Pharmacy Administration, Policy and Regulation Commons^™

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Selective Contracting In Prescription Drugs: The Benefits Of Pharmacy Networks, Joanna Shepherd

Faculty Articles

Selective contracting in health care involves contractual arrangements among insurers and health care providers that give covered individuals a financial incentive to obtain health care from a limited panel of providers. Although selective contracting has been an important strategy of health insurance plans for decades, it has only recently expanded to prescription drug coverage. Drug plans now create pharmacy networks that channel customers to in-network pharmacies. Pharmacies compete to be part of the networks by offering discounts on the drugs they sell to covered customers and drug plans. Although networks can lower prescription drug costs for drug plans and consumers, …

Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley

Georgetown Law Faculty Publications and Other Works

Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to …

Shrinking Drug Costs Without Silencing Pharmaceutical Detailers: Maryland's Options After Sorrell V. Ims Health, Kristina L. Miller

Journal of Health Care Law and Policy

No abstract provided.

Patient Perceptions Of Drug Risks And Benefits, Michael S. Brown, Linda J. Wastila, Carol I. Baras, Louis Lasagna

RISK: Health, Safety & Environment (1990-2002)

This is a report of a pilot study conducted to examine patients' perceptions of drug Risks and benefits. While all of the factors influencing such perceptions are important, the findings about the extent to which views are affected by patient understanding of and confidence in regulatory oversight should be of professional interest to an especially broad audience.