Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast track, accelerated approval, priority review, and...

Zollbeamte müssen ein hohes Maß an Warenkunde beherrschen, um die vielfältigen Waren, die grenzüberschreitend gehandelt werden, zolltariflich, aber auch VuB-rechtlich einstufen zu können. Ein rechtlicher Grundsatz in Deutschland ist dabei: Es handelt sich entweder um ein Arzneimittel nach...

This paper examines the rise and fall of the Administrative Bureau of Prohibited Drugs in 1920s Shanghai. It identifies the factors associated with the endeavours of the central government to experiment with establishing a Bureau dedicated to regulating refined drugs and the reasons why the...

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-19; HCoV-19; COVID-19) has affected all daily activities. Has it also affected the number of United States (FDA) drug approvals over time? The short answer from empirical time series forecasting is not yet. Care should be taken as the crisis...

The clinical stage of drug approval processes commonly starts with a safety test, and if it is successful, efficacy and further safety tests follow. This paper examines how the sequence of these tests affects pharmaceutical companies’ choice of drugs to develop. The safety-first testing...

Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to innovate around this...

We explore how the Patent Office may improve the quality of issued patents on “secondary” drug features by giving examiners more time to review drug-patent applications. Our findings suggest that current time allocations are causing examiners to issue low quality secondary patents on the...

The US Food and drug Administration (FDA) is estimated to regulate markets accounting for about 20% of consumer spending in the US. This paper proposes a general methodology to evaluate FDA policies, in general, and the central speed-safety tradeoff it faces, in particular. We apply this...

The United States spends twice as much per person on pharmaceuticals as European countries, in large part because prices are much higher in the US. This fact has led policymakers to consider legislation for price controls. This paper assesses the effects of a US international reference pricing...

Fragmented healthcare received from many different physicians results in higher costs and lower quality, but does it contribute to dangerous opioid prescribing? The effect is theoretically ambiguous because fragmentation can trigger costly coordination failures but also permits greater...

For nearly 3 years now, Lebanon has been assailed by compounded crises. With the economic instability, the coronavirus pandemic, and the explosion of the Beirut Port on August 4, 2020; the fragile Lebanese healthcare system has found itself at massive risk of a catastrophic public health crisis...

Absent explicit quotas, incentives, reporting, or fiscal year-end motives, drug approvals around the world surge in December, at month-ends, and before respective major national holidays. Drugs approved before these informal deadlines are associated with significantly more adverse effects,...

The FDA is responsible for the approval of new drugs, biological products and medical devices in the United States. As part of the approval process, the FDA relies on advisory committees, which provide independent advice from outside experts. We combine a structural approach with newly collected...

Pharmaceutical companies often replace prescription drugs that are already on the market with modified versions that have the same active pharmaceutical ingredient. On the surface, such activity seems benign and perhaps even salutary. Nonetheless, antitrust litigation has revealed that firms...

The Food and Drug Administration uses committees of experts to evaluate potential new drugs. Weeks before they meet, the experts receive nonpublic reports from drug firms and FDA staff. We find significant abnormal options trading before meeting dates and report creation dates, particularly for...

Member States and many stakeholders, including pharmacy organisations, have signalled a rise in shortages of medicinal products in the European Union (EU). Shortages present a major problem for the quality and continuity of patient care. At best, patients can be provided with an equivalent...

On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved aducanumab, a therapy for the treatment of Alzeihmer’s disease sponsored by Biogen and set to be commercialized under the brand name Aduhelm. Aduhelm was the first treatment for Alzeihmer’s approved by the FDA since 2003....

Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within specified time periods. In turn, the FDA was permitted to levy user fees on drug sponsors...

The attention-grabbing hypothesis has been offered as a behavioural explanation for post-event abnormal returns for FDA drug approval announcements for NYSE listed firms. We show that when event-day mis-specification is accounted for the market reaction is centred on the event-day and that the...

Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality certification. We combine data on...

Biologics accounted for roughly $145 billion in spending in 2018 (IQVIA, 2019). They are also the fastest growing segment of the pharmaceutical industry. The Biological Price Competition and Innovation Act (BPCIA) of 2010 created an abbreviated pathway for biosimilar products to promote price...

This paper revisits Peltzman (1973) in light of two recent opportunities to quantitatively assess tradeoffs in drug regulation. First, reduced regulatory barriers to drug manufacturing associated with the 2017 reauthorization of Generic Drug User Fee Amendments were followed by significantly...

This paper revisits Peltzman (1973) in light of two recent opportunities to quantitatively assess tradeoffs in drug regulation. First, reduced regulatory barriers to drug manufacturing associated with the 2017 reauthorization of Generic Drug User Fee Amendments were followed by significantly...