“When is a citizen not exactly a citizen? When it’s a pharmaceutical company looking to increase its profits,” writes Consumers Union President Jim Guest in a column in the current issue of Consumers Reports. Jim’s column explains how brand-name drug companies interfere with the marketplace by unfairly blocking generic drugs from competing with the brand names.
The brand-name companies use many weapons to fight cheaper generic drugs. They can file so-called “citizen petitions” with the FDA to challenge the approval of a generic. Yet the overwhelming majority of such petitions filed from 2001-2005 failed to raise genuine issues. But these petitions accomplish their real goal: delaying FDA approval of generics. As the Washington Post reported:
Some at the FDA, as well as leaders in the generic drug industry, complain that “citizen petitions”–requests for agency action that any individual, group or company can file–are being misused by brand-name drug makers to stave off generic competition.
The simple act of filing a petition, they say, triggers another round of time-consuming and often redundant reviews of the generics by the FDA, which can take months or years. In the process, consumers continue to pay millions of dollars more for the brand-name drugs.
As bad as bogus “citizen” petitions are, it gets even worse: brand-companies actually pay off generic companies NOT to bring generics to market. Topping off this sad state of affairs: the FDA is so underfunded, it can’t even process all generic drug applications already in the pipeline. As of February, the Washington Post reported, a record 800 generic applications were waiting to be processed.
Congress needs to act now to get affordable generic drugs into marketplace more quickly. A bipartisan bill introduced earlier this year in the U.S. Senate would be a good first step.