Lachman CONSULTANTS - Bob Pollock先生 2014-07-21
校译：识林-椒 2014-07-22
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OGD to Reach Decision Soon on Stability Requirements for RTR ANDAs First Submitted Before June 20, 2014
Written by Bob Pollock • July 21, 2014
If you are one of the about 600 ANDA applicants submitted in the first 19 days of June, or have one of the additional ~ 100-200 ANDAs that have not yet received notification of acceptance for ANDAs submitted prior to June 2014, a decision is expected soon on what stability requirements you will need to meet upon resubmission. This issue was previously raised in a blog post here.
Everyone is holding their breath relative to the OGD’s yet-to-be-made decision. We hope to report on it to let you know as soon as we find out. Until then, keep your ears to the ground and hope for the best!
These are important questions, and it is nice to know that OGD recognizes the need to make decisions on these issues quickly so the industry can have some certainty. I have been at the Hatch-Waxman game for over 30 years now, and the one thing I learned early on, is that there is no way to answer all of the questions or consider all of the scenarios that may come up in advance. Just look at the likes of the Mova decision that threw 180-day exclusivity into a tizzy. Another example relates to the 5-year award of NCE, when considering combination products, when only one of the drugs in the combination has never been approved before. We know it can take only one court decision to change a past precedent or reexamination of a previous decision in light of a new view at FDA, or as presented by industry. So, in this fluid and dynamic environment of the generic drug review and approval process, change will raise new questions, and some answers will be challenged in court or past precedents will be revised. This is not an industry or time for the faint of heart!
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.
