Robin Feldman, an expert in drug patents and generics from the University of California Hastings College of Law, discusses the tactics employed by pharmaceutical companies to reduce competition from generic drugs. Topics include the Hatch-Waxman Act, weak patents, pay for delay settlements, evasion of price controls, complexities of drug pricing, and challenges in replacing branded drugs with ineffective capsules.
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Quick takeaways
Pharmaceutical companies employ tactics to reduce competition from generic drugs, leading to higher prices for consumers.
Citizen petitions are being exploited by pharmaceutical companies to delay entry of generic drugs, highlighting the need for transparency and oversight.
Continuous reform is needed to address evolving challenges in the pharmaceutical industry and ensure alignment with public interest over excessive profits.
Deep dives
The Complexity of the Pharmaceutical Patent System
The speaker discusses the complexities of the pharmaceutical patent system, where drug companies often employ tactics such as pay-for-delay and evergreening to extend their market exclusivity. These tactics hinder the entry of generic drugs into the market, leading to higher prices for consumers. The speaker argues for the need to simplify the system and create better alignment between the goals of society and the incentives of pharmaceutical companies.
The Role of Citizen Petitions in Delaying Generic Competition
Citizen petitions, which were intended to give ordinary citizens a voice, have been increasingly exploited by pharmaceutical companies to delay the entry of generic drugs. These petitions often make questionable claims and seek to block competition. While the FDA denies the petitions in most cases, the process still takes time, allowing companies to enjoy additional unchallenged sales. The speaker highlights the need for greater transparency and oversight in citizen petition procedures.
Addressing Flaws in the Healthcare System
The speaker acknowledges the flaws in the healthcare system, including the third-party payment system and the complexities of the FDA. However, she emphasizes the importance of creating functioning competitive markets, simplifying regulations, and increasing transparency as ways to improve the system and align the incentives of pharmaceutical companies with the goals of society.
The Positive Impact of Hatch-Waxman
Hatch-Waxman has played a pivotal role in promoting the entry of generic drugs into the market, leading to lower prices and increased competition. It has been successful in shifting the pharmaceutical industry towards a system of generics. However, the speaker highlights the need to protect Hatch-Waxman from new waves of game playing and maintain its effectiveness in the face of evolving tactics to delay generic competition.
The Need for Continuous Reform
While Hatch-Waxman has been a major step forward, continuous reform is required to address the ever-evolving challenges in the pharmaceutical industry. Reforms should focus on simplifying the system, enhancing transparency, and creating stronger incentives for pharmaceutical companies to prioritize public interest over excessive profits.
Robin Feldman of the University of California Hastings College of Law and author of Drug Wars talks about her book with EconTalk host Russ Roberts. Feldman explores the various ways that pharmaceutical companies try to reduce competition from generic drugs. The conversation includes a discussion of the Hatch-Waxman Act and the sometimes crazy world of patent protection.
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