Addressing Generic Drug Unaffordability And Shortages By Globalizing The Market For Old Drugs

Dramatic increases in the price of generic drugs have focused the attention of policymakers and the public on the limitations of marketplace economics as a means of managing drug costs and access. In recent years, prices have increased sharply for established products that have been in use for 50 years or more. These include colchicine for gout (50-fold), digoxin for heart failure (6-fold), and isoproterenol for heart rhythm abnormalities (5-fold). In one prominent example, Turing Pharmaceutical raised the cost of pyrimethamine (Daraprim), a 62-year old treatment for toxoplasmosis by over 5,000 percent, from $13 to $750 per tablet. Meaningful intellectual property ownership for these older medications expired decades ago and they are now subject to massive price increases or severe shortages. This need not be the case, and there are remedies to address these problems. Market Failure And Generic Drugs The 1984 Hatch-Waxman Act, which gave rise to the modern generic drug industry, was intended to create competition in the production of older, non-patent-protected prescription drugs by providing a shortened pathway for generic manufacturers to obtain Food and Drug Administration (FDA) approval. Instead of requiring companies to conduct expensive clinical trials to prove that their generic versions of old drugs are safe and effective, the 1984 law changed the rules to merely require proof that a generic product is bioequivalent, which usually involves in vitro studies and straigh...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Costs and Spending Drugs and Medical Technology Health Policy Lab Payment Policy Public Health Big Pharma Daraprim generic drugs Hatch-Waxman Act Turing Pharmaceuticals Source Type: blogs