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The president will announce today steps to close loopholes in patent law that lead to delays in generic drug availability.
By SARA FRITZ, Times Washington Bureau Chief
© St. Petersburg Times, published October 21, 2002
WASHINGTON -- President Bush, in an election season bid for Republican support from seniors, will announce today that his administration is taking steps to limit litigation that often causes long delays in the availability of generic drugs.
In an early morning Rose Garden ceremony, Bush will direct the government to embrace most of the provisions contained in a bill authored earlier this year by Sens. Charles Schumer, D-N.Y., and John McCain, R-Ariz. The Senate passed the measure, but opposition from the pharmaceutical industry prevented it from being considered in the Republican-controlled House.
The president never spoke out in favor of the idea when it was being considered on Capitol Hill, and his advisers questioned whether it would save seniors money. Now, however, the administration estimates the savings will be about $3-billion a year.
Bush's action is sure to be welcomed by many Americans who have no drug coverage, especially Medicare beneficiaries. Thus it may bolster the campaigns of Republican candidates in areas with high senior populations, including the president's brother, Florida Gov. Jeb Bush .
Democrats are certain to see this action as a kind of "October surprise," which could deprive their candidates of an opportunity to blame Republicans and the Bush administration for doing too little to help people with high drug expenses.
Schumer was skeptical about the White House move.
"This sounds like an Election Day conversion," Schumer said in a statement Sunday night. "The devil will be in the details."
"This could be a very 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," Schumer said. "We'll have to examine the details very closely."
Until now, the Bush administration has been reluctant to take any steps to assist Americans with drug expenditures that were opposed by the pharmaceutical industry. The centerpiece of Bush's program to help the uninsured has been a drug discount card that had the support of the manufacturers, but was stymied by a court suit brought by drugstores.
Drug industry officials could not be reached for comment on Sunday night, but they are likely to challenge the president's action on grounds that it cannot be done without a vote in Congress.
A top administration official, who declined to be identified by name, told reporters Sunday night that the action will be published in the Federal Register this week and implemented after a 60-day comment period. The official said the administration thinks the action is legally solid. In essence, the president's plan will close loopholes in current patent law that allow the big brand-name drug manufacturers to use the courts to delay generic competition once the patent has expired on one of their blockbuster drugs. These drugs earn the companies millions of dollars each day, so the cost of litigation does not prevent them from bringing cases that are without legal merit.
Earlier this year, the Federal Trade Commission concluded an investigation of eight prominent cases in which drug companies used a litigation strategy to delay generic competition on such drugs as Taxol, a chemotherapy drug commonly used for breast cancer, and Paxil, a popular antidepressant. The administration said the president was acting in response to the FTC report, which was issued this summer.
The law provides brand-name drug companies an automatic 30-month extension of their patent if they go to court to challenge a generic version of their drug on infringement issues. By claiming to have a patent on their packaging and various modifications to their brand-name drug, they can often win multiple 30-month extensions.
Like the Schumer-McCain bill, the administration's action would essentially limit each brand-name drug to only one 30-month extension beyond the 20-year life of the patent. The FTC says most legitimate infringement cases can be litigated in 30 months.
The administration's action is not identical to the Schumer-McCain bill, which White House officials opposed when it was being considered in the Senate. The administration's sudden reversal on this issue appears to be the handiwork of Mark McClelland, the former White House aide who was confirmed by the Senate last week to head the Food and Drug Administration.
-- Information from the Associated Press was used in this report.