fired over the controversial FDA proposed rule that would permit generic drug ANDA holders to unilaterally change their drug product warnings, Senator Lamar Alexander, Ranking Member, Committee on Health, Education, Labor & Pensions and Congressman, and Bob Goodlatte, Chairman of the Judiciary Committee asked the Office of Management and Budget's Administrator of the Office of Information and Regulatory Affairs (OIRA) to explain a few things about the FDA position.
They asked for an explanation of how the FDA could reach a conclusion that the proposed rule does not violate the “sameness” provisions of the Hatch-Waxman Act, how the economic impact analysis appeared to ignore certain big ticket items like liability expenses and other labeling costs associated with the proposed rule, as well as why the FDA really changed its mind about its own long-held position that generic applicants were not permitted to do so, which it has stated over and over ever since the passage of the Hatch-Waxman Act, in its Amicus brief in the Mensing case and in various petition responses and Guidance documents the Agency has issued over the last 30 years.
They also asked for a briefing by OIRA to address the issues raised in the letter.
So another Congressional inquiry is now open to see just how and why the FDA changed its stripes on this tiger. Let's hope enough is being done to undo the potential damage of this proposed rule to the American public and the industry.
Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act)
Mandatory Reading:
Regulatory Affairs (Reg)
Intellectual Property (IP)
Quality Assurance (QA)
Legal Department
Work Suggestions:
Reg: Ensure the company's drug applications comply with the new drug application procedures and bioequivalence standards.
IP: Monitor patent term extensions and the impact on the company's patent strategy.
QA: Verify that manufacturing processes meet the identity, strength, quality, and purity requirements.
Legal Department: Advise on patent infringement issues and the legal implications of abbreviated new drug applications.
Scope of Application: The Drug Price Competition and Patent Term Restoration Act of 1984 applies to chemical drugs, including new molecular entities and generic drugs, in the United States. It is intended for regulatory bodies, pharmaceutical companies, and legal entities involved in drug development and approval processes.
Key Points Summary:
Abbreviated New Drug Applications (ANDAs): The Act allows for the streamlined approval of generic drugs by submitting abbreviated applications showing bioequivalence to the listed drug, without repeating costly and time-consuming clinical trials.
Patent Term Restoration: Offers a mechanism to extend the effective patent life of a drug to partially compensate for the time lost during the regulatory review process, up to a maximum of five years.
Data Exclusivity: Provides a period of data exclusivity, during which the FDA cannot approve ANDAs for other companies that rely on the innovator's safety and efficacy data.
Patent Certification: Requires ANDA applicants to certify about the listed drug's patents or periods of exclusivity, which can trigger a patent infringement lawsuit.
Regulatory Review Period: Defines the regulatory review period for calculating patent term extensions and sets rules for due diligence during the application process.
Conclusion: The Drug Price Competition and Patent Term Restoration Act of 1984 is a landmark legislation that balances the need for accessible, affordable medications with the incentive for innovation. It has significantly impacted the pharmaceutical industry by fostering competition and ensuring that both innovator and generic drug companies have clear pathways to market. The above points are not exhaustive; for comprehensive understanding, the full text of the Act should be consulted.
。