Lachman CONSULTANTS - Bob Pollock先生 2014-09-10
校译：识林-椒 2014-09-11
GPhA Annual Cost Savings Report Shows Larger Savings for the US Public
Written by Bob Pollock • September 10, 2014
The Congressional Budget Office (CBO) report last month indicated that the cost of health care programs has slowed sharply. A large part of the savings is attributed to the cost savings realized through the use of generic drugs. This year's GPhA Cost Savings report showed that consumers (including the US Government) saved $239 million alone in 2013 an increase of 14% over the savings seen in 2012.
Generic Cost savings 2004-2013
Source: IMS Institute for Healthcare Informatics' report
The 10 year savings from generic availability is reported at $1.5 trillion over the last 10 year period.
“The report confirms that the story of generic savings remains one of growth. In addition to the yearly growth of the savings totals, the report reveals that new generic products coming to market in 2013 saved the U.S. health system $140 billion alone. Established generic products continue to provide cost savings and, in 2013, they accounted for $98 billion in savings.”(the GPhA release says)
This report comes days before the 30th anniversary of the Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act of 1984). The news is good and points out the importance of the legislation in terms of reducing associated health care costs in this country. This is one of (if not the most) successful piece of legislation with regards to reducing the trend of increases in health care costs that has ever been enacted.
The generic drug industry and GPhA continue to support the Office of Generic Drugs program in its efforts to bring more affordable generic drug products to market.
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.
