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© St. Petersburg Times, published October 22, 2002
WASHINGTON -- Brand-name drug manufacturers were unusually subdued Monday in reaction to President Bush's decision to limit their ability to use litigation to delay competition from generic drugs.
Although the pharmaceutical industry strongly opposed any such action when it was under consideration in Congress not long ago, Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, said industry executives were too surprised by the president's announcement to be able to respond.
"This is a complex issue," said Trewhitt, "and we need more time to look at it."
The industry was unprepared for the announcement primarily because Bush had spoken out against the measure as recently as July 18, saying, "It will not provide lower drug prices."
Bush's policy would eliminate the ability of major drug manufacturers to extend their patents after they expire simply by filing multiple infringement suits against the company wanting to produce a generic equivalent at a lower price. The president now thinks it will save Americans about $3-billion a year.
His action was widely seen as a clever political move to bolster the campaigns of Republicans in parts of the country with high senior populations, such as Florida, where his brother faces re-election. It was expected to mollify seniors angry with Democrats and Republicans for failing to enact a prescription drug benefit for seniors.
Just a few months ago, PhRMA insisted that a proposal similar to this one would destroy a delicate balance in the current law between promoting innovation by the brand name companies and giving patients access to lower-priced generics. Trewhitt said the organization might change its position after reviewing the details of Bush's action.
The idea was first proposed in the Senate earlier this year by Sens. Charles Schumer, D-N.Y., and John McCain, R-Ariz. The Senate adopted it as part of a Medicare reform measure that was never passed; the House never brought it up for a vote.
In his July statement on the subject, Bush said such a move by Congress "would unnecessarily encourage litigation around the initial approval of new drugs and would complicate the process of filing and protecting patents on new drugs. The resulting higher costs and delays in making new drugs available will reduce access to new breakthrough drugs."
His position at that time was consistent with that of the industry.
Administration officials said the president's action had been under consideration for more than a year in the Department of Health and Human Services. But they could not explain why Bush never spoke out in favor of it during that period. They noted the administration's approach is somewhat less restrictive than that of the Schumer-McCain bill.
Speaking to reporters in the Rose Garden on Monday morning, Bush said he had directed the Food and Drug Administration to carry out this action without legislation because he felt the drug industry had taken unfair advantage of the current law.
That law, enacted in 1984, allows brand-name drug companies to have an automatic 30-month extension of their patent while the courts decide on their infringement suit against the generic drugmaker. Bush said the companies had abused this provision by filing multiple suits and thus obtaining multiple 30-month extensions.
"When a drug patent is about to expire," the president explained, "one method some companies use is to file a brand new patent on a minor feature such as the color of the pill bottle or a specific combination of ingredients unrelated to the drug's effectiveness. In this way, the brand name company buys time through repeated delays . . .
"In the meantime, the lower cost generic drug is shut out of the market. These delays have gone on, in some cases, for 37 months or 53 months or 65 months."
The patents on a number of popular brand-name drugs are scheduled to expire in the next year.