Using Multiple Authorized Generics to Maintain High Prices: The Example of Entacapone.

OBJECTIVES: Brand-name drug manufacturers can market or license authorized generics (AGs), which are the same product sold under a generic name. By contrast, independent generics (IGs) are made by other manufacturers. The brand-name manufacturer of entacapone, a treatment for Parkinson's disease, established 4 AGs before IGs emerged. We used this case study to understand how AGs can affect the length of brand-name exclusivity and robustness of generic competition. METHODS: Using public Food and Drug Administration and court records, we identified the regulatory and legal history for generic entacapone products marketed through 2021. We used Medicare Part D data to estimate trends in use, prices, and spending on entacapone products from 2011 to 2020, comparing actual spending with projected spending if IG competition had begun after expiration of the key patent protecting entacapone (October 2013) and prices had fallen consistent with levels observed for other generic drugs. RESULTS: From 2012 to 2014, 3 potential entacapone IG manufacturers instead launched AG versions after settlement agreements with the brand-name manufacturer; the brand-name manufacturer additionally introduced its own AG. Four different IG versions were marketed beginning in 2015. From 2011 to 2020, average Medicare prices declined by 62%, less than the projected 74% to 92% price decline expected for a drug with 8 generics. Over this period, Medicare spent $1.1 billion on entacapone products, which could have been reduced by an estimated $137 to $449 million through typical IG competition. CONCLUSIONS: The case of entacapone demonstrates how licensing multiple AGs in place of IG competition can increase spending. Government regulators should more rigorously monitor AGs to prevent such strategies.

Trust and Regulation: Assuring Scientific Independence in the FDA's Emergency Use Authorization Process.

Since 2004, the US Food and Drug Administration (FDA) has had the authority to allow access to unapproved medical products via the Emergency Use Authorization (EUA) pathway during times of emergency. It was rarely used until the COVID-19 pandemic, when concerns arose regarding the role of political pressure in the FDA's issuance of some EUAs, such as for hydroxychloroquine. Although US government officials should be responsive to the public, democratic accountability must be balanced against the need for thoughtful science-based decision-making. Inadequate agency independence can diminish public confidence in government leaders and the FDA. To consider whether reform of the EUA process might be appropriate, we considered three possible sources of inspiration for balancing independence and accountability in government scientific decision-making: models in other countries, models in other US agencies, and models within the FDA itself. Strategies used in these settings include: (1) expanding the role of advisory committees, (2) increasing transparency of the agency's decision-making process and supporting rationale, and (3) improving management of internal agency disagreement. Such reforms could improve public trust in public health regulation both related to and separate from future emergencies.

The $5 Billion Hop: Glatiramer Acetate and the US Patent System.

New research and a government investigation have shed light on an anticompetitive practice called "Product Hopping" and specifically how it was employed in the case of the multiple sclerosis treatment glatiramer acetate beginning in 2014, which cost payers billions of dollars. We examine this case as well as a separate, impending instance of product hopping.

Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021.

This cohort study assesses whether drugs with the most direct-to-consumer television advertising represent advances over existing treatments.