Magazine article Drug Topics

GPOs: Another Subject under FTC Scrutiny

Magazine article Drug Topics

GPOs: Another Subject under FTC Scrutiny

Article excerpt


Drugmakers and consumer groups reacted last month to news that federal trade regulators are urging Congress to pass a law that could tilt the prescription drug market away from brandname pharmaceuticals toward lower-cost generics. The recommendations-issued this summer by the Federal Trade Commission-- are the latest in the ongoing debate over rising prescription drug prices and the continued wrangling over how to add an Rx drug benefit to the federal Medicare program. They also represent a setback for brand-name drugmakers, who are fighting to keep lawmakers from changing existing drug patent laws in a way that could make it easier for generic competitors to increase their market share.

Regulators discussed their recommendations at an FTC forum in Washington, D.C., in which some of the loudest voices in the prescription drug debate aired their views on federal patent laws.

The FTC released a study in late July warning that an existing drug patent law, the Waxman-Hatch Act of 1984, was vulnerable to abuse by companies who wanted to game the system in the courts. The main source of trouble is a provision granting an automatic 30-month delay in approval of a generic copy if a brand-name manufacturer files a lawsuit alleging patent infringement.

Generic drugmakers and many consumer groups have long complained that brand-name drugmakers skirt the law's intent by filing frivolous patents on soon-to-expire drugs. The practice, they say, can end up in multiple 30-month stays that keep a generic drug off the market for much longer than the law ever intended.

The FTC proposes that Congress allow only one 30-month stay per drug, regardless of how many patents a brand-name drugmaker files. That recommendation follows on an FTC study of 104 generic drug applications showing that prescription drugmakers have been filing more and more patents on expiring drugs since 1998, in a possible attempt to use lawsuits to delay generic competition.

The recommendation also forms the core of a Senate bill passed in July that supporters said was designed to force brand-name drugmakers to shift market share toward generic drugs. Analysts have suggested that the changes could save the U. …

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