FDA Plans to Speed Up Flow Of Generics to Marketplace
By CHRIS ADAMS
Staff Reporter of THE WALL STREET JOURNAL
WASHINGTON -- The Food and Drug Administration is planning a new rule designed to help generic drugs get to market sooner, seeking to ease one of the longstanding complaints against brand-name drug makers.
In a rule to be proposed Monday, the FDA will attempt to eliminate some of the methods used by brand-name drug makers to delay the introduction of low-cost generic competitors. The rule is subject to public comment before becoming final, and likely will be strongly opposed by big pharmaceutical companies.
In taking the action, the Bush administration is stepping directly into a debate that has raged this year in Congress. The Senate, controlled by Democrats, this summer passed a bill addressing some of the same issues, but the legislation died in the Republican-controlled House amid heavy brand-name drug-industry opposition. Meanwhile, Congress again failed this year to provide a prescription-drug benefit for Medicare patients.
The move could have important implications for the coming midterm elections, as Republicans will be able to say they have taken steps to reduce the cost of drugs. President Bush and top health officials will formally announce the proposal this morning, according to a senior administration official, who described it as an attempt to "close unfair loopholes" and "reduce the cost of prescription drugs."
Sen. Charles Schumer, the New York Democrat who has championed the issue in the Senate, responded to the Bush administration proposal with some skepticism. "This could be a really good proposal, but given the White House's track record on this issue, it could be just another loophole to let the name-brand drug companies delay the implementation of generic drugs," he said.
The administration estimates that the moves would save drug buyers -- the government, employers and consumers -- more than $3 billion a year, according to the senior administration official.
The technical details of the rule already have been endlessly debated by generic-drug makers and their brand-name competitors. A 1984 law has had a significant impact in boosting the share of all prescriptions that are filled by low-cost copycats. At the same time, however, generic-drug makers say that, in recent years, brand-name competitors have employed legal and regulatory tricks to prevent the smooth entry of low-cost generics. The brand-name companies say they are merely taking appropriate steps to guard their intellectual-property rights.
One tactic used by brand-name drug makers is to receive multiple 30-month delays against generic entry. The new proposal generally would limit drug makers to just one 30-month stay. The proposal also seeks to reduce the filing of "frivolous" patents with the FDA, which can tangle the ability of a generic firm to bring its drug to market.
Officials from Pharmaceutical Research and Manufacturers of America had no comment last night. Kathleen Jaeger, who heads the Generic Pharmaceutical Association, said the administration was "moving in the right direction."
Write to Chris Adams at chris.adams@wsj.com
Updated October 21, 2002
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