Communication with Industry on Pre-GDUFA Year 3 ANDAs
Dr. Pepper
ANDAs filed prior to October 1, 2014 fall into two groups. For those filed prior to October 1, 2012 (that is prior to GDUFA), 90% are to be addressed prior to September 30, 2017, the end of GDUFA I. ANDAs filed in GDUFA years 1 and 2 have no action date. In 2013 OGD issued MAPP 5200 which addressed communication with industry regarding review of ANDAs pending at OGD. The original version of MAPP 5200 met with howls of protest from industry since it essentially said there will be no communication, at least no useful communication. In October 2014 OGD announced that they had heard the industry outcry on communications and would revise MAPP 5200. Industry continued to press FDA to live up to the agreement in GDUFA to improve communication with industry, not to reduce it.
So why all this fuss about a MAPP on communication? There is history here. In the period following the passage of the Hatch-Waxman Act, which led to the creation of the Division of Generic Drugs, industry communication was free, perhaps too free. ANDA sponsors were free to literally roam the halls of DGD and to talk to reviewers about progress on the review of their filed ANDAs. In other words communication between FDA and ANDA sponsors was not restricted or controlled (or documented) in any way. Well this unfettered communication led to problems that came out in the generic drug scandal. Specifically it turned out that some reviewers were taking bribes to approve ANDAs ahead of their position in the review queue among other things. It was apparent that allowing unchecked communication between industry and FDA created an environment where sponsors and reviewers engaged in criminal behavior to gain a competitive advantage. Following the scandal FDA clamped down hard on all communication between ANDA sponsors and anyone in the DGD (which later became OGD). Any communication was formal, sponsors requesting telephone conferences or meetings to discuss pre-notified review issues (not review status) and these calls always had at least a reviewer, the reviewers supervisor, and the CSO (now called the RPM). This situation continued until GDUFA. As part of GDUFA industry requested improved communication, especially on review progress. The old answer of “it's in the review queue”, “it’s under review” almost always followed by “call back in 6 months” was not helpful in assessing actual progress of review or predicting possible approval dates in order to get ready for marketing. Sponsors would think they were going to get approval and spend large amounts of money on scale up, validation, and preparation for marketing only to get a major amendment instead of an approval. This led to large financial losses as many commercial batches of product were thrown away. The generic industry is highly competitive, you can’t wait for approval before preparing for market, you need to be ready on day 1 of approval. So after 20 years of this unsatisfactory situation, industry wanted a better idea of where they were in the approval process.
The first version of MAPP 5200 cut off all communication! Given that better communication on status was a key point in GDUFA, this was astounding! So the outcry was significant. FDA backtracked and said they would try harder to develop a meaningful communication system. The next revision was an improvement but still a far cry from doing what they agreed to do in exchange for the GDUFA money. So now, almost at the end of GDUFA year 3 we have another revision which promises some idea of status at least.
However, the system that FDA has built to communicate internally looks fragile. There seem to be too many people who have to do too many things in order to get review status messages to sponsors. In short, it looks like FDA have built a poor system to ensure quality of communication with sponsors. Let us hope it works, but I don't think FDA have their heart in doing a good job of communicating with sponsors.
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.
